Pub Date : 2025-02-01DOI: 10.1016/j.conctc.2024.101397
Reyna Jazmín Martínez-Arriaga , Alejandro Dominguez-Rodriguez , Sergio Osvaldo Meza-Chavolla , Yineth Alejandra Muñoz-Anacona , Adrián Antonio Cisneros-Hernández , Joel Omar González-Cantero , Leivy Patricia González-Ramírez , Paulina Erika Herdoiza-Arroyo , Norma Alicia Ruvalcaba-Romero , Fabiola Macías-Espinoza , Said Jiménez
Background
Some of the key challenges during the breast cancer diagnosis process include a lack of information and negative psychological consequences, such as distress and anxiety about the process. Implementing a psychoeducational program during the diagnosis process may enhance the well-being of women. “Salud Mamaria” is an Internet-Based Psychoeducational Program (IBPP) that comprises three interventions: A (“Improving Your Health Habits and Self-Care”), B (“Waiting for the Result of Your Biopsy”), and C (“Supporting You After Your Breast Cancer Diagnosis”).
Objective
1) To evaluate changes in the study variables following each of the three interventions (A, B, and C), and 2) To assess the differences in study variables between the IBPP and an active control group.
Methods
This is a superiority trial employing an experimental design with two independent groups: an experimental group and an active control group. All participants will be randomized to one of the two conditions. Anxiety symptoms, negative screening of consequences, sense of coherence, satisfaction with the intervention, and system usability will be measured. Patients will be assigned to an intervention based on their clinical situation: without cancer suspicion (A), with cancer suspicion (B), or diagnosed with cancer (C). Questionnaires will be administered via the online platform before and after each intervention.
Conclusions
A psychoeducational program implemented during the breast cancer screening and diagnosis process may promote the health and well-being of women. It may also encourage adherence to medical screening recommendations, mitigating the lack of information and reducing associated distress.
{"title":"“Salud Mamaria”, an internet-based psychoeducational program during the breast cancer diagnosis process: Protocol for a randomized controlled trial","authors":"Reyna Jazmín Martínez-Arriaga , Alejandro Dominguez-Rodriguez , Sergio Osvaldo Meza-Chavolla , Yineth Alejandra Muñoz-Anacona , Adrián Antonio Cisneros-Hernández , Joel Omar González-Cantero , Leivy Patricia González-Ramírez , Paulina Erika Herdoiza-Arroyo , Norma Alicia Ruvalcaba-Romero , Fabiola Macías-Espinoza , Said Jiménez","doi":"10.1016/j.conctc.2024.101397","DOIUrl":"10.1016/j.conctc.2024.101397","url":null,"abstract":"<div><h3>Background</h3><div>Some of the key challenges during the breast cancer diagnosis process include a lack of information and negative psychological consequences, such as distress and anxiety about the process. Implementing a psychoeducational program during the diagnosis process may enhance the well-being of women. “<em>Salud Mamaria</em>” is an Internet-Based Psychoeducational Program (IBPP) that comprises three interventions: A (“Improving Your Health Habits and Self-Care”), B (“Waiting for the Result of Your Biopsy”), and C (“Supporting You After Your Breast Cancer Diagnosis”).</div></div><div><h3>Objective</h3><div>1) To evaluate changes in the study variables following each of the three interventions (A, B, and C), and 2) To assess the differences in study variables between the IBPP and an active control group.</div></div><div><h3>Methods</h3><div>This is a superiority trial employing an experimental design with two independent groups: an experimental group and an active control group. All participants will be randomized to one of the two conditions. Anxiety symptoms, negative screening of consequences, sense of coherence, satisfaction with the intervention, and system usability will be measured. Patients will be assigned to an intervention based on their clinical situation: without cancer suspicion (A), with cancer suspicion (B), or diagnosed with cancer (C). Questionnaires will be administered via the online platform before and after each intervention.</div></div><div><h3>Conclusions</h3><div>A psychoeducational program implemented during the breast cancer screening and diagnosis process may promote the health and well-being of women. It may also encourage adherence to medical screening recommendations, mitigating the lack of information and reducing associated distress.</div></div><div><h3>Trial registration</h3><div>ClinicalTrials.gov <span><span>NCT05830461</span><svg><path></path></svg></span>.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"43 ","pages":"Article 101397"},"PeriodicalIF":1.4,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11722602/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142972503","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-02-01DOI: 10.1016/j.conctc.2024.101413
Jennifer Bannon , Justin D. Smith , Mark J. Van Ryzin , Megan McHugh , Jennifer Heinrich , Theresa L. Walunas , Abel N. Kho
Background
Unhealthy alcohol use is a leading cause of preventable mortality and a risk factor for an array of social and health problems. The Intervention in Small primary care Practices to Implement Reduction in unhealthy alcohol use (INSPIRE) study is part of a nationwide campaign to improve the identification and treatment of patients engaging in unhealthy alcohol use.
