Treatment Trials

7 Clinical Trials for Various Conditions

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COMPLETED
Interventions to Promote Well-being of Nightshift Nursing Team Members
Description

Background: Nightshift health care employees can experience greater likelihood of health threats such as weight gain, hypertension, and sleep disturbances. Evidence indicates a willingness of nightshift health care professionals to engage in wellness activities initiated at the work setting and during the assigned nightshift. In this single site study at a freestanding pediatric tertiary care hospital, inpatient units will be randomized to one of two nightshift interventions during an 8-week study period (mindfulness plus sleep hygiene or physical activity plus sleep hygiene). Immediately following the first study period, the randomized units will begin a second study period in which they will continue with the intervention first received but shall add the intervention not initially received. While there are hundreds of studies that describe the adverse health and safety effects of night shift work, there are few studies where interventions are tested for their efficacy to reduce the harm to workers or improve their well-being. Currently the few intervention studies that exist focus on the scheduling, duration and timing of work shifts, the timing of meals, and aspects of lighting in the workplace. Other interventions, such as those proposed in this study, have not been tested systematically using a rigorous design. Purpose and Methods: The purpose of this study, using a cluster cross-over randomized trial design, is to measure the impact on professional quality of life (primary endpoint) and medication administration error, role-related meaning, and sleep quality (secondary endpoints) of either a mindfulness intervention plus sleep hygiene (Arm A) or a physical activity intervention plus sleep hygiene (Arm B) in the first study period, and the combination of both interventions on the same outcomes in the second study period for nightshift health care employees.

COMPLETED
The Professional Peer Resilience Initiative
Description

The Professional Peer Resilience Initiative (PPRI) study is an observational study aimed at understanding how symptoms of traumatic stress and resilience evolve over time in the University of Minnesota (UMN) healthcare workforce during the coronavirus disease 2019 (COVID-19) pandemic. The study is being conducted concurrently with a UMN peer support program called the MinnRAP program and will remotely administer quality of life and mental health surveys to healthcare workers before they start the MinnRAP program and throughout their participation in the program.

COMPLETED
Asynchronous Mindfulness Based Stress Reduction to Reduce Burnout in Licensed Clinical Social Workers
Description

This is a quasi-experimental study that will examine whether mindfulness based stress reduction, adapted to an online learning management system, will reduce factors related to burnout in private practice licensed clinical social workers in New York State.

COMPLETED
Summative Assessment of the BurntOut 3D Simulation With Medical Students
Description

Burnout is a common problem for medical students and is associated with stress-related health problems and also potentially affects the quality of care delivered to their patients. Among the health problems commonly associated with burnout are substance use problems, and alcohol is the substance most often misused. The purpose of the evaluation is to document whether an educational intervention incorporating aspects of virtual reality (VR) via a 3D online simulation experience prevents or improves the primary endpoint of burnout and the secondary endpoints of burnout-related factors in medical students. The investigators will also will evaluate student satisfaction with the intervention to determine if it meets our standard of success. The hypothesis is that the intervention will improve the primary clinical endpoint of burnout from pre-intervention to post-intervention as measured by the Maslach Burnout Inventory, a validated inventory that is widely used to measure burnout. The related factors that will be measured as secondary clinical endpoints include quality of life, substance use (alcohol and drugs), depression, and resilience. Due to evidence that these endpoints are linked to burnout, the investigators also hypothesize that the measures will improve pre- to post-intervention. Satisfaction of the target audience after completing the simulation intervention will also be evaluated. The evaluation will be prior to and after use of the simulation by medical student participants, using a pre-/post intervention, wait-list control, parallel design.

COMPLETED
Sleep Bootcamp: A Pilot Tele-Sleep Program for Former National Football League (NFL) Players
Description

This pilot study is focused on estimating the impact of a tele-sleep intervention on patient-centered outcomes relevant to former football players, including a) sleep duration, quality, and daytime impairment; b) pain, pain catastrophizing, physical and emotional functioning; c) mood; d) quality of life, with the longer-term goal to evaluate the impact on cardiovascular health risk. The evidence-based 'Brief Behavioral Therapy for Insomnia' (BBTI) will be utilized and tailored it to meet the needs of former football players. This pilot work will serve as the foundation for a larger, future clinical trial that utilizes a durable approach for improving sleep health with potential influence pain and quality of life as well as future studies to evaluate the implementation and scalability of BBTI in novel populations.

COMPLETED
Helping Invested Families Improve Veterans Experiences Study
Description

The purpose of this study is to evaluate a caregiver skill training program (HI-FIVES), offered as a part of a randomized control trial to caregivers of Veterans referred to home and community-based long-term care. Of primary interest is to examine whether participating in HI-FIVES leads to clinically significant increases in days spent at home for Veterans compared to caregivers in usual care. The investigators aim, through the training, to decrease the number of days over 12 months post-intervention that Veterans spend in the emergency department, hospital, or nursing home. Days spent in these settings reduces the Veteran's quality of life and increases health care costs to the VA. The investigators also will evaluate whether caregivers in HI-FIVES have clinically significant reductions in depressive symptoms post-intervention compared to caregivers in usual care.

COMPLETED
Intervention to Improve Care at Life's End
Description

The BEACON trial (Best Practices for End-of-Life Care for Our Nations' Veterans) was a six-site implementation study to evaluate a multi-component, education-based intervention to improve the quality of end-of-life care provided in VA Medical Centers.