Farapti Farapti, Sheila Amara Putri, Annisaa Wulida Furqonia, Purwo Sri Rejeki, Muhammad Miftahussurur
Background: Hypertension increases with age, often due to high sodium (Na) and low potassium (K) intake. Reducing salt and increasing K intake is challenging, especially for older adults due to taste preferences. Culinary herbs and spices, rich in K, offer a potential solution. The High Potassium Diet Rich in Spices and Herbs-Salt Substitution (HPSH-SS) diet has not yet been studied for its effectiveness in lowering blood pressure.
Objective: This study aims to create an HPSH-SS diet, analyze its effects on blood pressure in older adults, and study the molecular mechanism occurring in the kidneys and blood vessels influenced by this diet.
Methods: This study consists of 2 phases. The first phase involved formulating and assessing the HPSH-SS diet tailored for older adults. The intervention group (IG) received a diet of 1800 kcal/day, with 3500 mg K and 1500 mg Na, while the control group (CG) received 1500 mg K and 2000 mg Na. The diet was administered for 14 days and standardized using the NutriSurvey program and biochemistry analysis by atomic absorbance spectrophotometry (AAS). The second phase was a 14-day parallel randomized controlled trial (RCT) with the older adult participants divided into IG and CG. Primary outcomes included blood pressure; serum potassium; aldosterone; F2 isoprostane; nitric oxide plasma levels; and urine analysis of Na, K, and the Na/K ratio. Confounding variables were controlled through randomization and stratified analysis.
Results: The menu formulation and organoleptic assessment of the HPSH-SS diet began in mid-2022 and was approved by the Ethics Committee of the Faculty of Public Health at Universitas Airlangga (78/EA/KEPK/2022) on May 11, 2022. The diet was standardized to achieve daily nutritional values of 1800 kcal energy, 3500 mg K, and 1500 mg Na. K and Na contents were analyzed using AAS from several participants' spice diet menus. Recruitment for the RCT started in March 2023, with approval from the Health Research Ethics Committee Universitas Airlangga School of Medicine, Surabaya (35/EC/KEPK/FKUA/2023). The study was registered from February 9, 2023, to February 9, 2024. Between March and June 2023, 64 participants were recruited, with 32 participants in the IG and CG. The intervention and data collection will take place over 1 year. Data management is in progress, and data analysis is yet to be performed.
Conclusions: This RCT protocol hypothesizes that the diet will increase serum K, plasma aldosterone, and nitric oxide levels; decrease plasma F2 isoprostane; increase urinary Na and K levels; lower the urinary Na/K ratio; and reduce systolic and diastolic blood pressure. If effective, it will offer valuable insights into dietary strategies for blood pressure regulation in older adults.
International registered report identifier (irrid): DERR1-10.2196/56869.
{"title":"High Potassium Diet Rich in Spices and Herbs-Salt Substitution (HPSH-SS) for Blood Pressure Reduction in Older Adults: Protocol for Diet Concept and Randomized Controlled Trial.","authors":"Farapti Farapti, Sheila Amara Putri, Annisaa Wulida Furqonia, Purwo Sri Rejeki, Muhammad Miftahussurur","doi":"10.2196/56869","DOIUrl":"10.2196/56869","url":null,"abstract":"<p><strong>Background: </strong>Hypertension increases with age, often due to high sodium (Na) and low potassium (K) intake. Reducing salt and increasing K intake is challenging, especially for older adults due to taste preferences. Culinary herbs and spices, rich in K, offer a potential solution. The High Potassium Diet Rich in Spices and Herbs-Salt Substitution (HPSH-SS) diet has not yet been studied for its effectiveness in lowering blood pressure.</p><p><strong>Objective: </strong>This study aims to create an HPSH-SS diet, analyze its effects on blood pressure in older adults, and study the molecular mechanism occurring in the kidneys and blood vessels influenced by this diet.</p><p><strong>Methods: </strong>This study consists of 2 phases. The first phase involved formulating and assessing the HPSH-SS diet tailored for older adults. The intervention group (IG) received a diet of 1800 kcal/day, with 3500 mg K and 1500 mg Na, while the control group (CG) received 1500 mg K and 2000 mg Na. The diet was administered for 14 days and standardized using the NutriSurvey program and biochemistry analysis by atomic absorbance spectrophotometry (AAS). The second phase was a 14-day parallel randomized controlled trial (RCT) with the older adult participants divided into IG and CG. Primary outcomes included blood pressure; serum potassium; aldosterone; F2 isoprostane; nitric oxide plasma levels; and urine analysis of Na, K, and the Na/K ratio. Confounding variables were controlled through randomization and stratified analysis.</p><p><strong>Results: </strong>The menu formulation and organoleptic assessment of the HPSH-SS diet began in mid-2022 and was approved by the Ethics Committee of the Faculty of Public Health at Universitas Airlangga (78/EA/KEPK/2022) on May 11, 2022. The diet was standardized to achieve daily nutritional values of 1800 kcal energy, 3500 mg K, and 1500 mg Na. K and Na contents were analyzed using AAS from several participants' spice diet menus. Recruitment for the RCT started in March 2023, with approval from the Health Research Ethics Committee Universitas Airlangga School of Medicine, Surabaya (35/EC/KEPK/FKUA/2023). The study was registered from February 9, 2023, to February 9, 2024. Between March and June 2023, 64 participants were recruited, with 32 participants in the IG and CG. The intervention and data collection will take place over 1 year. Data management is in progress, and data analysis is yet to be performed.</p><p><strong>Conclusions: </strong>This RCT protocol hypothesizes that the diet will increase serum K, plasma aldosterone, and nitric oxide levels; decrease plasma F2 isoprostane; increase urinary Na and K levels; lower the urinary Na/K ratio; and reduce systolic and diastolic blood pressure. If effective, it will offer valuable insights into dietary strategies for blood pressure regulation in older adults.</p><p><strong>International registered report identifier (irrid): </strong>DERR1-10.2196/56869.</p>","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":null,"pages":null},"PeriodicalIF":1.4,"publicationDate":"2024-10-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142521895","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Luca Bertolaccini, Oriana CIani, Marco Lucchi, Francesco Zaraca, Alessandro Bertani, Roberto Crisci, Lorenzo Spaggiari
[This corrects the article DOI: 10.2196/57183.].