Methods
We conducted a single arm, pragmatic study consisting of seventeen primary care practices in the Chicago metropolitan area, Wisconsin, and California across two waves with a 6-month latent period, a 12-month intervention period, followed by a 6-month sustainability period. Enrolled practices were independent, Federally Qualified Health Centers, network-based, and academic health centers. INSPIRE utilized the RE-AIM (Reach, Effectiveness, Adoption, Implementation, Maintenance) framework to examine implementation feasibility, fidelity, and performance of clinicians on practice adoption of screening, brief intervention, referral to treatment (SBIRT) and medication for unhealthy alcohol use (MAUD) activities in primary care clinics.
Results
Seventeen eligible primary care practices were enrolled over the course of 21 months beginning in March of 2020 through December of 2021. There was a pause in recruitment from March of 2020 through July of 2020 due to the Covid-19 pandemic. The majority of enrolled practices were small (<6 clinicians) and were part of a network. 57 % of clinicians completed the educational modules in part or in full.
This paper will outline the INSPIRE protocol and design. Additionally, we will present practice demographic data, recruitment data and results related to on-line learning module completion.
Conclusion
The INSPIRE study will evaluate the ability of primary care clinicians in small practices to participate in practice education programs and implement standard screening and treatment protocols, adapted for documentation in the electronic health record (EHR). The study will also identify the factors that facilitated or hindered improvement and sustainability using quantitative and qualitative analysis methods.
{"title":"Design of INSPIRE: Evaluation of the effectiveness of practice facilitation on implementation of screening, brief interventions, referral to treatment and medication for unhealthy alcohol use identification and treatment in primary care","authors":"Jennifer Bannon , Justin D. Smith , Mark J. Van Ryzin , Megan McHugh , Jennifer Heinrich , Theresa L. Walunas , Abel N. Kho","doi":"10.1016/j.conctc.2024.101413","DOIUrl":"10.1016/j.conctc.2024.101413","url":null,"abstract":"<div><h3>Background</h3><div>Unhealthy alcohol use is a leading cause of preventable mortality and a risk factor for an array of social and health problems. The Intervention in Small primary care Practices to Implement Reduction in unhealthy alcohol use (INSPIRE) study is part of a nationwide campaign to improve the identification and treatment of patients engaging in unhealthy alcohol use.</div></div><div><h3>Methods</h3><div>We conducted a single arm, pragmatic study consisting of seventeen primary care practices in the Chicago metropolitan area, Wisconsin, and California across two waves with a 6-month latent period, a 12-month intervention period, followed by a 6-month sustainability period. Enrolled practices were independent, Federally Qualified Health Centers, network-based, and academic health centers. INSPIRE utilized the RE-AIM (Reach, Effectiveness, Adoption, Implementation, Maintenance) framework to examine implementation feasibility, fidelity, and performance of clinicians on practice adoption of screening, brief intervention, referral to treatment (SBIRT) and medication for unhealthy alcohol use (MAUD) activities in primary care clinics.</div></div><div><h3>Results</h3><div>Seventeen eligible primary care practices were enrolled over the course of 21 months beginning in March of 2020 through December of 2021. There was a pause in recruitment from March of 2020 through July of 2020 due to the Covid-19 pandemic. The majority of enrolled practices were small (<6 clinicians) and were part of a network. 57 % of clinicians completed the educational modules in part or in full.</div><div>This paper will outline the INSPIRE protocol and design. Additionally, we will present practice demographic data, recruitment data and results related to on-line learning module completion.</div></div><div><h3>Conclusion</h3><div>The INSPIRE study will evaluate the ability of primary care clinicians in small practices to participate in practice education programs and implement standard screening and treatment protocols, adapted for documentation in the electronic health record (EHR). The study will also identify the factors that facilitated or hindered improvement and sustainability using quantitative and qualitative analysis methods.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"43 ","pages":"Article 101413"},"PeriodicalIF":1.4,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11718291/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142972504","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-02-01DOI: 10.1016/j.conctc.2024.101419
Kirsten Austad , Cecilia Thai , Alegna Zavatti , Nhi Nguyen , Diana Bautista-Hurtado , Patrick Kenney , Noelia Lugo , Joo H. Lee , Howard Lanney , Ziming Xuan , Erika G. Cordova-Ramos , Mari-Lynn Drainoni , Brian Jack
Background
Written discharge instructions after hospitalization promote patient understanding and positive clinical outcomes. Despite the rising prevalence of patients with non-English language preference (NELP) in the U.S., most hospitals do not routinely provide discharge instructions in their preferred language, thereby placing them at higher risk for medical errors and hospital readmission. Innovative solutions to close this implementation gap at hospital discharge for patients with NELP are needed. The Tools to Improve Discharge Equity (TIDE) intervention leverages communication practices proven effective in addressing communication barriers to create language concordant discharge tools from hospital discharge paperwork.
Methods
We present the protocol for a type I hybrid implementation-effectiveness pilot randomized trial. The TIDE intervention includes a translated medication calendar, pictographs, and an audio recording of the discharge instructions in the patient's preferred language. We will recruit an estimated 50 patient participants from the hospital's top four non-English language groups—Spanish, Haitian Creole, Cape Verdean Creole, and Vietnamese—as well as the nurse and in-person interpreter caring for them. Outcomes include patient recall of primary diagnosis and overall understanding of discharge instructions using a newly developed 24-point score, patient experience, implementation measures (acceptability, feasibility, and appropriateness), and clinical effectiveness (including hospital reutilization). A mixed methods evaluation will identify determinants of intervention uptake to guide selection of multi-level implementation strategies to test in a future hybrid type III trial.
