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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. 富含香料和草药的高钾饮食-盐替代物(HPSH-SS)用于降低老年人血压:饮食概念和随机对照试验方案》。
IF 1.4 Q3 HEALTH CARE SCIENCES & SERVICES Pub Date : 2024-10-29 DOI: 10.2196/56869
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.

背景:高血压会随着年龄的增长而增加,这通常是由于钠(Na)摄入量高而钾(K)摄入量低造成的。减少盐和增加钾的摄入量具有挑战性,尤其是对老年人来说,这与口味偏好有关。富含钾的烹饪草药和香料提供了一个潜在的解决方案。富含香料和草药的高钾饮食-盐替代(HPSH-SS)饮食在降低血压方面的有效性尚未得到研究:本研究旨在创建一种 HPSH-SS 饮食,分析其对老年人血压的影响,并研究这种饮食影响肾脏和血管的分子机制:本研究包括两个阶段。第一阶段包括制定和评估为老年人量身定制的 HPSH-SS 饮食。干预组(IG)每天摄入 1800 千卡热量、3500 毫克钾和 1500 毫克钠,对照组(CG)每天摄入 1500 毫克钾和 2000 毫克钠。饮食管理为期 14 天,并使用营养调查程序和原子吸收分光光度法(AAS)进行生化分析。第二阶段是为期 14 天的平行随机对照试验(RCT),老年参与者分为 IG 和 CG 两组。主要结果包括血压、血清钾、醛固酮、F2 异前列腺素、一氧化氮血浆水平以及尿液中的钠、钾和 Na/K 比值分析。通过随机化和分层分析控制了干扰变量:HPSH-SS饮食的菜单制定和感官评估始于2022年年中,并于2022年5月11日获得Airlangga大学公共卫生学院伦理委员会的批准(78/EA/KEPK/2022)。该饮食经过标准化,每日营养值为 1800 千卡能量、3500 毫克钾和 1500 毫克钠。利用几位参与者的香料饮食菜单中的 AAS 分析了 K 和 Na 的含量。经泗水艾尔朗加大学医学院健康研究伦理委员会批准(35/EC/KEPK/FKUA/2023),RCT 的招募工作于 2023 年 3 月开始。研究登记时间为 2023 年 2 月 9 日至 2024 年 2 月 9 日。2023 年 3 月至 6 月期间,共招募了 64 名参与者,其中 IG 和 CG 各 32 人。干预和数据收集将历时 1 年。数据管理正在进行中,数据分析尚未进行:该 RCT 方案假设,饮食将增加血清 K、血浆醛固酮和一氧化氮水平;降低血浆 F2 异前列腺素;增加尿液 Na 和 K 水平;降低尿液 Na/K 比率;降低收缩压和舒张压。如果有效,它将为老年人调节血压的饮食策略提供有价值的见解:DERR1-10.2196/56869。
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引用次数: 0
Correction: Outcomes of Patients With Early and Locally Advanced Lung Cancer: Protocol for the Italian Lung Cancer Observational Study (LUCENT). 更正:早期和局部晚期肺癌患者的疗效:意大利肺癌观察研究(LUCENT)协议书。
IF 1.4 Q3 HEALTH CARE SCIENCES & SERVICES Pub Date : 2024-10-29 DOI: 10.2196/67629
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]。
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引用次数: 0
Virtual Hospitals and Patient Experience: Protocol for a Mixed Methods Observational Study. 虚拟医院与患者体验:混合方法观察研究协议》。
IF 1.4 Q3 HEALTH CARE SCIENCES & SERVICES Pub Date : 2024-10-29 DOI: 10.2196/58683
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.