[此处更正了文章 DOI:10.2196/57183]。
{"title":"Correction: Outcomes of Patients With Early and Locally Advanced Lung Cancer: Protocol for the Italian Lung Cancer Observational Study (LUCENT).","authors":"Luca Bertolaccini, Oriana CIani, Marco Lucchi, Francesco Zaraca, Alessandro Bertani, Roberto Crisci, Lorenzo Spaggiari","doi":"10.2196/67629","DOIUrl":"https://doi.org/10.2196/67629","url":null,"abstract":"<p><p>[This corrects the article DOI: 10.2196/57183.].</p>","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":null,"pages":null},"PeriodicalIF":1.4,"publicationDate":"2024-10-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142545585","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Tim Michael Jackson, Kanesha Ward, Shannon Saad, Sarah J White, Shila Poudel, Freya Raffan, Sue Amanatidis, Jenna Bartyn, Owen Hutchings, Enrico Coiera, Kevin Chan, Annie Y S Lau
Background: Virtual care is increasingly incorporated within routine health care settings to improve patient experience and access to care. A patient's experience encompasses all the interactions an individual has with the health care system. This includes a greater emphasis on actively involving carers in the decisions and activities surrounding a patient's health care.
Objective: This study aimed to investigate the variety of health care delivery challenges encountered in a virtual hospital and explore potential ways to improve the patient experience.
Methods: Focusing on acute respiratory, this protocol outlines a mixed methods study exploring the patient experience of a virtual hospital in Australia, Royal Prince Alfred Virtual Hospital (rpavirtual). We will use an exploratory mixed methods approach comprising of secondary data analysis, observations, interviews, and co-design focus groups. Participants will include patients, their carers, and health care workers who are involved in the acute respiratory virtual hospital model of care. Together, the data will be triangulated to explore views and experiences of using this model of care, as well as co-designing recommendations for further improvement.
Results: Findings from this study will identify current barriers and facilitators to implementing virtual care, such as work-as-done versus work-as-imagined, equity of care, the role of carers, and patient safety during virtual care. As of August 2024, a total of 25 participants have been interviewed.
Conclusions: This protocol outlines a mixed methods case study on the acute respiratory model of care from Australia's first virtual hospital, rpavirtual. This study will collect the experiences of patients, carers, and health care workers to co-design a series of recommendations to improve the patient experience.
International registered report identifier (irrid): DERR1-10.2196/58683.
{"title":"Virtual Hospitals and Patient Experience: Protocol for a Mixed Methods Observational Study.","authors":"Tim Michael Jackson, Kanesha Ward, Shannon Saad, Sarah J White, Shila Poudel, Freya Raffan, Sue Amanatidis, Jenna Bartyn, Owen Hutchings, Enrico Coiera, Kevin Chan, Annie Y S Lau","doi":"10.2196/58683","DOIUrl":"https://doi.org/10.2196/58683","url":null,"abstract":"<p><strong>Background: </strong>Virtual care is increasingly incorporated within routine health care settings to improve patient experience and access to care. A patient's experience encompasses all the interactions an individual has with the health care system. This includes a greater emphasis on actively involving carers in the decisions and activities surrounding a patient's health care.</p><p><strong>Objective: </strong>This study aimed to investigate the variety of health care delivery challenges encountered in a virtual hospital and explore potential ways to improve the patient experience.</p><p><strong>Methods: </strong>Focusing on acute respiratory, this protocol outlines a mixed methods study exploring the patient experience of a virtual hospital in Australia, Royal Prince Alfred Virtual Hospital (rpavirtual). We will use an exploratory mixed methods approach comprising of secondary data analysis, observations, interviews, and co-design focus groups. Participants will include patients, their carers, and health care workers who are involved in the acute respiratory virtual hospital model of care. Together, the data will be triangulated to explore views and experiences of using this model of care, as well as co-designing recommendations for further improvement.</p><p><strong>Results: </strong>Findings from this study will identify current barriers and facilitators to implementing virtual care, such as work-as-done versus work-as-imagined, equity of care, the role of carers, and patient safety during virtual care. As of August 2024, a total of 25 participants have been interviewed.</p><p><strong>Conclusions: </strong>This protocol outlines a mixed methods case study on the acute respiratory model of care from Australia's first virtual hospital, rpavirtual. This study will collect the experiences of patients, carers, and health care workers to co-design a series of recommendations to improve the patient experience.</p><p><strong>International registered report identifier (irrid): </strong>DERR1-10.2196/58683.</p>","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":null,"pages":null},"PeriodicalIF":1.4,"publicationDate":"2024-10-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142545592","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Maya Ramsey, Nina Oberman, Charles P Quesenberry, Elaine Kurtovich, Lizeth Gomez Chavez, Aaloni Chess, Susan Denise Brown, Cheryl L Albright, Mibhali Bhalala, Sylvia E Badon, Lyndsay A Avalos
<p><strong>Background: </strong>Postpartum depression (PPD) is associated with significant health consequences for the parent and child. Current recommendations for PPD prevention require intense health care system resources. Evidence-based interventions for PPD prevention that do not further burden the health care system are needed. Evidence suggests that physical activity (PA) can generally reduce depressive symptoms. Technology-based interventions may help decrease common barriers to PA.</p><p><strong>Objective: </strong>This study aims to report the protocol and provide a data overview of the POstpartum Wellness study (POW)-an effectiveness trial evaluating whether an eHealth PA intervention tailored for postpartum individuals increased PA and decreased depressive symptoms among individuals at high PPD risk.</p><p><strong>Methods: </strong>This remote parallel-group randomized controlled trial included postpartum individuals with a history of depression or at least moderate current depressive symptoms not meeting the PPD diagnostic threshold and with low PA levels from an integrated health care delivery system. Participants were randomized to an eHealth PA intervention or usual care. The intervention group received access to a library of web-based workout videos designed for postpartum individuals, which included interaction with their infants. At baseline and follow-up (3 and 6 months), PA was measured using questionnaires and a wrist-worn accelerometer. Depressive symptoms were measured using the Patient Health Questionnaire-8 (PHQ-8). Data were collected to assess exploratory outcomes of sleep, perceived stress, anxiety, parent-infant bonding, and infant development.