Discussion
The TIDE intervention is the first hospital discharge intervention designed for patients with NELP. Result will inform future efforts to improve the safety and equity of the hospital discharge process.
{"title":"Tools to improve discharge equity: Protocol for the pilot TIDE trial","authors":"Kirsten Austad , Cecilia Thai , Alegna Zavatti , Nhi Nguyen , Diana Bautista-Hurtado , Patrick Kenney , Noelia Lugo , Joo H. Lee , Howard Lanney , Ziming Xuan , Erika G. Cordova-Ramos , Mari-Lynn Drainoni , Brian Jack","doi":"10.1016/j.conctc.2024.101419","DOIUrl":"10.1016/j.conctc.2024.101419","url":null,"abstract":"<div><h3>Background</h3><div>Written discharge instructions after hospitalization promote patient understanding and positive clinical outcomes. Despite the rising prevalence of patients with non-English language preference (NELP) in the U.S., most hospitals do not routinely provide discharge instructions in their preferred language, thereby placing them at higher risk for medical errors and hospital readmission. Innovative solutions to close this implementation gap at hospital discharge for patients with NELP are needed. The Tools to Improve Discharge Equity (TIDE) intervention leverages communication practices proven effective in addressing communication barriers to create language concordant discharge tools from hospital discharge paperwork.</div></div><div><h3>Methods</h3><div>We present the protocol for a type I hybrid implementation-effectiveness pilot randomized trial. The TIDE intervention includes a translated medication calendar, pictographs, and an audio recording of the discharge instructions in the patient's preferred language. We will recruit an estimated 50 patient participants from the hospital's top four non-English language groups—Spanish, Haitian Creole, Cape Verdean Creole, and Vietnamese—as well as the nurse and in-person interpreter caring for them. Outcomes include patient recall of primary diagnosis and overall understanding of discharge instructions using a newly developed 24-point score, patient experience, implementation measures (acceptability, feasibility, and appropriateness), and clinical effectiveness (including hospital reutilization). A mixed methods evaluation will identify determinants of intervention uptake to guide selection of multi-level implementation strategies to test in a future hybrid type III trial.</div></div><div><h3>Discussion</h3><div>The TIDE intervention is the first hospital discharge intervention designed for patients with NELP. Result will inform future efforts to improve the safety and equity of the hospital discharge process.</div></div><div><h3>Trial registration</h3><div>clinicaltrials.gov <span><span>NCT05988229</span><svg><path></path></svg></span> (August 14, 2023) <span><span>https://classic.clinicaltrials.gov/ct2/show/NCT05988229</span><svg><path></path></svg></span>.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"43 ","pages":"Article 101419"},"PeriodicalIF":1.4,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11731754/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142984105","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-02-01DOI: 10.1016/j.conctc.2024.101421
Yu Chen Lin , Jose M. Pimiento , Jeanine Milano , Diane Riccardi , Nakesha Mckinnie , Emma Hume , Olivia Sprow , Sophia Diaz-Carraway , Mara Budnetz , Ryan Hagen , Mohammed Al-Jumayli , Allan Lima Pereira , Andrew J. Sinnamon , Ashwin Somasundaram , Jennifer B. Permuth , Amir Alishahi Tabriz , Kea Turner
Introduction
Individuals with esophageal and gastroesophageal junction (GEJ) cancers are at especially high risk of malnutrition. However, most patients with malnutrition do not receive adequate nutritional support. We conducted a single-arm trial to test the implementation of Support Through Remote Observation and Nutrition Guidance (STRONG), a multilevel digital intervention to improve nutritional outcomes for patients with locally advanced esophageal and gastroesophageal junction cancer.
Methods
Participants received five nutritional counseling sessions with a dietitian, logged daily food intake through the Fitbit app, and completed five study assessments related to patient malnutrition, nutrition-related symptoms, and quality-of-life outcomes. We assessed the feasibility, acceptability, and usability of STRONG against a priori benchmarks.
Results
Participants (N = 17) had a median age of 68 years, and 71 % were male. Feasibility benchmarks were met for participants completing the baseline assessment (94 %), completing four out of five assessments (82 %), and participant retention (85 %). Among participants who only received an oral diet during the study period, adherence to dietetic appointments (89 %) and food intake tracking (78 %) were high. Participant recruitment rate (47 %) was slightly below the benchmark (50 %). All participants found the intervention to be acceptable. Usability of the intervention was high, with 69 % and 92 % of participants reporting high satisfaction with tracking food intake through the Fitbit and the dietitian-led nutrition counseling sessions, respectively.
Conclusion
Our study demonstrated that STRONG could be implemented with high feasibility, acceptability, and usability for esophageal and GEJ cancer patients. Findings from this study can guide a future efficacy study to assess the impact of STRONG on patient outcomes.
Clinical trial registration
The Support Through Remote Observation and Nutrition Guidance Program for Gastroesophageal Cancer Patients (STRONG-GEC) study was registered on clinicaltrials.gov (NCT05438940) in June 2022 prior to participant enrollment.
