- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02958007
Peer Support for Exercise in Older Veterans With Psychotic Disorders
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Project was modified to minimize risk of exposure to COVID-19. Sample size was reduced due to loss of time due to pandemic restrictions.
Anticipated Impacts on Veteran's Healthcare: Older Veterans with psychotic disorders face unique barriers to engagement in health-promoting activities, including prototypical features of psychosis (e.g., negative symptoms, medication side effects) and exacerbating features of the aging process (e.g., increased medical comorbidity, declines in musculoskeletal health). It is critical to develop strategies to empower this group to overcome these barriers and engage in health behaviors that can improve their functioning and quality of life. Peer interventions, or interventions delivered by individuals who are similar to a patient population on some characteristic such as age or diagnosis, effectively promote engagement in health behaviors in a range of populations. Despite the promise of peer support and urgent needs of older adults with psychosis, there are no well-specified peer support interventions that promote participation in health behaviors and are tailored to the needs of this group. The present study will yield a well-specified group-based peer coaching intervention, to be delivered by VA Peer Specialists (Veterans in recovery from mental illness), targeted to empower older Veterans with psychosis to overcome barriers, increase exercise/physical activity, and improve functioning.
Project Background: Over the next two decades, Veterans with psychotic disorders (i.e., schizophrenia spectrum disorders and affective psychoses) will age into older adulthood in unprecedented numbers. The challenges of treating this growing population and associated high costs will have profound implications for VHA. Older adults with psychotic disorders exhibit diminished physical and psychosocial functioning and are at increased risk for rapid functional decline and early institutionalization in nursing homes. Participation in structured exercise delays functional disability in older adults; however, older adults with psychosis exhibit low exercise participation. While peer-delivered exercise interventions for older adults promote initiation and maintenance of exercise and physical activity, there are no peer-delivered exercise interventions tailored to the unique needs of older adults with psychosis. The present study aims to fill this critical gap.
Project Objectives: This study will develop and pilot test a well-specified, group-based peer coaching intervention tailored to the unique needs of older Veterans with psychotic disorders: Peer Education on Exercise for Recovery (PEER). PEER will provide intensive coaching from a VA Peer Specialist to promote participation in a supervised fitness training program for older Veterans. To develop the intervention, materials from existing peer-delivered wellness interventions for Veterans with serious mental illness will be tailored for older Veterans with psychosis, through an iterative process synthesizing the extant literature and pilot data, developing draft materials, and obtaining feedback from a multidisciplinary panel of expert mentors/consultants and Peer Specialists/Veteran consumers. A small open trial of PEER will be conducted with 6 older Veterans with psychotic disorders (ages 50 and up); qualitative interviews will explore participants' perceptions of PEER. Finally, a pilot randomized controlled trial (RCT) of PEER will be conducted. Older Veterans with psychotic disorders (ages 50 and up, n=22) will be enrolled in supervised fitness training and randomized to receive group-based peer coaching (the PEER condition) or individual support from non-peer staff (the enhanced supervised fitness training (ESFT) condition). Feasibility of PEER (rates of recruitment, intervention engagement, and peer coach fidelity) will be measured. The impact of PEER versus ESFT on attendance of exercise sessions, levels of physical activity, and physical functioning will be examined. Additionally, the PI will engage in training activities to develop expertise in the functional rehabilitation of older adults with psychosis.
Project Methods: This project will include developing intervention materials for PEER, conducting an open trial of PEER in a small sample, and completing a small RCT. The investigators will monitor acceptability and feasibility; study Veterans' experiences; and measure exercise/physical activity behaviors and functional outcomes.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Maryland
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Baltimore, Maryland, United States, 21201
- Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Current diagnosis of a psychotic disorder, meeting criteria established by the VA Serious Mental Illness Treatment Research and Evaluation Center (SMITREC): schizophrenic disorders (295.0-295.9), affective psychoses (296.0-296.1, 296.4-296.8), or major depression with psychotic features (296.24, 296.34)
- age 50 or older
- participation in mental health services at the VA Maryland Healthcare System
- sufficient clinical stability to participate as deemed by a mental health treatment provider and/or chart review
- sufficient medical stability as deemed by a medical provider
Exclusion Criteria:
- Current participation in a supervised exercise program
medical conditions which would preclude exercise participation including:
- unstable angina
- proliferative diabetic retinopathy
- oxygen dependence
- frank incontinence
- open wounds
- poorly controlled Type 2 diabetes (HbA1c > 9%)
- current treatment for active cancer
- New York Heart Association Stage II-IV heart failure
- dialysis for chronic kidney disease
- myocardial infarction in the previous three months
- problematic substance abuse/dependence
- imminent risk of suicidal or homicidal behavior
- lack of capacity to consent
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Peer Education on Exercise for Recovery
A 24-week group-based peer coaching intervention delivered by a VA Peer Specialist, to promote participation in a supervised fitness training program and general physical activity
|
A 24-week group-based peer coaching intervention delivered by a VA Peer Specialist, to promote participation in a supervised fitness training program and general physical activity
|
Active Comparator: Enhanced supervised fitness training
A 24-week intervention to promote participation in a supervised fitness training program and general physical activity, which includes individual support from non-peer staff
|
A 24-week intervention to promote participation in a supervised fitness training program and general physical activity, which includes individual support from non-peer staff
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Intervention Engagement
Time Frame: 12 weeks
|
Percent of participants randomized to PEER who attend at least three group sessions
|
12 weeks
|
Intervention Fidelity
Time Frame: 12 weeks
|
Percent of sampled PEER group sessions in which the peer coaches were adequately adherent, as per the PEER Fidelity Measure.
This measure includes content items (e.g., "How well did facilitators review the educational topic of the day") and process items (e.g., "How well did facilitators provide positive feedback and reinforcement throughout the class?")
Each item is rated as 0 (unacceptable), 1 (acceptable), or 2 (excellent), and then an average score is calculated.
Adequate adherence was defined as an average score of 1 or greater and no items rated as unacceptable.
|
12 weeks
|
Attendance
Time Frame: 12 weeks
|
Attendance- mean number of supervised fitness training sessions attended
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12 weeks
|
Collaborators and Investigators
Investigators
- Principal Investigator: Anjana Muralidharan, PhD, Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- D2339-W
- 1IK2RX002339-01A1 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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