背景:虚拟医疗越来越多地被纳入常规医疗机构,以改善患者体验和获得医疗服务的机会。病人的体验包括个人与医疗保健系统的所有互动。这包括更加重视让护理者积极参与围绕患者医疗保健的决策和活动:本研究旨在调查在虚拟医院中遇到的各种医疗服务挑战,并探索改善患者体验的潜在方法:本协议概述了一项混合方法研究,以急性呼吸系统为重点,探讨澳大利亚一家虚拟医院--阿尔弗雷德皇家王子虚拟医院(rpavirtual)的患者体验。我们将采用探索性混合方法,包括二手数据分析、观察、访谈和共同设计焦点小组。参与者将包括参与急性呼吸系统虚拟医院护理模式的患者、护理人员和医护人员。我们将对这些数据进行三角测量,以探讨使用这种护理模式的观点和经验,并共同设计进一步改进的建议:这项研究的结果将确定目前实施虚拟护理的障碍和促进因素,如虚拟护理过程中的 "完成工作 "与 "想象工作"、护理公平性、护理人员的角色和患者安全。截至 2024 年 8 月,共对 25 名参与者进行了访谈:本协议概述了一项关于澳大利亚首家虚拟医院 rpavirtual 的急性呼吸系统护理模式的混合方法案例研究。这项研究将收集患者、护理人员和医护人员的经验,共同设计一系列建议,以改善患者的就医体验:DERR1-10.2196/58683。
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引用次数: 0
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. 为产后抑郁高风险人群量身定制的产后电子健康体育活动干预--产后健康研究(POW):随机对照试验的方案和数据概述。
IF 1.4 Q3 HEALTH CARE SCIENCES & SERVICES Pub Date : 2024-10-29 DOI: 10.2196/56882
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
背景:产后抑郁症(PPD)会对父母和孩子的健康造成严重影响。目前预防产后抑郁症的建议需要大量的医疗保健系统资源。我们需要以证据为基础的干预措施来预防产后抑郁症,同时又不会进一步加重医疗保健系统的负担。有证据表明,体育活动(PA)通常可以减轻抑郁症状。基于技术的干预措施可能有助于减少体育锻炼的常见障碍:本研究旨在报告 "产后健康研究"(POstpartum Wellness study,POW)的方案并提供数据概览。该研究是一项有效性试验,旨在评估为产后人群量身定制的电子健康 PA 干预是否能增加 PA 并减轻 PPD 高危人群的抑郁症状:这项远程平行分组随机对照试验的参与者包括有抑郁症病史或目前至少有中度抑郁症状但未达到 PPD 诊断标准且 PA 水平较低的产后人士,他们来自一个综合医疗保健服务系统。参与者被随机分配到电子健康 PA 干预组或常规护理组。干预组可以访问专为产后人士设计的网络锻炼视频库,其中包括与婴儿的互动。在基线和随访(3 个月和 6 个月)期间,使用调查问卷和腕戴式加速度计对 PA 进行测量。抑郁症状采用患者健康问卷-8(PHQ-8)进行测量。收集的数据用于评估睡眠、感知压力、焦虑、亲子关系和婴儿发育等探索性结果:该研究于 2020 年 1 月获得资助。参与者在 2020 年 11 月至 2022 年 9 月期间通过 REDCap(研究电子数据采集)或电话报名;数据收集于 2023 年 4 月结束。随机参与者(N=99)基线为产后 4 个月,有中度严重抑郁症状(PHQ-8 平均得分为 12.6,SD 为 2.2)。干预组(人数=50)和常规护理组(人数=49)的社会人口特征、产后月数、基线抑郁症状、家中孩子数量和孕前 PA 水平相似。问卷调查的保留率≥66%,加速度测量的保留率≥48%,各组之间差异不大。在 3 个月的随访中,99 名参与者中有 73 人(74%)完成了问卷调查(干预组:35/50,70%;常规护理组:38/49,78%);99 人中有 53 人(54%)佩戴了 7 天的加速度计(干预组:50 人中有 27 人(54%);常规护理组:49 人中有 26 人(53%))。在为期 6 个月的随访中,99 名参与者中有 66 名(67%)完成了问卷调查(50 名参与者中有 30 名(60%)接受了干预,49 名参与者中有 36 名(73%)接受了常规护理),99 名参与者中有 43 名(43%)连续 7 天佩戴加速度计(50 名参与者中有 21 名(42%)接受了干预,49 名参与者中有 22 名(45%)接受了常规护理)。数据分析已经完成,包含这些研究结果的手稿目前正在审核出版中:POW 试验评估了电子健康 PA 干预对改善抑郁症状和增加 PPD 高危产后人群 PA 的有效性。试验结果对弱势患者行为干预措施的设计和实施具有指导意义:ClinicalTrials.gov NCT04414696; https://clinicaltrials.gov/ct2/show/NCT04414696.International 注册报告标识符 (irrid):DERR1-10.2196/56882。
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引用次数: 0
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. 舞蹈或音乐与冥想对轻度或中度帕金森病进展的影响:随机对照试验方案》。
IF 1.4 Q3 HEALTH CARE SCIENCES & SERVICES Pub Date : 2024-10-29 DOI: 10.2196/59018
Bhagyashree Mehrotra, Neha Rai, Rajani Mr, Aparna Budhakar, Ritika Aggarwal, Raj Vinodkumar Agarbattiwala, Mona Thomas, Sampada Patole, Paresh Doshi

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.