{"title":"Feasibility trial of STRONG: A digital intervention to improve nutritional management for individuals with esophageal and gastroesophageal junction cancer","authors":"Yu Chen Lin , Jose M. Pimiento , Jeanine Milano , Diane Riccardi , Nakesha Mckinnie , Emma Hume , Olivia Sprow , Sophia Diaz-Carraway , Mara Budnetz , Ryan Hagen , Mohammed Al-Jumayli , Allan Lima Pereira , Andrew J. Sinnamon , Ashwin Somasundaram , Jennifer B. Permuth , Amir Alishahi Tabriz , Kea Turner","doi":"10.1016/j.conctc.2024.101421","DOIUrl":"10.1016/j.conctc.2024.101421","url":null,"abstract":"<div><h3>Introduction</h3><div>Individuals with esophageal and gastroesophageal junction (GEJ) cancers are at especially high risk of malnutrition. However, most patients with malnutrition do not receive adequate nutritional support. We conducted a single-arm trial to test the implementation of Support Through Remote Observation and Nutrition Guidance (STRONG), a multilevel digital intervention to improve nutritional outcomes for patients with locally advanced esophageal and gastroesophageal junction cancer.</div></div><div><h3>Methods</h3><div>Participants received five nutritional counseling sessions with a dietitian, logged daily food intake through the Fitbit app, and completed five study assessments related to patient malnutrition, nutrition-related symptoms, and quality-of-life outcomes. We assessed the feasibility, acceptability, and usability of STRONG against a priori benchmarks.</div></div><div><h3>Results</h3><div>Participants (N = 17) had a median age of 68 years, and 71 % were male. Feasibility benchmarks were met for participants completing the baseline assessment (94 %), completing four out of five assessments (82 %), and participant retention (85 %). Among participants who only received an oral diet during the study period, adherence to dietetic appointments (89 %) and food intake tracking (78 %) were high. Participant recruitment rate (47 %) was slightly below the benchmark (50 %). All participants found the intervention to be acceptable. Usability of the intervention was high, with 69 % and 92 % of participants reporting high satisfaction with tracking food intake through the Fitbit and the dietitian-led nutrition counseling sessions, respectively.</div></div><div><h3>Conclusion</h3><div>Our study demonstrated that STRONG could be implemented with high feasibility, acceptability, and usability for esophageal and GEJ cancer patients. Findings from this study can guide a future efficacy study to assess the impact of STRONG on patient outcomes.</div></div><div><h3>Clinical trial registration</h3><div>The Support Through Remote Observation and Nutrition Guidance Program for Gastroesophageal Cancer Patients (STRONG-GEC) study was registered on clinicaltrials.gov (NCT05438940) in June 2022 prior to participant enrollment.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"43 ","pages":"Article 101421"},"PeriodicalIF":1.4,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11732474/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142985094","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-02-01DOI: 10.1016/j.conctc.2024.101417
Jakub Szrama, Agata Gradys, Zuzanna Nowak, Ashish Lohani, Krzysztof Zwoliński, Tomasz Bartkowiak, Amadeusz Woźniak, Tomasz Koszel, Krzysztof Kusza
Background
Patients undergoing major abdominal surgery are at increased risk of developing perioperative hypotension, which is associated with increased mortality and morbidity. Despite using advanced technologies such as evaluating arterial pressure derived cardiac output, anaesthetic management to maintain hemodynamic stability is still reactive when the clinical decision is made after hypotension has developed. Previous perioperative goal-directed studies have not proven the benefits of this approach with high certainty. A new, approved technology called the Hypotension Prediction Index (HPI) aims to prevent hypotension occurrence by allowing the precise hemodynamic monitoring of patients under general anaesthesia, significantly reducing intraoperative hypotension events. This prospective randomised clinical trial aims to compare the rate of perioperative hypotension in patients undergoing major abdominal surgery according to their type of hemodynamic monitoring.
Methods
and Analysis: Patients meeting the inclusion criteria will be randomly assigned to receive hemodynamic assessment with arterial pressure cardiac output (APCO) monitoring (group A) or hemodynamic monitoring with the HPI software (group B). The primary outcome is a time-weighted average (TWA) mean arterial pressure (MAP) of <65 mmHg: TWA MAP = (depth of hypotension [in mmHg] below a MAP of 65 mmHg × time [in minutes] spent below a MAP of 65 mmHg)/total duration of the operation (in minutes). Its secondary outcomes include perioperative hemodynamic management and the rate of postoperative complications.
Ethics and dissemination
This trial was approved by the Ethics Committee of the Poznan University of Medical Sciences (KB–559/220; date: 01/07/2022). Its results will be submitted for publication in a peer-reviewed journal.
Trial registration number
NCT06247384.
