NCT03653130

Brief Summary

This pilot project evaluates the effectiveness of a participatory music program for Veterans cared for in the Domiciliary Care for Homeless Veterans (DCHV) Program (Indianapolis, IN) in terms of improving quality of life. A secondary goal of this study is to evaluate the effect of the participatory music program on community reintegration and healthcare utilization. The participatory music program entitled the "Crossroads Orchestra" includes both music education and an orchestra experience. The objective of this intervention program is to use an engaging music-based education and group orchestra experience to provide participants with an avocation that will improve their quality of life and facilitate their reintegration into the community. The Crossroads Orchestra pilot project protocol has been grounded on concepts from occupational therapy and recreational therapy; specifically, providing participants with a meaningful new activity that is enjoyable, that can be provided across a spectrum of skill levels (e.g., for participants with no musical training as well as for individuals who are proficient strings musicians), and that can provide participants with a new sense of self.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
180

participants targeted

Target at P75+ for not_applicable quality-of-life

Timeline
Completed

Started Jul 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 18, 2018

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 21, 2018

Completed
10 days until next milestone

First Posted

Study publicly available on registry

August 31, 2018

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 18, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 18, 2019

Completed
Last Updated

September 10, 2019

Status Verified

September 1, 2019

Enrollment Period

11 months

First QC Date

August 21, 2018

Last Update Submit

September 9, 2019

Conditions

Keywords

homelessrecreational therapycommunity integrationreintegrationVeteranhousing insecurityDomiciliaryHuman OccupationOccupational therapyMusic

Outcome Measures

Primary Outcomes (1)

  • Quality of Life: 20-Item Short Form Health Survey (SF-20)

    We will examine the trajectory of quality of life scores over time utilizing the SF-20. The total score ranges from 0-100, higher values indicate better functioning.

    change from baseline to month-6

Secondary Outcomes (1)

  • Community Reintegration: Military to Civilian Questionnaire (M2C-Q)

    1 month post-transition

Other Outcomes (2)

  • Healthcare Utilization: Chart Review

    One-year pre-enrollment versus the one-year post-enrollment period

  • Flow State (Experience of Total Absorption): Flow State Scale (FSS-2)

    month-6

Study Arms (3)

Intervention Program

EXPERIMENTAL

Participants will receive an instrument (violin, viola, or cello). Intervention sessions will take place twice a week at the Domiciliary and once per week at the Domiciliary or at a community location (Richard L. Roudebush VA Medical Center or Regenstrief Institute). Each session will include: thirty minutes of group music instruction by an experienced music educator with skills in adult music education followed by thirty minutes of weekly adult ensemble experience.

Behavioral: Crossroads Orchestra Participatory Music Program

Usual Care Control

NO INTERVENTION

Usual care at VA Domiciliary including participation in Domiciliary recreational therapy electives (if eligible).

Retrospective Chart Review

NO INTERVENTION

Retrospective chart reviews case-matched to intervention participants for age and biological sex factors.

Interventions

The intervention is a participatory music program where adults engage in music-making as members of a strings orchestra.

Intervention Program

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Residents of the Indianapolis VA Domiciliary who are eligible to participate in elective activities (i.e., they have been Domiciliary residents for a minimum of two weeks and they have not committed any infractions that would place them on restriction status)

You may not qualify if:

  • Visual impairment (blindness)
  • Profound hearing impairment (deafness)
  • Cognitive impairment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA Domiciliary

Indianapolis, Indiana, 46216, United States

Location

Related Links

Study Officials

  • Dawn M Bravata, MD

    VA Quality Enhancement Research Initiative

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Masking Details
No masking
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Parallel Interventional Study Model: Intervention participants (N=40) and usual care controls (N=40) will be eligible if they are residents of the Indianapolis VA Domiciliary who are eligible to participate in elective activities at the time of recruitment. Intervention participants will include eligible Veterans who agree to participate in the intervention. Usual Care Controls will include eligible Veterans who agree to complete the interviews and measures, but do not agree to participate in the participatory music program. Records for retrospective chart review (N=160) will be selected from past Domiciliary residents based on case-matching for gender and biological sex factors with intervention participants.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Medicine and Adjunct Professor of Neurology

Study Record Dates

First Submitted

August 21, 2018

First Posted

August 31, 2018

Study Start

July 18, 2018

Primary Completion

June 18, 2019

Study Completion

June 18, 2019

Last Updated

September 10, 2019

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will not share

Locations