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Peer Support for Exercise in Older Veterans With Psychotic Disorders

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ClinicalTrials.gov Identifier: NCT02958007
Recruitment Status : Recruiting
First Posted : November 8, 2016
Last Update Posted : November 14, 2018
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

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.

Condition or disease Intervention/treatment Phase
Psychotic Disorder Behavioral: Peer Education on Exercise for Recovery Behavioral: Enhanced supervised fitness training Not Applicable

Detailed Description:

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=50) 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 : Interventional  (Clinical Trial)
Estimated Enrollment : 56 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Peer Support for Exercise in Older Veterans With Psychotic Disorders
Actual Study Start Date : June 1, 2018
Estimated Primary Completion Date : November 30, 2021
Estimated Study Completion Date : May 31, 2022

Resource links provided by the National Library of Medicine


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
Behavioral: 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

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
Behavioral: 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




Primary Outcome Measures :
  1. Intervention engagement [ Time Frame: 12 weeks ]
    Percent of participants randomized to PEER who attend at least three group sessions

  2. Intervention fidelity [ Time Frame: 12 weeks ]
    Percent of sampled PEER group sessions in which the peer coaches were adequately adherent (i.e., average score equal to "acceptable" and no items scored as "unacceptable") on the PEER fidelity measure

  3. Attendance- mean number of supervised fitness training sessions attended [ Time Frame: 12 weeks ]
    Attendance- mean number of supervised fitness training sessions attended

  4. Change from baseline in Ambulatory Physical Activity [ Time Frame: 12 weeks ]
    Weekly step-counts will be measured by pedometer

  5. Change from baseline in Maximal Aerobic Capacity (Vo2Max) [ Time Frame: 12 weeks ]
    Maximum rate of oxygen consumption as measured during incremental exercise on a motorized treadmill



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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  • 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
  • inability to complete the Graded Exercise Treadmill Test
  • positive cardiac stress test, unless symptomatic coronary artery disease is ruled out by imaging studies
  • problematic substance abuse/dependence
  • imminent risk of suicidal or homicidal behavior
  • lack of capacity to consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02958007


Contacts
Contact: Anjana Muralidharan, PhD (410) 637-1872 Anjana.Muralidharan2@va.gov

Locations
United States, Maryland
Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD Recruiting
Baltimore, Maryland, United States, 21201
Contact: Anjana Muralidharan, PhD    410-637-1872    Anjana.Muralidharan2@va.gov   
Principal Investigator: Anjana Muralidharan, PhD         
Sponsors and Collaborators
VA Office of Research and Development
Investigators
Principal Investigator: Anjana Muralidharan, PhD Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD

Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT02958007     History of Changes
Other Study ID Numbers: D2339-W
1IK2RX002339-01A1 ( U.S. NIH Grant/Contract )
First Posted: November 8, 2016    Key Record Dates
Last Update Posted: November 14, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Additional relevant MeSH terms:
Disease
Mental Disorders
Psychotic Disorders
Pathologic Processes
Schizophrenia Spectrum and Other Psychotic Disorders