</p><p><strong>Results: </strong>The study was funded in January 2020. Participants were enrolled via REDCap (Research Electronic Data Capture) or telephonically between November 2020 and September 2022; data collection ended in April 2023. Randomized participants (N=99) were 4 months post partum at baseline with moderately severe depressive symptoms (mean PHQ-8 score 12.6, SD 2.2). Intervention (n=50) and usual care (n=49) groups had similar sociodemographic characteristics, months post partum, baseline depressive symptoms, number of children at home, and prepregnancy PA levels. Retention in assessments was ≥66% for questionnaires and ≥48% for accelerometry, with modest differences by group. At 3-month follow-up, 73 of 99 (74%) participants (intervention: 35/50, 70%; usual care: 38/49, 78%) completed questionnaires; 53 of 99 (54%) wore the accelerometer for 7 days (27 of 50 (54%) intervention, 26 of 49 (53%) usual care). At 6-month follow-up, 66 of 99 (67%) participants (30 of 50 (60%) intervention, 36 of 49 (73%) usual care) completed questionnaires and 43 of 99 (43%) wore the accelerometer for 7 days (21 of 50 (42%) intervention, 22 of 49 (45%) usual care). Data analysis is completed, and a manuscript with these findings is currently under review for publication.</p><p><stro
{"title":"A Tailored Postpartum eHealth Physical Activity Intervention for Individuals at High Risk of Postpartum Depression-the POstpartum Wellness Study (POW): Protocol and Data Overview for a Randomized Controlled Trial.","authors":"Maya Ramsey, Nina Oberman, Charles P Quesenberry, Elaine Kurtovich, Lizeth Gomez Chavez, Aaloni Chess, Susan Denise Brown, Cheryl L Albright, Mibhali Bhalala, Sylvia E Badon, Lyndsay A Avalos","doi":"10.2196/56882","DOIUrl":"10.2196/56882","url":null,"abstract":"<p><strong>Background: </strong>Postpartum depression (PPD) is associated with significant health consequences for the parent and child. Current recommendations for PPD prevention require intense health care system resources. Evidence-based interventions for PPD prevention that do not further burden the health care system are needed. Evidence suggests that physical activity (PA) can generally reduce depressive symptoms. Technology-based interventions may help decrease common barriers to PA.</p><p><strong>Objective: </strong>This study aims to report the protocol and provide a data overview of the POstpartum Wellness study (POW)-an effectiveness trial evaluating whether an eHealth PA intervention tailored for postpartum individuals increased PA and decreased depressive symptoms among individuals at high PPD risk.</p><p><strong>Methods: </strong>This remote parallel-group randomized controlled trial included postpartum individuals with a history of depression or at least moderate current depressive symptoms not meeting the PPD diagnostic threshold and with low PA levels from an integrated health care delivery system. Participants were randomized to an eHealth PA intervention or usual care. The intervention group received access to a library of web-based workout videos designed for postpartum individuals, which included interaction with their infants. At baseline and follow-up (3 and 6 months), PA was measured using questionnaires and a wrist-worn accelerometer. Depressive symptoms were measured using the Patient Health Questionnaire-8 (PHQ-8). Data were collected to assess exploratory outcomes of sleep, perceived stress, anxiety, parent-infant bonding, and infant development.</p><p><strong>Results: </strong>The study was funded in January 2020. Participants were enrolled via REDCap (Research Electronic Data Capture) or telephonically between November 2020 and September 2022; data collection ended in April 2023. Randomized participants (N=99) were 4 months post partum at baseline with moderately severe depressive symptoms (mean PHQ-8 score 12.6, SD 2.2). Intervention (n=50) and usual care (n=49) groups had similar sociodemographic characteristics, months post partum, baseline depressive symptoms, number of children at home, and prepregnancy PA levels. Retention in assessments was ≥66% for questionnaires and ≥48% for accelerometry, with modest differences by group. At 3-month follow-up, 73 of 99 (74%) participants (intervention: 35/50, 70%; usual care: 38/49, 78%) completed questionnaires; 53 of 99 (54%) wore the accelerometer for 7 days (27 of 50 (54%) intervention, 26 of 49 (53%) usual care). At 6-month follow-up, 66 of 99 (67%) participants (30 of 50 (60%) intervention, 36 of 49 (73%) usual care) completed questionnaires and 43 of 99 (43%) wore the accelerometer for 7 days (21 of 50 (42%) intervention, 22 of 49 (45%) usual care). Data analysis is completed, and a manuscript with these findings is currently under review for publication.</p><p><stro","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":null,"pages":null},"PeriodicalIF":1.4,"publicationDate":"2024-10-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142521893","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Background: Parkinson disease (PD) is a progressive neurodegenerative disorder characterized by motor dysfunctions and nonmotor symptoms. Current treatments do not alter disease progression, highlighting the need for alternative therapies. Music, dance, and mindfulness meditation have shown the potential to improve symptoms and quality of life in patients with PD.
Objective: This study aims to evaluate the effectiveness of dance or music and meditation on PD progression, cognitive functions, mood, behavior, and caregiver burden.
Methods: This study is a single-blinded, longitudinal, parallel, randomized controlled trial. The participants consist of 30 patients with mild to moderate PD residing in Mumbai, India, who can physically participate in the activities. The exclusion criteria include advanced PD, severe balance issues, age >80 years, and other movement disorders. Participants in the intervention group will engage in dance or music sessions and guided meditation thrice weekly for 6 months. The control group will continue their usual activities and medication. The primary outcome is the progression of PD symptoms, measured using the Unified Parkinson's Disease Rating Scale I-III, and quality of life, measured using the Parkinson's Disease Questionnaire-39. The secondary outcomes include cognitive functions (Mini-Mental State Examination), mood (Beck Depression Inventory and Parkinson Anxiety Scale), mobility (timed up and go and Berg Balance Test), behavioral disorders (Questionnaire for Impulsive-Compulsive Disorders in Parkinson's Disease Rating Scale), and caregiver burden (Zarit Burden Interview and Parkinson's Disease Questionnaire-Carer).
