Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT02958007 |
| Other study ID # |
D2339-W |
| Secondary ID |
1IK2RX002339-01A |
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
June 1, 2018 |
| Est. completion date |
May 31, 2022 |
Study information
| Verified date |
November 2022 |
| Source |
VA Office of Research and Development |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