{"title":"The hypotension prediction index in major abdominal surgery – A prospective randomised clinical trial protocol","authors":"Jakub Szrama, Agata Gradys, Zuzanna Nowak, Ashish Lohani, Krzysztof Zwoliński, Tomasz Bartkowiak, Amadeusz Woźniak, Tomasz Koszel, Krzysztof Kusza","doi":"10.1016/j.conctc.2024.101417","DOIUrl":"10.1016/j.conctc.2024.101417","url":null,"abstract":"<div><h3>Background</h3><div>Patients undergoing major abdominal surgery are at increased risk of developing perioperative hypotension, which is associated with increased mortality and morbidity. Despite using advanced technologies such as evaluating arterial pressure derived cardiac output, anaesthetic management to maintain hemodynamic stability is still reactive when the clinical decision is made after hypotension has developed. Previous perioperative goal-directed studies have not proven the benefits of this approach with high certainty. A new, approved technology called the Hypotension Prediction Index (HPI) aims to prevent hypotension occurrence by allowing the precise hemodynamic monitoring of patients under general anaesthesia, significantly reducing intraoperative hypotension events. This prospective randomised clinical trial aims to compare the rate of perioperative hypotension in patients undergoing major abdominal surgery according to their type of hemodynamic monitoring.</div></div><div><h3>Methods</h3><div><em>and Analysis</em>: Patients meeting the inclusion criteria will be randomly assigned to receive hemodynamic assessment with arterial pressure cardiac output (APCO) monitoring (group A) or hemodynamic monitoring with the HPI software (group B). The primary outcome is a time-weighted average (TWA) mean arterial pressure (MAP) of <65 mmHg: TWA MAP = (depth of hypotension [in mmHg] below a MAP of 65 mmHg × time [in minutes] spent below a MAP of 65 mmHg)/total duration of the operation (in minutes). Its secondary outcomes include perioperative hemodynamic management and the rate of postoperative complications.</div></div><div><h3>Ethics and dissemination</h3><div>This trial was approved by the Ethics Committee of the Poznan University of Medical Sciences (KB–559/220; date: 01/07/2022). Its results will be submitted for publication in a peer-reviewed journal.</div></div><div><h3>Trial registration number</h3><div>NCT06247384.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"43 ","pages":"Article 101417"},"PeriodicalIF":1.4,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11784284/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143081679","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-02-01DOI: 10.1016/j.conctc.2024.101396
Chelsea Ye , Tatiana Shablinski , Susan E. Shoaf , Chris Chung , Michelle Bullock
Background
The COVID-19 pandemic accelerated a shift to decentralized clinical trials. We present the potential feasibility of this approach from a phase 1 pharmacokinetic (PK) trial.
Methods
Healthy adults (18–55 years) with a body mass index of 19.0–32.0 kg/m2 were enrolled. The trial comprised a screening period, 2 clinic visits (visits 1, 2), 2 at-home visits (visits 3 and 4), and follow-up clinic visit (visit 5). Participants received a single 100-mg oral dose of centanafadine sustained release at visits 1, 2, and 4. Pharmacokinetic samples, electrocardiograms (ECGs; 6-lead [participant] and 12-lead [staff]), and vital signs were collected by clinical personnel (visit 1), under staff supervision (visit 2), and remotely (visit 4), facilitated by the Verily clinical trial application. Successful sample collection at visit 4 was reported descriptively. A survey assessed the utility of training, devices, and the Verily app, and ability to complete trial procedures.
Results
Among 20 participants enrolled, 90 % were female, mean (SD) age was 35.9 (11.1) years. Verily platform/procedures facilitated successful remote vital sign collection in at least 75 %, ECGs in at least 80 %, and blood microsamples in 65 %–70 % of participants at visit 4. Most agreed that training was adequate, and they were able to complete trial procedures on their own. Participants favored self-collection over staff collection, having visits in their own location, and would consider participation in similar future research.
Conclusions
Results from this decentralized PK trial, with remote, in-home sample collection and monitoring, demonstrated the potential feasibility of this study design.