Results: Data collection was completed in February 2024, with 28 participants finishing the study (intervention group: n=15, 54% and control group: n=13, 46%). Data analysis is underway, with results expected to be published in December 2024.
Conclusions: This study aims to provide significant insights into the effectiveness of dance or music and meditation in improving the quality of life and slowing the progression of PD. The findings are anticipated to support using these nonpharmaceutical therapies as complementary approaches to managing PD.
{"title":"Impact of Dance or Music and Meditation on the Progression of Parkinson Disease With Mild or Moderate Severity: Protocol for a Pilot Randomized Controlled Trial.","authors":"Bhagyashree Mehrotra, Neha Rai, Rajani Mr, Aparna Budhakar, Ritika Aggarwal, Raj Vinodkumar Agarbattiwala, Mona Thomas, Sampada Patole, Paresh Doshi","doi":"10.2196/59018","DOIUrl":"https://doi.org/10.2196/59018","url":null,"abstract":"<p><strong>Background: </strong>Parkinson disease (PD) is a progressive neurodegenerative disorder characterized by motor dysfunctions and nonmotor symptoms. Current treatments do not alter disease progression, highlighting the need for alternative therapies. Music, dance, and mindfulness meditation have shown the potential to improve symptoms and quality of life in patients with PD.</p><p><strong>Objective: </strong>This study aims to evaluate the effectiveness of dance or music and meditation on PD progression, cognitive functions, mood, behavior, and caregiver burden.</p><p><strong>Methods: </strong>This study is a single-blinded, longitudinal, parallel, randomized controlled trial. The participants consist of 30 patients with mild to moderate PD residing in Mumbai, India, who can physically participate in the activities. The exclusion criteria include advanced PD, severe balance issues, age >80 years, and other movement disorders. Participants in the intervention group will engage in dance or music sessions and guided meditation thrice weekly for 6 months. The control group will continue their usual activities and medication. The primary outcome is the progression of PD symptoms, measured using the Unified Parkinson's Disease Rating Scale I-III, and quality of life, measured using the Parkinson's Disease Questionnaire-39. The secondary outcomes include cognitive functions (Mini-Mental State Examination), mood (Beck Depression Inventory and Parkinson Anxiety Scale), mobility (timed up and go and Berg Balance Test), behavioral disorders (Questionnaire for Impulsive-Compulsive Disorders in Parkinson's Disease Rating Scale), and caregiver burden (Zarit Burden Interview and Parkinson's Disease Questionnaire-Carer).</p><p><strong>Results: </strong>Data collection was completed in February 2024, with 28 participants finishing the study (intervention group: n=15, 54% and control group: n=13, 46%). Data analysis is underway, with results expected to be published in December 2024.</p><p><strong>Conclusions: </strong>This study aims to provide significant insights into the effectiveness of dance or music and meditation in improving the quality of life and slowing the progression of PD. The findings are anticipated to support using these nonpharmaceutical therapies as complementary approaches to managing PD.</p><p><strong>Trial registration: </strong>CTRI/2023/03/051064; https://tinyurl.com/2xdus53j.</p><p><strong>International registered report identifier (irrid): </strong>DERR1-10.2196/59018.</p>","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":null,"pages":null},"PeriodicalIF":1.4,"publicationDate":"2024-10-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142545589","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Diane Heels-Ansdell, Laurel Kelly, Heather K O'Grady, Christopher Farley, Julie C Reid, Sue Berney, Amy M Pastva, Karen Ea Burns, Frédérick D'Aragon, Margaret S Herridge, Andrew Seely, Jill Rudkowski, Bram Rochwerg, Alison Fox-Robichaud, Ian Ball, Francois Lamontagne, Erick H Duan, Jennifer Tsang, Patrick M Archambault, Avelino C Verceles, John Muscedere, Sangeeta Mehta, Shane W English, Tim Karachi, Karim Serri, Brenda Reeve, Lehana Thabane, Deborah Cook, Michelle E Kho
Background: Survivors of critical illness are at risk of developing physical dysfunction following intensive care unit (ICU) discharge. ICU-based rehabilitation interventions, such as early in-bed cycle ergometry, may improve patients' short-term physical function.
Objective: Before unblinding and trial database lock, we describe a prespecified statistical analysis plan (SAP) for the CYCLE (Critical Care Cycling to Improve Lower Extremity Strength) randomized controlled trial (RCT).
Methods: CYCLE is a 360-patient, international, multicenter, open-label, parallel-group RCT (1:1 ratio) with blinded primary outcome assessment at 3 days post-ICU discharge. The principal investigator and statisticians of CYCLE prepared this SAP with approval from the steering committee and coinvestigators. The SAP defines the primary and secondary outcomes (including adverse events) and describes the planned primary, secondary, and subgroup analyses. The primary outcome of the CYCLE trial is the Physical Function Intensive Care Unit Test-scored (PFIT-s) at 3 days post-ICU discharge. The PFIT-s is a reliable and valid performance-based measure. We plan to use a frequentist statistical framework for all analyses. We will conduct a linear regression to evaluate the primary outcome, incorporating randomization as an independent variable and adjusting for age (≥65 years versus <65 years) and center. The regression results will be reported as mean differences in PFIT-s scores with corresponding 95% CIs and P values. We consider a 1-point difference in PFIT-s score to be clinically important. Additionally, we plan to conduct 3 subgroup analyses: age (≥65 years versus <65 years), frailty (Baseline Clinical Frailty Scale ≥5 versus <5), and sex (male versus female).
Results: CYCLE was funded in 2017, and enrollment was completed in May 2023. Data analyses are complete, and the first results were submitted for publication in 2024.
Conclusions: We developed and present an SAP for the CYCLE RCT and will adhere to it for all analyses. This study will add to the growing body of evidence evaluating the efficacy and safety of ICU-based rehabilitation interventions.
Trial registration: ClinicalTrials.gov NCT03471247; https://clinicaltrials.gov/ct2/show/NCT03471247 and NCT02377830; https://clinicaltrials.gov/ct2/show/NCT02377830.
International registered report identifier (irrid): RR1-10.2196/54451.