Trial registration: CTRI/2023/03/051064; https://tinyurl.com/2xdus53j.

International registered report identifier (irrid): DERR1-10.2196/59018.

背景:帕金森病(PD)是一种进行性神经退行性疾病,以运动功能障碍和非运动症状为特征。目前的治疗方法无法改变疾病的进展,因此需要替代疗法。音乐、舞蹈和正念冥想已显示出改善帕金森病患者症状和生活质量的潜力:本研究旨在评估舞蹈、音乐和冥想对帕金森病进展、认知功能、情绪、行为和护理负担的影响:本研究是一项单盲、纵向、平行、随机对照试验。参与者包括 30 名居住在印度孟买的轻度至中度帕金森病患者,他们都可以参加活动。排除标准包括晚期帕金森病、严重平衡问题、年龄大于 80 岁以及其他运动障碍。干预组的参与者将参加舞蹈或音乐课程以及冥想指导,每周三次,为期 6 个月。对照组将继续其常规活动和药物治疗。主要结果是帕金森病症状的进展(使用帕金森病统一评定量表 I-III 进行测量)和生活质量(使用帕金森病问卷-39 进行测量)。次要结果包括认知功能(迷你精神状态检查)、情绪(贝克抑郁量表和帕金森焦虑量表)、行动能力(定时起立和走动和伯格平衡测试)、行为障碍(帕金森病冲动-强迫障碍评定量表问卷)和照顾者负担(Zarit负担访谈和帕金森病问卷-照顾者):数据收集工作已于 2024 年 2 月完成,28 名参与者完成了研究(干预组:15 人,占 54%;对照组:13 人,占 46%)。目前正在进行数据分析,预计将于 2024 年 12 月公布结果:本研究旨在就舞蹈、音乐和冥想在提高生活质量和减缓帕金森病进展方面的有效性提供重要见解。预计研究结果将支持使用这些非药物疗法作为控制帕金森病的辅助方法:CTRI/2023/03/051064;https://tinyurl.com/2xdus53j.International 注册报告标识符 (irrid):DERR1-10.2196/59018。
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引用次数: 0
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. 对机械通气的重症患者进行早期床上自行车负重训练:国际多中心随机临床试验 CYCLE(危重症患者骑自行车提高下肢力量)的统计分析计划。
IF 1.4 Q3 HEALTH CARE SCIENCES & SERVICES Pub Date : 2024-10-28 DOI: 10.2196/54451
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.

背景:危重病幸存者在重症监护室(ICU)出院后有可能出现身体功能障碍。以重症监护室为基础的康复干预措施,如早期床内循环测力,可改善患者的短期身体功能:在解除盲法和试验数据库锁定之前,我们介绍了 CYCLE(重症监护室骑自行车提高下肢力量)随机对照试验(RCT)的预设统计分析计划(SAP):CYCLE 是一项由 360 名患者参与的国际多中心、开放标签、平行组 RCT(1:1 比例),在重症监护室出院后 3 天进行主要结果盲法评估。CYCLE 的主要研究人员和统计人员在获得指导委员会和共同研究人员的批准后编写了本 SAP。SAP 定义了主要和次要结局(包括不良事件),并描述了计划进行的主要、次要和亚组分析。CYCLE 试验的主要结果是重症监护病房出院后 3 天的身体功能重症监护病房测试评分(PFIT-s)。PFIT-s 是一种可靠有效的基于表现的测量方法。我们计划使用频数统计框架进行所有分析。我们将进行线性回归来评估主要结果,将随机化作为自变量,并对年龄(≥65 岁与结果)进行调整:CYCLE 于 2017 年获得资助,并于 2023 年 5 月完成注册。数据分析已经完成,首批结果已于 2024 年提交发表:我们为 CYCLE RCT 制定并提出了 SAP,并将在所有分析中遵循该 SAP。这项研究将为越来越多的评估基于重症监护室的康复干预措施的有效性和安全性的证据增添新的内容:ClinicalTrials.gov NCT03471247; https://clinicaltrials.gov/ct2/show/NCT03471247 和 NCT02377830; https://clinicaltrials.gov/ct2/show/NCT02377830.International 注册报告标识符 (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}
引用次数: 0
Over-the-Counter Hearing Aids Versus Traditional Hearing Aids in Patients With Mild-to-Moderate Hearing Loss: Protocol for a Noninferiority Randomized Controlled Trial. 轻度至中度听力损失患者使用非处方助听器与传统助听器的对比:非劣效随机对照试验方案。
IF 1.4 Q3 HEALTH CARE SCIENCES & SERVICES Pub Date : 2024-10-25 DOI: 10.2196/59894
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。
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引用次数: 0
Current State of Connected Sensor Technologies Used During Rehabilitation Care: Protocol for a Scoping Review. 康复护理期间使用的互联传感器技术现状:范围审查协议》。
IF 1.4 Q3 HEALTH CARE SCIENCES & SERVICES Pub Date : 2024-10-24 DOI: 10.2196/60496
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.

