Contemporary clinical trials
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Contemp Clin Trials · Jul 2019
Strong Hearts for New York: A multilevel community-based randomized cardiovascular disease risk reduction intervention for rural women.
Rural midlife and older women have high rates of cardiovascular disease (CVD) risk factors and lower access to healthy living resources. The Strong Hearts, Healthy Communities (SHHC) intervention, tailored to the needs of rural women, demonstrated effectiveness on many outcomes. The purpose of the Strong Hearts for New York (SHNY) study is to evaluate the efficacy of an enhanced version of the curriculum (SHHC-2.0). ⋯ The aims of this study are to evaluate the efficacy of the enhanced SHHC-2.0 program for participants, changes among participants' social networks, and the difference in outcomes when participants are and are not provided with technological tools (Fitbit and body composition scale).
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Contemp Clin Trials · Jul 2019
Study protocol for targeted interventions to prevent chronic low back pain in high-risk patients: A multi-site pragmatic cluster randomized controlled trial (TARGET Trial).
Low back pain (LBP) is one of the most prevalent and potentially disabling conditions for which people seek health care. Patients, providers, and payers agree that greater effort is needed to prevent acute LBP from transitioning to chronic LBP. ⋯ The TARGET pragmatic trial aims to establish the effectiveness of the stratified approach to acute LBP intervention targeting high-risk patients with GBC and PIPT.
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Contemp Clin Trials · May 2019
Randomized Controlled Trial Multicenter StudyDesign and recruitment of the randomized order safety trial evaluating resident-physician schedules (ROSTERS) study.
While the Accreditation Council for Graduate Medical Education limited first year resident-physicians to 16 consecutive work hours from 2011 to 2017, resident-physicians in their second year or higher were permitted to work up to 28 h consecutively. This paper describes the Randomized Order Safety Trial Evaluating Resident-physician Schedules (ROSTERS) study, a clustered-randomized crossover clinical trial designed to evaluate the effectiveness of eliminating traditional shifts of 24 h or longer for second year or higher resident-physicians in pediatric intensive care units (PICUs). ⋯ Results from data collected in the ROSTERS study will be evaluated for the impact of resident-physician schedule roster on patient safety outcomes in PICUs, and will allow for examination of a number of secondary outcome measures. ClinicalTrials.gov Identifier: NCT02134847.
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Contemp Clin Trials · Apr 2019
Randomized Controlled Trial Multicenter StudyDoes outpatient palliative care improve patient-centered outcomes in Parkinson's disease: Rationale, design, and implementation of a pragmatic comparative effectiveness trial.
Patients with Parkinson's disease and related disorders (PDRD) and their families have considerable unmet needs including non-motor symptom management, caregiver support, spiritual wellbeing, advance care planning, and end-of-life care. There is increasing interest in applying palliative care (PC) models to better meet these needs. While PC has been shown to improve care and quality of life (QOL) for people with cancer and heart failure, few studies have evaluated the role of PC for people with PDRD. ⋯ As a novel application of PC, challenges involved in the design of this study include choosing appropriate inclusion criteria, standardizing the intervention, defining usual care, and choosing outcome measures suitable to our research questions. Challenges involved in implementation include participant recruitment, retention, and management of participant burden. We anticipate the results of this trial will have relevance for both clinical care and future clinical research trial design in evaluating models of PC for people with PDRD and other serious illnesses.
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Contemp Clin Trials · Mar 2019
Synthesis of researcher reported strategies to recruit adults of ethnic minorities to clinical trials in the United Kingdom: A systematic review.
People from ethnic minorities are reported to have higher rates of physical illness (diabetes and ischemic heart disease) and mental disorders. Disparities relate not just to diagnosis, but also to care pathways and treatment outcomes. Despite this, they are underrepresented in clinical research. This reduces the generalisability of research findings across multi ethnic populations and hinders the development of accessible services. Researchers often face difficulties in recruiting ethnic minority participants to clinical research due to low levels of cultural competence and limited resources. There are few published trials focusing on ethnic minorities in the UK and we need to understand what recruitment strategies have already been implemented and recommended when recruiting ethnic participants. This will help researchers in applying these lessons to future clinical trials. ⋯ The review highlighted that researchers employed limited strategies to enhance the recruitment level. The full extent of the use of strategies was not described well in the publications. There is a need for wider training and support for the trialist to enhance and build up recruitment skills to facilitate the recruitment of ethnic minorities to clinical trials.