{"title":"Early In-Bed Cycle Ergometry With Critically Ill, Mechanically Ventilated Patients: Statistical Analysis Plan for CYCLE (Critical Care Cycling to Improve Lower Extremity Strength), an International, Multicenter, Randomized Clinical Trial.","authors":"Diane Heels-Ansdell, Laurel Kelly, Heather K O'Grady, Christopher Farley, Julie C Reid, Sue Berney, Amy M Pastva, Karen Ea Burns, Frédérick D'Aragon, Margaret S Herridge, Andrew Seely, Jill Rudkowski, Bram Rochwerg, Alison Fox-Robichaud, Ian Ball, Francois Lamontagne, Erick H Duan, Jennifer Tsang, Patrick M Archambault, Avelino C Verceles, John Muscedere, Sangeeta Mehta, Shane W English, Tim Karachi, Karim Serri, Brenda Reeve, Lehana Thabane, Deborah Cook, Michelle E Kho","doi":"10.2196/54451","DOIUrl":"https://doi.org/10.2196/54451","url":null,"abstract":"<p><strong>Background: </strong>Survivors of critical illness are at risk of developing physical dysfunction following intensive care unit (ICU) discharge. ICU-based rehabilitation interventions, such as early in-bed cycle ergometry, may improve patients' short-term physical function.</p><p><strong>Objective: </strong>Before unblinding and trial database lock, we describe a prespecified statistical analysis plan (SAP) for the CYCLE (Critical Care Cycling to Improve Lower Extremity Strength) randomized controlled trial (RCT).</p><p><strong>Methods: </strong>CYCLE is a 360-patient, international, multicenter, open-label, parallel-group RCT (1:1 ratio) with blinded primary outcome assessment at 3 days post-ICU discharge. The principal investigator and statisticians of CYCLE prepared this SAP with approval from the steering committee and coinvestigators. The SAP defines the primary and secondary outcomes (including adverse events) and describes the planned primary, secondary, and subgroup analyses. The primary outcome of the CYCLE trial is the Physical Function Intensive Care Unit Test-scored (PFIT-s) at 3 days post-ICU discharge. The PFIT-s is a reliable and valid performance-based measure. We plan to use a frequentist statistical framework for all analyses. We will conduct a linear regression to evaluate the primary outcome, incorporating randomization as an independent variable and adjusting for age (≥65 years versus <65 years) and center. The regression results will be reported as mean differences in PFIT-s scores with corresponding 95% CIs and P values. We consider a 1-point difference in PFIT-s score to be clinically important. Additionally, we plan to conduct 3 subgroup analyses: age (≥65 years versus <65 years), frailty (Baseline Clinical Frailty Scale ≥5 versus <5), and sex (male versus female).</p><p><strong>Results: </strong>CYCLE was funded in 2017, and enrollment was completed in May 2023. Data analyses are complete, and the first results were submitted for publication in 2024.</p><p><strong>Conclusions: </strong>We developed and present an SAP for the CYCLE RCT and will adhere to it for all analyses. This study will add to the growing body of evidence evaluating the efficacy and safety of ICU-based rehabilitation interventions.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov NCT03471247; https://clinicaltrials.gov/ct2/show/NCT03471247 and NCT02377830; https://clinicaltrials.gov/ct2/show/NCT02377830.</p><p><strong>International registered report identifier (irrid): </strong>RR1-10.2196/54451.</p>","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":null,"pages":null},"PeriodicalIF":1.4,"publicationDate":"2024-10-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142521894","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Ga-Young Kim, Mini Jo, Young Sang Cho, Il Joon Moon
Background: With the aging of society, the prevalence of hearing loss (HL) is increasing. Currently, approximately 5% of the global population has HL, and this number is projected to reach 7 million by 2050. Although hearing aids (HAs) are the primary treatment for HL, their use is limited by barriers such as high costs and social stigma. To address these limitations, over-the-counter (OTC) HAs have been introduced, but their effectiveness and drawbacks require further investigation.
Objective: This study aims to conduct a noninferiority randomized controlled trial comparing OTC HAs with traditional HAs to assess the clinical effectiveness of OTC HAs.
Methods: We designed a noninferiority randomized controlled trial comparing OTC HAs and traditional HAs in adults with mild-to-moderate HL. A total of 64 participants (32 per group) will be recruited. Randomization will be performed using block randomization (block sizes of 2 or 4) with an equal allocation ratio. The study will include 2 types of HAs: an OTC HA (Jabra Enhance Pro) and a traditional HA (LiNX Quattro LE561-DRW) by GN ReSound A/S. OTC HAs will be self-fitted using a smartphone app, while traditional HAs will be fitted by a licensed audiologist using the National Acoustics Laboratories-Non-Linear Prescription, second generation. Assessments, including functional gain, real-ear measurement, speech audiometry, and questionnaires, will be conducted at 6-month intervals over the course of 3 visits. Statistical analysis will compare the 2 outcomes, focusing on functional gain, to determine noninferiority.
Results: This study is scheduled to begin in August 2024 and has not yet recruited any participants. The study will be conducted over 2 years, from August 2024 to July 2026. Each participant will have 2 follow-up visits at 6-month intervals, making the total follow-up period 1 year.
Conclusions: Since 2022, the introduction of OTC HAs has revolutionized access to these devices. Researchers, clinicians, and the general public are keen to evaluate the clinical effectiveness of OTC HAs, as more individuals will likely use them for HL. This increased usage will provide valuable real-world data to understand the benefits and limitations of OTC HAs. Monitoring the outcomes and user feedback will provide insights into their effectiveness and impact on hearing rehabilitation.
International registered report identifier (irrid): PRR1-10.2196/59894.