{"title":"Conducting clinical trials with self-collection of pharmacokinetic samples: Experience from an exploratory, phase 1, open-label trial of centanafadine SR in healthy individuals","authors":"Chelsea Ye , Tatiana Shablinski , Susan E. Shoaf , Chris Chung , Michelle Bullock","doi":"10.1016/j.conctc.2024.101396","DOIUrl":"10.1016/j.conctc.2024.101396","url":null,"abstract":"<div><h3>Background</h3><div>The COVID-19 pandemic accelerated a shift to decentralized clinical trials. We present the potential feasibility of this approach from a phase 1 pharmacokinetic (PK) trial.</div></div><div><h3>Methods</h3><div>Healthy adults (18–55 years) with a body mass index of 19.0–32.0 kg/m<sup>2</sup> were enrolled. The trial comprised a screening period, 2 clinic visits (visits 1, 2), 2 at-home visits (visits 3 and 4), and follow-up clinic visit (visit 5). Participants received a single 100-mg oral dose of centanafadine sustained release at visits 1, 2, and 4. Pharmacokinetic samples, electrocardiograms (ECGs; 6-lead [participant] and 12-lead [staff]), and vital signs were collected by clinical personnel (visit 1), under staff supervision (visit 2), and remotely (visit 4), facilitated by the Verily clinical trial application. Successful sample collection at visit 4 was reported descriptively. A survey assessed the utility of training, devices, and the Verily app, and ability to complete trial procedures.</div></div><div><h3>Results</h3><div>Among 20 participants enrolled, 90 % were female, mean (SD) age was 35.9 (11.1) years. Verily platform/procedures facilitated successful remote vital sign collection in at least 75 %, ECGs in at least 80 %, and blood microsamples in 65 %–70 % of participants at visit 4. Most agreed that training was adequate, and they were able to complete trial procedures on their own. Participants favored self-collection over staff collection, having visits in their own location, and would consider participation in similar future research.</div></div><div><h3>Conclusions</h3><div>Results from this decentralized PK trial, with remote, in-home sample collection and monitoring, demonstrated the potential feasibility of this study design.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"43 ","pages":"Article 101396"},"PeriodicalIF":1.4,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11731279/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142985091","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-02-01DOI: 10.1016/j.conctc.2024.101412
Tina L. Schuh , Kathleen R. Diviak , Sarai Coba-Rodriguez , Emily Pela , Raphael Kinney , Michael L. Berbaum , Amanda Klemas , Kruti Acharya , Molly Martin , Reshma Shah
Societal and structural inequities have resulted in longstanding health care disparities among Black, Latino/a/e, and low-income preschool children with developmental delays and disabilities (PCw/DD), depriving them of educational and therapeutic services that improve future academic, economic, and health outcomes. To address this issue, we developed Preschool and Me (PreM), a community-clinical linkage (CCL) implemented within healthcare settings serving historically marginalized communities. This novel CCL, an educational-medical linkage model, aims to increase access to school-based services for PCw/DD. Combining key components of CCLs with a personalized medical-education care plan and remote navigator support, PreM targets multiple levels of influence impacting access to school-based therapeutic and educational services. We will utilize a hybrid effectiveness-implementation approach in two models of real-world service delivery conditions. Participants (n = 320) will be randomized to either 6 months of PreM or a waitlist control arm beginning the intervention after a 6-month delay. Our specific aims are to test the effectiveness of PreM on access to school-based services as well as health service outcomes; examine mediators of intervention effects using a mixed-methods approach; and explore social determinants of health as potential moderators. We will simultaneously conduct an implementation evaluation. The results of this study have the potential to support effective implementation of CCL models within pediatric clinical settings serving historically marginalized communities which can be utilized to improve health outcomes for families and their children with a range of health conditions.
{"title":"Preschool and Me: Educational-clinical linkage to improve health equity for children with developmental delays and disabilities from historically marginalized communities","authors":"Tina L. Schuh , Kathleen R. Diviak , Sarai Coba-Rodriguez , Emily Pela , Raphael Kinney , Michael L. Berbaum , Amanda Klemas , Kruti Acharya , Molly Martin , Reshma Shah","doi":"10.1016/j.conctc.2024.101412","DOIUrl":"10.1016/j.conctc.2024.101412","url":null,"abstract":"<div><div>Societal and structural inequities have resulted in longstanding health care disparities among Black, Latino/a/e, and low-income preschool children with developmental delays and disabilities (PCw/DD), depriving them of educational and therapeutic services that improve future academic, economic, and health outcomes. To address this issue, we developed Preschool and Me (PreM), a community-clinical linkage (CCL) implemented within healthcare settings serving historically marginalized communities. This novel CCL, an educational-medical linkage model, aims to increase access to school-based services for PCw/DD. Combining key components of CCLs with a personalized medical-education care plan and remote navigator support, PreM targets multiple levels of influence impacting access to school-based therapeutic and educational services. We will utilize a hybrid effectiveness-implementation approach in two models of real-world service delivery conditions. Participants (n = 320) will be randomized to either 6 months of PreM or a waitlist control arm beginning the intervention after a 6-month delay. Our specific aims are to test the effectiveness of PreM on access to school-based services as well as health service outcomes; examine mediators of intervention effects using a mixed-methods approach; and explore social determinants of health as potential moderators. We will simultaneously conduct an implementation evaluation. The results of this study have the potential to support effective implementation of <span>CCL</span> models within pediatric clinical settings serving historically marginalized communities which can be utilized to improve health outcomes for families and their children with a range of health conditions.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"43 ","pages":"Article 101412"},"PeriodicalIF":1.4,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11699437/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142932930","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-02-01DOI: 10.1016/j.conctc.2024.101408
Christine Lykke Thoustrup , Camilla Uhre , Valdemar Uhre , Melanie Ritter , Signe Vangkilde , Janus Engstrøm , Jane Lindschou , Christian Gluud , Anne Katrine Pagsberg , Markus Harboe Olsen
Background
Research on improving psychotherapy for youths with obsessive-compulsive disorder (OCD), including cognitive behavioral therapy (CBT), should explore what works for whom and how by examining baseline moderators and potential mechanisms of change. Emotion dysregulation is proposed as an intermediate therapy factor in a transdiagnostic framework. This study investigates emotion dysregulation as an outcome, mechanism, and moderator of psychotherapy in youths aged 8–17 years with OCD.
