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Peer Support for Exercise in Older Veterans With Psychotic Disorders

Primary Purpose

Psychotic Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Peer Education on Exercise for Recovery
Enhanced supervised fitness training
Sponsored by
VA Office of Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Psychotic Disorder

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Peer Education on Exercise for Recovery

Enhanced supervised fitness training

Arm Description

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 intervention to promote participation in a supervised fitness training program and general physical activity, which includes individual support from non-peer staff

Outcomes

Primary Outcome Measures

Intervention Engagement
Percent of participants randomized to PEER who attend at least three group sessions
Intervention Fidelity
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.
Attendance
Attendance- mean number of supervised fitness training sessions attended

Secondary Outcome Measures

Full Information

First Posted
November 2, 2016
Last Updated
November 29, 2022
Sponsor
VA Office of Research and Development
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1. Study Identification

Unique Protocol Identification Number
NCT02958007
Brief Title
Peer Support for Exercise in Older Veterans With Psychotic Disorders
Official Title
Peer Support for Exercise in Older Veterans With Psychotic Disorders
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
June 1, 2018 (Actual)
Primary Completion Date
November 30, 2021 (Actual)
Study Completion Date
May 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Older adults with psychotic disorders experience a dual set of challenges: those related to serious mental illness, and those related to aging. They have medical, cognitive, psychological and social difficulties; as a result they have an almost four times greater likelihood of early institutionalization in nursing homes. These challenges make it difficult for this group to engage in health behaviors, such as exercise. This is unfortunate, since participation in health-promoting activities is essential for maintaining functional independence with age. This study aims to develop and pilot test a peer coaching intervention for older Veterans with psychotic disorders, in which VA Peer Specialists, who are Veterans in recovery from mental illness, will provide intensive coaching to older Veterans with psychotic disorders to promote their participation in exercise and physical activity. Results from this study will inform us as to whether this intervention is acceptable to Veterans, feasible to implement, and effective in increasing exercise, physical activity, and physical fitness/function.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psychotic Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
22 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Peer Education on Exercise for Recovery
Arm Type
Experimental
Arm Description
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
Arm Title
Enhanced supervised fitness training
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Behavioral
Intervention Name(s)
Peer Education on Exercise for Recovery
Intervention Description
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
Intervention Type
Behavioral
Intervention Name(s)
Enhanced supervised fitness training
Intervention Description
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
Primary Outcome Measure Information:
Title
Intervention Engagement
Description
Percent of participants randomized to PEER who attend at least three group sessions
Time Frame
12 weeks
Title
Intervention Fidelity
Description
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.
Time Frame
12 weeks
Title
Attendance
Description
Attendance- mean number of supervised fitness training sessions attended
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anjana Muralidharan, PhD
Organizational Affiliation
Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
Official's Role
Principal Investigator
Facility Information:
Facility Name
Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Peer Support for Exercise in Older Veterans With Psychotic Disorders

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