背景:随着社会老龄化的加剧,听力损失(HL)的发病率也在不断上升。目前,全球约有 5% 的人口患有听力损失,预计到 2050 年,这一数字将达到 700 万。虽然助听器(HAs)是治疗听力损失的主要方法,但其使用却受到高昂费用和社会偏见等障碍的限制。为了解决这些问题,人们开始使用非处方(OTC)助听器,但其有效性和缺点需要进一步调查:本研究旨在进行一项非劣效性随机对照试验,将非处方药 HA 与传统 HA 进行比较,以评估非处方药 HA 的临床有效性:我们设计了一项非劣效性随机对照试验,比较 OTC HA 和传统 HA 对轻度至中度 HL 成人的治疗效果。总共将招募 64 名参与者(每组 32 人)。随机分配将采用等分配比例的区组随机法(区组大小为 2 或 4)进行。研究将包括两种类型的助听器:一种是 OTC 助听器(Jabra Enhance Pro),另一种是 GN ReSound A/S 生产的传统助听器(LiNX Quattro LE561-DRW)。OTC 助听器将使用智能手机应用程序自行安装,而传统助听器将由持证听力学家使用美国国家声学实验室第二代非线性处方进行安装。评估包括功能增益、实耳测量、言语测听和问卷调查,将在 3 次就诊过程中每 6 个月进行一次。统计分析将比较两种结果,重点是功能增益,以确定非劣效性:该研究计划于 2024 年 8 月开始,目前尚未招募任何参与者。研究将从 2024 年 8 月至 2026 年 7 月进行,为期 2 年。每位参与者将每隔 6 个月进行 2 次随访,总随访期为 1 年:自 2022 年以来,非处方药 HAs 的推出彻底改变了人们对这些设备的使用。研究人员、临床医生和公众都热衷于评估非处方 HA 的临床效果,因为可能会有更多的人将其用于 HL。使用量的增加将为了解 OTC HAs 的优点和局限性提供宝贵的真实数据。监测结果和用户反馈将有助于深入了解它们对听力康复的有效性和影响:PRR1-10.2196/59894。
{"title":"Over-the-Counter Hearing Aids Versus Traditional Hearing Aids in Patients With Mild-to-Moderate Hearing Loss: Protocol for a Noninferiority Randomized Controlled Trial.","authors":"Ga-Young Kim, Mini Jo, Young Sang Cho, Il Joon Moon","doi":"10.2196/59894","DOIUrl":"https://doi.org/10.2196/59894","url":null,"abstract":"<p><strong>Background: </strong>With the aging of society, the prevalence of hearing loss (HL) is increasing. Currently, approximately 5% of the global population has HL, and this number is projected to reach 7 million by 2050. Although hearing aids (HAs) are the primary treatment for HL, their use is limited by barriers such as high costs and social stigma. To address these limitations, over-the-counter (OTC) HAs have been introduced, but their effectiveness and drawbacks require further investigation.</p><p><strong>Objective: </strong>This study aims to conduct a noninferiority randomized controlled trial comparing OTC HAs with traditional HAs to assess the clinical effectiveness of OTC HAs.</p><p><strong>Methods: </strong>We designed a noninferiority randomized controlled trial comparing OTC HAs and traditional HAs in adults with mild-to-moderate HL. A total of 64 participants (32 per group) will be recruited. Randomization will be performed using block randomization (block sizes of 2 or 4) with an equal allocation ratio. The study will include 2 types of HAs: an OTC HA (Jabra Enhance Pro) and a traditional HA (LiNX Quattro LE561-DRW) by GN ReSound A/S. OTC HAs will be self-fitted using a smartphone app, while traditional HAs will be fitted by a licensed audiologist using the National Acoustics Laboratories-Non-Linear Prescription, second generation. Assessments, including functional gain, real-ear measurement, speech audiometry, and questionnaires, will be conducted at 6-month intervals over the course of 3 visits. Statistical analysis will compare the 2 outcomes, focusing on functional gain, to determine noninferiority.</p><p><strong>Results: </strong>This study is scheduled to begin in August 2024 and has not yet recruited any participants. The study will be conducted over 2 years, from August 2024 to July 2026. Each participant will have 2 follow-up visits at 6-month intervals, making the total follow-up period 1 year.</p><p><strong>Conclusions: </strong>Since 2022, the introduction of OTC HAs has revolutionized access to these devices. Researchers, clinicians, and the general public are keen to evaluate the clinical effectiveness of OTC HAs, as more individuals will likely use them for HL. This increased usage will provide valuable real-world data to understand the benefits and limitations of OTC HAs. Monitoring the outcomes and user feedback will provide insights into their effectiveness and impact on hearing rehabilitation.</p><p><strong>International registered report identifier (irrid): </strong>PRR1-10.2196/59894.</p>","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":null,"pages":null},"PeriodicalIF":1.4,"publicationDate":"2024-10-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142500757","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Michelle R Rauzi, Rachael B Akay, Swapna Balakrishnan, Christi Piper, Denise Gobert, Alicia Flach
Background: Connected sensor technologies can capture raw data and analyze them using advanced statistical methods such as machine learning or artificial intelligence to generate interpretable behavioral or physiological outcomes. Previous research conducted on connected sensor technologies has focused on design, development, and validation. Published review studies have either summarized general technological solutions to address specific behaviors such as physical activity or focused on remote monitoring solutions in specific patient populations.
Objective: This study aimed to map research that focused on using connected sensor technologies to augment rehabilitation services by informing care decisions.
Methods: The Population, Concept, and Context framework will be used to define inclusion criteria. Relevant articles published between 2008 to the present will be included if (1) the study enrolled adults (population), (2) the intervention used at least one connected sensor technology and involved data transfer to a clinician so that the data could be used to inform the intervention (concept), and (3) the intervention was within the scope of rehabilitation (context). An initial search strategy will be built in Embase; peer reviewed; and then translated to Ovid MEDLINE ALL, Web of Science Core Collection, and CINAHL. Duplicates will be removed prior to screening articles for inclusion. Two independent reviewers will screen articles in 2 stages: title/abstract and full text. Discrepancies will be resolved through group discussion. Data from eligible articles relevant to population, concept, and context will be extracted. Descriptive statistics will be used to report findings, and relevant outcomes will include the type and frequency of connected sensor used and method of data sharing. Additional details will be narratively summarized and displayed in tables and figures. Key partners will review results to enhance interpretation and trustworthiness.
Results: We conducted initial searches to refine the search strategy in February 2024. The results of this scoping review are expected in October 2024.
Conclusions: Results from the scoping review will identify critical areas of inquiry to advance the field of technology-augmented rehabilitation. Results will also support the development of a longitudinal model to support long-term health outcomes.
Trial registration: Open Science Framework jys53; https://osf.io/jys53.
International registered report identifier (irrid): DERR1-10.2196/60496.
