Peer Support for Exercise in Older Veterans With Psychotic Disorders

NCT02958007 | Completed Results

• 2 other identifiers: D2339-W1IK2RX002339-01A1
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Psychotic Disorder

Outcome Measures

Primary Outcomes (3)

• Intervention Engagement

  Percent of participants randomized to PEER who attend at least three group sessions

  12 weeks

• 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.

  12 weeks

• Attendance

  Attendance- mean number of supervised fitness training sessions attended

  12 weeks

Study Arms (2)

Peer Education on Exercise for Recovery

EXPERIMENTAL

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

Behavioral: Peer Education on Exercise for Recovery

Enhanced supervised fitness training

ACTIVE COMPARATOR

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

Behavioral: Enhanced supervised fitness training

Interventions

Peer Education on Exercise for Recovery BEHAVIORAL

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

Peer Education on Exercise for Recovery

Enhanced supervised fitness training BEHAVIORAL

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

Enhanced supervised fitness training

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

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

Baltimore, Maryland, 21201, United States

Location

MeSH Terms

Conditions

Psychotic Disorders

Interventions

Salvage Therapy

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Therapeutics

Limitations and Caveats

Due to COVID, this trial was shut down partway through for one year. The second half of the trial was conducted in a hybrid model, with all aspects of the study being conducted virtually except gym attendance. Due to this loss of time, the sample size was smaller than originally intended.

Results Point of Contact

• Title: Anjana Muralidharan
• Organization: VA Maryland Healthcare System

anjana.muralidharan2@va.gov

443-421-6275

Study Officials

• Anjana Muralidharan, PhD

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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 2016
• First Posted: November 8, 2016
• Study Start: June 1, 2018
• Primary Completion: November 30, 2021
• Study Completion: May 31, 2022
• Last Updated: September 25, 2023
• Results First Posted: September 25, 2023

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)