背景:互联传感器技术可以捕捉原始数据,并利用机器学习或人工智能等先进的统计方法对其进行分析,从而生成可解释的行为或生理结果。以往对互联传感器技术的研究主要集中在设计、开发和验证方面。已发表的综述研究要么总结了针对特定行为(如体育锻炼)的通用技术解决方案,要么侧重于特定患者群体的远程监控解决方案:本研究旨在绘制一份研究地图,该地图侧重于使用互联传感器技术,通过为护理决策提供信息来增强康复服务:方法:将使用 "人群、概念和背景 "框架来定义纳入标准。2008年至今发表的相关文章将被纳入,条件是:(1)研究对象为成年人(人群);(2)干预措施至少使用了一种互联传感器技术,并涉及将数据传输给临床医生,以便利用这些数据为干预措施提供信息(概念);(3)干预措施属于康复范畴(背景)。将在 Embase 中建立初步搜索策略;同行评审;然后翻译成 Ovid MEDLINE ALL、Web of Science Core Collection 和 CINAHL。在筛选纳入文章之前,将删除重复的文章。两名独立审稿人将分两个阶段筛选文章:标题/摘要和全文。不一致之处将通过小组讨论解决。将从符合条件的文章中提取与人群、概念和背景相关的数据。将使用描述性统计来报告研究结果,相关结果将包括所使用的连接传感器的类型和频率以及数据共享的方法。其他详细信息将以叙述的方式进行总结,并以表格和图表的形式展示。主要合作伙伴将对结果进行审核,以加强解释和可信度:我们于 2024 年 2 月进行了初步搜索,以完善搜索策略。此次范围界定审查的结果预计将于 2024 年 10 月公布:范围界定审查的结果将确定关键的研究领域,以推动技术辅助康复领域的发展。审查结果还将支持开发一个纵向模型,以支持长期的健康成果:开放科学框架 jys53;https://osf.io/jys53.International 注册报告标识符 (irrid):DERR1-10.2196/60496.
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引用次数: 0
Effectiveness of a Bullying Intervention (Be-Prox) in Norwegian Early Childhood and Education Care Centers: Protocol for a Cluster Randomized Controlled Trial. 挪威幼儿和教育护理中心欺凌干预措施(Be-Prox)的效果:集群随机对照试验方案》。
IF 1.4 Q3 HEALTH CARE SCIENCES & SERVICES Pub Date : 2024-10-24 DOI: 10.2196/60626
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.

Trial registration: ClinicalTrials.gov NCT06040437; https://clinicaltrials.gov/study/NCT06040437.

International registered report identifier (irrid): DERR1-10.2196/60626.