{"title":"Current State of Connected Sensor Technologies Used During Rehabilitation Care: Protocol for a Scoping Review.","authors":"Michelle R Rauzi, Rachael B Akay, Swapna Balakrishnan, Christi Piper, Denise Gobert, Alicia Flach","doi":"10.2196/60496","DOIUrl":"10.2196/60496","url":null,"abstract":"<p><strong>Background: </strong>Connected sensor technologies can capture raw data and analyze them using advanced statistical methods such as machine learning or artificial intelligence to generate interpretable behavioral or physiological outcomes. Previous research conducted on connected sensor technologies has focused on design, development, and validation. Published review studies have either summarized general technological solutions to address specific behaviors such as physical activity or focused on remote monitoring solutions in specific patient populations.</p><p><strong>Objective: </strong>This study aimed to map research that focused on using connected sensor technologies to augment rehabilitation services by informing care decisions.</p><p><strong>Methods: </strong>The Population, Concept, and Context framework will be used to define inclusion criteria. Relevant articles published between 2008 to the present will be included if (1) the study enrolled adults (population), (2) the intervention used at least one connected sensor technology and involved data transfer to a clinician so that the data could be used to inform the intervention (concept), and (3) the intervention was within the scope of rehabilitation (context). An initial search strategy will be built in Embase; peer reviewed; and then translated to Ovid MEDLINE ALL, Web of Science Core Collection, and CINAHL. Duplicates will be removed prior to screening articles for inclusion. Two independent reviewers will screen articles in 2 stages: title/abstract and full text. Discrepancies will be resolved through group discussion. Data from eligible articles relevant to population, concept, and context will be extracted. Descriptive statistics will be used to report findings, and relevant outcomes will include the type and frequency of connected sensor used and method of data sharing. Additional details will be narratively summarized and displayed in tables and figures. Key partners will review results to enhance interpretation and trustworthiness.</p><p><strong>Results: </strong>We conducted initial searches to refine the search strategy in February 2024. The results of this scoping review are expected in October 2024.</p><p><strong>Conclusions: </strong>Results from the scoping review will identify critical areas of inquiry to advance the field of technology-augmented rehabilitation. Results will also support the development of a longitudinal model to support long-term health outcomes.</p><p><strong>Trial registration: </strong>Open Science Framework jys53; https://osf.io/jys53.</p><p><strong>International registered report identifier (irrid): </strong>DERR1-10.2196/60496.</p>","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":null,"pages":null},"PeriodicalIF":1.4,"publicationDate":"2024-10-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142500754","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Ingrid Kvestad, Frode Adolfsen, Renira Corinne Angeles, Oda Lekve Brandseth, Kyrre Breivik, Janne Grete Evertsen, Irene Kvåle Foer, Morten Haaland, Birgit Millerjord Homola, Gro Elisabeth Hoseth, Josefine Jonsson, Egil Kjerstad, Henriette Kyrrestad, Monica Martinussen, Annelene Moberg, Karianne Moberg, Anita Skogstrand, Line Remme Solberg, Merete Aasheim
Background: A new and growing body of research has studied bullying among children in early childhood education and care centers (ECECs). The Bernese Program (Be-Prox) is designed to systematically prevent and handle bullying between children in Swiss ECECs. However, the effectiveness of the Be-Prox intervention has not yet been explored in a Norwegian ECEC setting.
Objective: This study aims to evaluate the effectiveness of Be-Prox in preventing and handling bullying among peers in Norwegian ECECs.
Methods: ECECs from 2 Norwegian municipalities were invited to participate in a cluster randomized controlled trial (RCT) to evaluate the effectiveness of the Be-Prox intervention on peer bullying in Norwegian ECECs. After baseline measures were taken, project ECECs were randomized to either an intervention or a control arm. The Be-Prox intervention was introduced to ECECs in the intervention arm through 6 modules over a 9-month period immediately after the randomization. ECECs in the control arm participated in the data collection and were offered the Be-Prox intervention the following year. The primary outcome of the effect evaluation is the mean sum of negative behavior between peers after the Be-Prox training is completed in the intervention arm. Secondary outcomes include child bystander behavior, teacher self-efficacy, and ECEC's authoritative climate. An extensive implementation and process evaluation, as well as cost-effectiveness analyses, will be conducted alongside the RCT.
Results: Baseline data collection was conducted in September 2023, and the postintervention data collection started in May 2024. At baseline, we collected data on 708 children and 413 personnel from 38 project ECECs in the 2 Norwegian municipalities. The results from the study will be available in late 2024 at the earliest.
Conclusions: The proposed project includes a comprehensive evaluation of the effectiveness of Be-Prox in Norwegian ECECs directly targeting the prevention and handling of bullying, including implementation and cost-effectiveness evaluations. The results from the project have the potential to fill in identified knowledge gaps in the understanding of negative behavior and bullying between peers in ECECs, and how these may be prevented. If proven efficient, our ambition is to offer Be-Prox to Norwegian ECECs as an evidence-based practice to prevent and handle bullying among preschool children.
