Contemporary clinical trials
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Contemp Clin Trials · Mar 2020
Randomized Controlled TrialThe chronic pain skills study: Protocol for a randomized controlled trial comparing hypnosis, mindfulness meditation and pain education in Veterans.
To describe the protocol of a randomized controlled trial to evaluate the effectiveness and mechanisms of three behavioral interventions. ⋯ The study treatments will be administered at a large Veterans Affairs Medical Center in the northwest United States. The treatments will be integrated within clinical infrastructure and delivered by licensed and credentialed health care professionals.
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Contemp Clin Trials · Feb 2020
Randomized Controlled Trial Multicenter StudyMemory advancement by intranasal insulin in type 2 diabetes (MemAID) randomized controlled clinical trial: Design, methods and rationale.
Type 2 diabetes mellitus (T2DM) accelerates brain aging and increases the risk for dementia. Insulin is a key neurotrophic factor in the brain, where it modulates energy metabolism, neurovascular coupling, and regeneration. Impaired insulin-mediated brain signaling and central insulin resistance may contribute to cognitive and functional decline in T2DM. Intranasal insulin (INI) has emerged as a potential therapy for treating T2DM-related cognitive impairment. ⋯ This study addresses an important knowledge gap about the long-term effects of intranasal insulin on memory and cognition in older people with T2DM and non-diabetic controls, and may provide a novel therapeutic target for prevention and treatment of cognitive and functional decline and dementia. Trial Registration NCT02415556.
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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 · Feb 2019
Randomized Controlled TrialRationale and design of Smart Walk: A randomized controlled pilot trial of a smartphone-delivered physical activity and cardiometabolic risk reduction intervention for African American women.
African American (AA) women perform low levels of physical activity (PA) and are disproportionally burdened by cardiometabolic disease conditions when compared to White women and the U.S. population as a whole. These disparities emphasize the need for innovative and effective interventions to increase PA and reduce cardiometabolic disease risk among AA women. Recent evidence suggests that mobile health (mHealth) interventions have the potential to increase PA and reduce cardiometabolic disease risk factors. Few studies have examined the efficacy of mHealth PA interventions among racial/ethnic minorities, including AA women. This represents a missed opportunity given the reported success of technology-delivered PA interventions in predominately White populations and the high use of technology among AA women. ⋯ Smart Walk represents a culturally relevant, theory-based approach to promote PA and reduce cardiometabolic disease risk in AA women.