Methods
Data are from a randomized clinical trial and a parallel prospective study of healthy controls. Participants with OCD (n = 130; 121 in this study) were randomized to 14 sessions of either family-based CBT with exposure and response prevention versus family-based psychoeducation and relaxation training. We will; 1) assess if emotion dysregulation, measured by the Difficulties in Emotion Regulation Scale (DERS), decreases from baseline to end-of-treatment; 2) compare the proportion of participants with normative emotion regulation to a 90% reference interval from healthy controls (n = 90); 3) use linear regression to examine if baseline emotion dysregulation moderates treatment effects measured by the Children's Yale-Brown Obsessive-Compulsive Scale; 4) investigate if changes in emotion dysregulation mediate treatment effects; and 5) investigate the stability of emotion regulation over time in the healthy controls. Analyses 1–4 will be conducted for all OCD participants and separately for the two treatment groups. Two independent investigators will perform the analyses.
Conclusion
This protocol and statistical analysis plan are presented to enhance analytical transparency and limit bias.
{"title":"Emotion dysregulation in youths with obsessive-compulsive disorder and its implication for treatment - An exploratory study from the TECTO trial: A protocol and statistical analysis plan","authors":"Christine Lykke Thoustrup , Camilla Uhre , Valdemar Uhre , Melanie Ritter , Signe Vangkilde , Janus Engstrøm , Jane Lindschou , Christian Gluud , Anne Katrine Pagsberg , Markus Harboe Olsen","doi":"10.1016/j.conctc.2024.101408","DOIUrl":"10.1016/j.conctc.2024.101408","url":null,"abstract":"<div><h3>Background</h3><div>Research on improving psychotherapy for youths with obsessive-compulsive disorder (OCD), including cognitive behavioral therapy (CBT), should explore what works for whom and how by examining baseline moderators and potential mechanisms of change. Emotion dysregulation is proposed as an intermediate therapy factor in a transdiagnostic framework. This study investigates emotion dysregulation as an outcome, mechanism, and moderator of psychotherapy in youths aged 8–17 years with OCD.</div></div><div><h3>Methods</h3><div>Data are from a randomized clinical trial and a parallel prospective study of healthy controls. Participants with OCD (n = 130; 121 in this study) were randomized to 14 sessions of either family-based CBT with exposure and response prevention versus family-based psychoeducation and relaxation training. We will; 1) assess if emotion dysregulation, measured by the Difficulties in Emotion Regulation Scale (DERS), decreases from baseline to end-of-treatment; 2) compare the proportion of participants with normative emotion regulation to a 90% reference interval from healthy controls (n = 90); 3) use linear regression to examine if baseline emotion dysregulation moderates treatment effects measured by the Children's Yale-Brown Obsessive-Compulsive Scale; 4) investigate if changes in emotion dysregulation mediate treatment effects; and 5) investigate the stability of emotion regulation over time in the healthy controls. Analyses 1–4 will be conducted for all OCD participants and separately for the two treatment groups. Two independent investigators will perform the analyses.</div></div><div><h3>Conclusion</h3><div>This protocol and statistical analysis plan are presented to enhance analytical transparency and limit bias.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"43 ","pages":"Article 101408"},"PeriodicalIF":1.4,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11718327/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142972505","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-02-01DOI: 10.1016/j.conctc.2024.101424
Juan Antonio Carrillo-Norte , Guillermo Gervasini-Rodríguez , María Ángeles Santiago-Triviño , Virginio García-López , Rafael Guerrero-Bonmatty
Osteoarthritis (OA) is a major source of chronic pain and disability, representing a significant global health concern that affects 10–15 % of individuals aged over 60, with a higher prevalence among females than males. This investigation aimed to evaluate the impact of a dietary supplement containing collagen peptides (MW 1–3 kDa) on knee OA symptoms and inflammatory biomarkers such as C-reactive protein (CRP) and erythrocyte sedimentation rate (ESR). Adults aged 30–81 years (50 % female) with grade II or III OA and a minimum pain score of 40 on the 0 to 100 visual analogue scale (VAS) were enrolled. Participants were randomly assigned to receive either 10 g of the test product (verum group) or placebo and were assessed at baseline (T0, pre-treatment) and after a six-month follow-up period (T6). Baseline characteristics were comparable between groups. At T6, the verum group exhibited significant reductions in VAS pain scores, Lequesne algofunctional index (LAI) scores, CRP levels (mg/L), and ESR (mm/h) compared to placebo (p < 0.001). No adverse effects were reported during the study, and the supplement demonstrated good tolerability and yielded satisfactory safety and acceptability. These findings suggest that the dietary supplement may serve as a complement to drug therapy for knee OA by alleviating osteoarticular pain, improving locomotor function and potentially reducing reliance on analgesic and anti-inflammatory medications. This study provides valuable insights into the efficacy and safety of collagen peptides in managing knee OA symptoms.