{"title":"Effectiveness of a Bullying Intervention (Be-Prox) in Norwegian Early Childhood and Education Care Centers: Protocol for a Cluster Randomized Controlled Trial.","authors":"Ingrid Kvestad, Frode Adolfsen, Renira Corinne Angeles, Oda Lekve Brandseth, Kyrre Breivik, Janne Grete Evertsen, Irene Kvåle Foer, Morten Haaland, Birgit Millerjord Homola, Gro Elisabeth Hoseth, Josefine Jonsson, Egil Kjerstad, Henriette Kyrrestad, Monica Martinussen, Annelene Moberg, Karianne Moberg, Anita Skogstrand, Line Remme Solberg, Merete Aasheim","doi":"10.2196/60626","DOIUrl":"https://doi.org/10.2196/60626","url":null,"abstract":"<p><strong>Background: </strong>A new and growing body of research has studied bullying among children in early childhood education and care centers (ECECs). The Bernese Program (Be-Prox) is designed to systematically prevent and handle bullying between children in Swiss ECECs. However, the effectiveness of the Be-Prox intervention has not yet been explored in a Norwegian ECEC setting.</p><p><strong>Objective: </strong>This study aims to evaluate the effectiveness of Be-Prox in preventing and handling bullying among peers in Norwegian ECECs.</p><p><strong>Methods: </strong>ECECs from 2 Norwegian municipalities were invited to participate in a cluster randomized controlled trial (RCT) to evaluate the effectiveness of the Be-Prox intervention on peer bullying in Norwegian ECECs. After baseline measures were taken, project ECECs were randomized to either an intervention or a control arm. The Be-Prox intervention was introduced to ECECs in the intervention arm through 6 modules over a 9-month period immediately after the randomization. ECECs in the control arm participated in the data collection and were offered the Be-Prox intervention the following year. The primary outcome of the effect evaluation is the mean sum of negative behavior between peers after the Be-Prox training is completed in the intervention arm. Secondary outcomes include child bystander behavior, teacher self-efficacy, and ECEC's authoritative climate. An extensive implementation and process evaluation, as well as cost-effectiveness analyses, will be conducted alongside the RCT.</p><p><strong>Results: </strong>Baseline data collection was conducted in September 2023, and the postintervention data collection started in May 2024. At baseline, we collected data on 708 children and 413 personnel from 38 project ECECs in the 2 Norwegian municipalities. The results from the study will be available in late 2024 at the earliest.</p><p><strong>Conclusions: </strong>The proposed project includes a comprehensive evaluation of the effectiveness of Be-Prox in Norwegian ECECs directly targeting the prevention and handling of bullying, including implementation and cost-effectiveness evaluations. The results from the project have the potential to fill in identified knowledge gaps in the understanding of negative behavior and bullying between peers in ECECs, and how these may be prevented. If proven efficient, our ambition is to offer Be-Prox to Norwegian ECECs as an evidence-based practice to prevent and handle bullying among preschool children.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov NCT06040437; https://clinicaltrials.gov/study/NCT06040437.</p><p><strong>International registered report identifier (irrid): </strong>DERR1-10.2196/60626.</p>","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":null,"pages":null},"PeriodicalIF":1.4,"publicationDate":"2024-10-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142500755","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Rahel Pearson, Christopher G Beevers, Joseph Mignogna, Justin Benzer, Paul N Pfeiffer, Edward Post, Suzannah K Creech
Background: Depressive symptoms are common in veterans, and the presence of these symptoms increases disability as well as suicidal thoughts and behaviors. However, there is evidence that these symptoms often go untreated. Intervening before symptoms become severe and entrenched is related to better long-term outcomes, including improved functioning and less disease chronicity. Computer-delivered interventions may be especially appropriate for those veterans with mild to moderate depressive symptoms, because these interventions can require fewer resources and have lower barriers to access and thus have potential for wider reach. Despite this potential, there is a dearth of research examining computerized interventions for depressive symptoms in veteran samples.
Objective: The aim of this study is to evaluate the efficacy of Deprexis (GAIA AG), a computerized intervention for depressive symptoms and related functional impairment.
Methods: Veterans will be recruited through the US Department of Veterans Affairs electronic medical record and through primary care and specialty clinics. First, qualitative interviews will be completed with a small subset of veterans (n=16-20) to assess the acceptability of treatment procedures. Next, veterans (n=132) with mild to moderate depressive symptoms will be randomly assigned to the fully automated Deprexis intervention or a treatment-as-usual control group. The primary outcomes will be self-reported depressive symptoms and various dimensions of psychosocial functioning.
Results: This project was funded in May 2024, and data collection will be conducted between October 2024 and April 2029. Overall, 4 participants have been recruited as of the submission of the manuscript, and data analysis is expected in June 2029, with initial results expected in November 2029.
Conclusions: This study will provide initial evidence for the efficacy of self-guided, computerized interventions for depressive symptoms and functional impairment in veterans. If effective, these types of interventions could improve veteran access to low-resource psychosocial treatments.
{"title":"The Evaluation of a Web-Based Intervention (Deprexis) to Decrease Depression and Restore Functioning in Veterans: Protocol for a Randomized Controlled Trial.","authors":"Rahel Pearson, Christopher G Beevers, Joseph Mignogna, Justin Benzer, Paul N Pfeiffer, Edward Post, Suzannah K Creech","doi":"10.2196/59119","DOIUrl":"10.2196/59119","url":null,"abstract":"<p><strong>Background: </strong>Depressive symptoms are common in veterans, and the presence of these symptoms increases disability as well as suicidal thoughts and behaviors. However, there is evidence that these symptoms often go untreated. Intervening before symptoms become severe and entrenched is related to better long-term outcomes, including improved functioning and less disease chronicity. Computer-delivered interventions may be especially appropriate for those veterans with mild to moderate depressive symptoms, because these interventions can require fewer resources and have lower barriers to access and thus have potential for wider reach. Despite this potential, there is a dearth of research examining computerized interventions for depressive symptoms in veteran samples.</p><p><strong>Objective: </strong>The aim of this study is to evaluate the efficacy of Deprexis (GAIA AG), a computerized intervention for depressive symptoms and related functional impairment.</p><p><strong>Methods: </strong>Veterans will be recruited through the US Department of Veterans Affairs electronic medical record and through primary care and specialty clinics. First, qualitative interviews will be completed with a small subset of veterans (n=16-20) to assess the acceptability of treatment procedures. Next, veterans (n=132) with mild to moderate depressive symptoms will be randomly assigned to the fully automated Deprexis intervention or a treatment-as-usual control group. The primary outcomes will be self-reported depressive symptoms and various dimensions of psychosocial functioning.</p><p><strong>Results: </strong>This project was funded in May 2024, and data collection will be conducted between October 2024 and April 2029. Overall, 4 participants have been recruited as of the submission of the manuscript, and data analysis is expected in June 2029, with initial results expected in November 2029.</p><p><strong>Conclusions: </strong>This study will provide initial evidence for the efficacy of self-guided, computerized interventions for depressive symptoms and functional impairment in veterans. If effective, these types of interventions could improve veteran access to low-resource psychosocial treatments.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov NCT06217198; https://www.clinicaltrials.gov/study/NCT06217198.</p><p><strong>International registered report identifier (irrid): </strong>PRR1-10.2196/59119.</p>","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":null,"pages":null},"PeriodicalIF":1.4,"publicationDate":"2024-10-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142500758","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}