背景:对儿童早期教育和保育中心(ECECs)中儿童之间的欺凌行为进行研究的新成果越来越多。伯尔尼计划(Be-Prox)旨在系统地预防和处理瑞士幼儿教育和保育中心儿童之间的欺凌行为。然而,Be-Prox干预措施在挪威幼儿保育和教育中心环境中的有效性尚未得到探讨:本研究旨在评估Be-Prox在挪威幼儿保育和教育中心预防和处理同伴间欺凌行为的有效性:挪威2个城市的幼儿保育和教育中心受邀参加了一项分组随机对照试验(RCT),以评估Be-Prox干预措施对挪威幼儿保育和教育中心同伴间欺凌行为的有效性。在进行基线测量后,项目中的幼儿保育和教育中心被随机分配到干预组或对照组。在随机分组后的9个月内,Be-Prox干预措施通过6个模块介绍给干预组的幼儿保育和教育中心。对照组的幼儿保育和教育机构参与数据收集,并在第二年接受 Be-Prox 干预方案。效果评估的主要结果是干预组完成 Be-Prox 培训后同伴间负面行为的平均总和。次要结果包括儿童旁观者行为、教师自我效能感和幼儿保育和教育中心的权威氛围。在进行 RCT 研究的同时,还将进行广泛的实施和过程评估以及成本效益分析:基线数据收集于 2023 年 9 月进行,干预后数据收集于 2024 年 5 月开始。在基线阶段,我们收集了挪威 2 个城市 38 个项目幼儿保育和教育中心的 708 名儿童和 413 名工作人员的数据。研究结果最早将于 2024 年底公布:拟议的项目包括对Be-Prox在挪威幼儿保育和教育中心直接预防和处理欺凌行为的效果进行全面评估,包括实施情况和成本效益评估。该项目的成果有可能填补在了解幼儿保育和教育中心同伴之间的负面行为和欺凌行为以及如何预防这些行为方面的知识空白。如果证明有效,我们的目标是向挪威的幼儿保育和教育机构提供Be-Prox,作为预防和处理学龄前儿童欺凌行为的循证做法:试验注册:ClinicalTrials.gov NCT06040437;https://clinicaltrials.gov/study/NCT06040437.International 注册报告标识符(irrid):DERR1-10.2196/60626。
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引用次数: 0
The Evaluation of a Web-Based Intervention (Deprexis) to Decrease Depression and Restore Functioning in Veterans: Protocol for a Randomized Controlled Trial. 评估基于网络的干预措施(Deprexis),以减轻退伍军人的抑郁情绪并恢复其功能:随机对照试验协议》。
IF 1.4 Q3 HEALTH CARE SCIENCES & SERVICES Pub Date : 2024-10-24 DOI: 10.2196/59119
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.

Trial registration: ClinicalTrials.gov NCT06217198; https://www.clinicaltrials.gov/study/NCT06217198.

International registered report identifier (irrid): PRR1-10.2196/59119.

背景:抑郁症状在退伍军人中很常见,这些症状的存在会增加残疾以及自杀念头和行为。然而,有证据表明,这些症状往往得不到治疗。在症状变得严重和根深蒂固之前进行干预与更好的长期治疗效果有关,包括改善功能和减少疾病的慢性化。计算机提供的干预措施可能特别适合那些有轻度至中度抑郁症状的退伍军人,因为这些干预措施所需的资源较少,获得的障碍较低,因此有可能扩大覆盖范围。尽管有这样的潜力,但针对退伍军人样本中抑郁症状的计算机化干预措施的研究还很缺乏:本研究旨在评估Deprexis(GAIA AG)的疗效,这是一种针对抑郁症状和相关功能障碍的计算机化干预方法:退伍军人将通过美国退伍军人事务部的电子病历以及初级保健和专科诊所招募。首先,将对一小部分退伍军人(人数=16-20)进行定性访谈,以评估治疗程序的可接受性。接下来,有轻度至中度抑郁症状的退伍军人(人数=132)将被随机分配到全自动Deprexis干预组或照常治疗对照组。主要结果将是自我报告的抑郁症状和社会心理功能的各个方面:该项目于 2024 年 5 月获得资助,数据收集工作将在 2024 年 10 月至 2029 年 4 月期间进行。截至稿件提交时,共招募了 4 名参与者,预计将于 2029 年 6 月进行数据分析,并于 2029 年 11 月得出初步结果:本研究将为计算机化自我指导干预对退伍军人抑郁症状和功能障碍的疗效提供初步证据。如果效果显著,这类干预措施可以改善退伍军人获得低资源社会心理治疗的机会:试验注册:ClinicalTrials.gov NCT06217198;https://www.clinicaltrials.gov/study/NCT06217198.International 注册报告标识符 (irrid):PRR1-10.2196/59119。
{"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}
引用次数: 0
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