{"title":"Oral administration of hydrolyzed collagen alleviates pain and enhances functionality in knee osteoarthritis: Results from a randomized, double-blind, placebo-controlled study","authors":"Juan Antonio Carrillo-Norte , Guillermo Gervasini-Rodríguez , María Ángeles Santiago-Triviño , Virginio García-López , Rafael Guerrero-Bonmatty","doi":"10.1016/j.conctc.2024.101424","DOIUrl":"10.1016/j.conctc.2024.101424","url":null,"abstract":"<div><div>Osteoarthritis (OA) is a major source of chronic pain and disability, representing a significant global health concern that affects 10–15 % of individuals aged over 60, with a higher prevalence among females than males. This investigation aimed to evaluate the impact of a dietary supplement containing collagen peptides (MW 1–3 kDa) on knee OA symptoms and inflammatory biomarkers such as C-reactive protein (CRP) and erythrocyte sedimentation rate (ESR). Adults aged 30–81 years (50 % female) with grade II or III OA and a minimum pain score of 40 on the 0 to 100 visual analogue scale (VAS) were enrolled. Participants were randomly assigned to receive either 10 g of the test product (verum group) or placebo and were assessed at baseline (T0, pre-treatment) and after a six-month follow-up period (T6). Baseline characteristics were comparable between groups. At T6, the verum group exhibited significant reductions in VAS pain scores, Lequesne algofunctional index (LAI) scores, CRP levels (mg/L), and ESR (mm/h) compared to placebo (p < 0.001). No adverse effects were reported during the study, and the supplement demonstrated good tolerability and yielded satisfactory safety and acceptability. These findings suggest that the dietary supplement may serve as a complement to drug therapy for knee OA by alleviating osteoarticular pain, improving locomotor function and potentially reducing reliance on analgesic and anti-inflammatory medications. This study provides valuable insights into the efficacy and safety of collagen peptides in managing knee OA symptoms.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"43 ","pages":"Article 101424"},"PeriodicalIF":1.4,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11745964/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143013228","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-02-01DOI: 10.1016/j.conctc.2024.101411
Emma Tenison , Katherine Lloyd , Yoav Ben-Shlomo , Emily J. Henderson
Background/aims
In the absence of disease-modifying therapies for Parkinson's disease, much research focuses on improving quality of life, health and wellbeing. It is important to evaluate potential treatments and innovative care models in a robust and standardised way. Disease-specific outcomes have limitations in older people, those with cognitive impairment, multimorbidity, disability or short life expectancy. We aimed to select, and adapt as needed, a primary outcome to evaluate a multicomponent intervention for people with parkinsonism.
Methods
The multicomponent Proactive and Integrated Management and Empowerment (PRIME) model of care is being evaluated in the UK within a randomized controlled trial (RCT). We needed a meaningful outcome measure which could capture effects across multiple symptoms and domains; be suitable across the spectrum of disease stage/phenotype, including for participants with multimorbidity and/or cognitive impairment.
Results
We have chosen the Bangor Goal-setting Interview and adapted it for use within the PRIME-UK RCT. This includes 4 steps: participants 1) identify an area to work on; 2) describe a specific goal; 3) rate current attainment, readiness to change and goal importance; and 4) attainment is followed up 3-monthly. Change in ratings across three to five individualised goals on a standardised scale can be compared between trial arms.
Conclusion
We demonstrate how a goal-orientated outcome can be operationalized within a complex intervention trial for parkinsonism. Parkinsonism is an exemplar multisystem, heterogeneous condition, predominantly affecting older people. There is scope to use goal-orientated outcome measures more widely in trials involving patients living with frailty, multimorbidity and/or clinical complexity.
{"title":"Operationalizing goal setting as an outcome measure in trials involving patients with frailty, multimorbidity or complexity","authors":"Emma Tenison , Katherine Lloyd , Yoav Ben-Shlomo , Emily J. Henderson","doi":"10.1016/j.conctc.2024.101411","DOIUrl":"10.1016/j.conctc.2024.101411","url":null,"abstract":"<div><h3>Background/aims</h3><div>In the absence of disease-modifying therapies for Parkinson's disease, much research focuses on improving quality of life, health and wellbeing. It is important to evaluate potential treatments and innovative care models in a robust and standardised way. Disease-specific outcomes have limitations in older people, those with cognitive impairment, multimorbidity, disability or short life expectancy. We aimed to select, and adapt as needed, a primary outcome to evaluate a multicomponent intervention for people with parkinsonism.</div></div><div><h3>Methods</h3><div>The multicomponent Proactive and Integrated Management and Empowerment (PRIME) model of care is being evaluated in the UK within a randomized controlled trial (RCT). We needed a meaningful outcome measure which could capture effects across multiple symptoms and domains; be suitable across the spectrum of disease stage/phenotype, including for participants with multimorbidity and/or cognitive impairment.</div></div><div><h3>Results</h3><div>We have chosen the Bangor Goal-setting Interview and adapted it for use within the PRIME-UK RCT. This includes 4 steps: participants 1) identify an area to work on; 2) describe a specific goal; 3) rate current attainment, readiness to change and goal importance; and 4) attainment is followed up 3-monthly. Change in ratings across three to five individualised goals on a standardised scale can be compared between trial arms.</div></div><div><h3>Conclusion</h3><div>We demonstrate how a goal-orientated outcome can be operationalized within a complex intervention trial for parkinsonism. Parkinsonism is an exemplar multisystem, heterogeneous condition, predominantly affecting older people. There is scope to use goal-orientated outcome measures more widely in trials involving patients living with frailty, multimorbidity and/or clinical complexity.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"43 ","pages":"Article 101411"},"PeriodicalIF":1.4,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11699366/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142932928","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
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