- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03653130
Participatory Music Program for Homeless Veterans
Participatory Music Program for Homeless Veterans (Crossroads Orchestra): Pilot Evaluation
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
SPECIFIC AIMS:
Aim 1: To evaluate the effectiveness of the participatory music program in terms of improving quality of life.
Aim 2: To evaluate the effect of the participatory music program on community reintegration. Veteran members of the Crossroads Orchestra program may develop a sense of participating in something that "is bigger than oneself." They may develop a new sense of self, or identify with a new role. They may develop a sense of commitment to their stand-partner. These positive new perspectives may facilitate their transition from the Domiciliary to the community. Semi-structured interviews with participants will be conducted to understand participants' experiences to both improve the program and to assess its effects. The Military to Civilian Questionnaire (M2C-Q) measure will be used to assess community reintegration.
Secondary Aim: To evaluate the effect of the participatory music program on healthcare utilization. This pilot project is not powered to identify statistically significant differences in healthcare utilization but rather is designed to provide preliminary data to understand the potential role of a music education and orchestra participation experience for improving outcomes among Veteran participants.
INTERVENTION DESCRIPTION:
The intervention is a participatory music program where adults engage in music-making as members of a strings orchestra. As part of the Crossroads Orchestra, participants will receive an instrument (violin, viola, or cello). The intervention sessions will take place twice a week at the Domiciliary and once per week at either the Domiciliary or other Indianapolis community location. 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. The choice of music pieces will be made by the interventionist in consultation with participants (to ensure that the choices represent selections that are most engaging for the majority of participants). The participants will be given a binder with sheet music and practice logs. The music educator will create Youtube videos demonstrating violin, viola, and cello techniques and providing helpful tips. Participants will be encouraged to practice and to attend all of the group sessions.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Indiana
-
Indianapolis, Indiana, United States, 46216
- VA Domiciliary
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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)
Exclusion Criteria:
- Visual impairment (blindness)
- Profound hearing impairment (deafness)
- Cognitive impairment
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention Program
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.
|
The intervention is a participatory music program where adults engage in music-making as members of a strings orchestra.
|
|
No Intervention: Usual Care Control
Usual care at VA Domiciliary including participation in Domiciliary recreational therapy electives (if eligible).
|
|
|
No Intervention: Retrospective Chart Review
Retrospective chart reviews case-matched to intervention participants for age and biological sex factors.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Quality of Life: 20-Item Short Form Health Survey (SF-20)
Time Frame: change from baseline to month-6
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Community Reintegration: Military to Civilian Questionnaire (M2C-Q)
Time Frame: 1 month post-transition
|
We will use the M2C-Q measure to assess perceived difficulties reintegrating into community life after leaving the Domiciliary.
This is a 16 item scale where each item is scored on a 5-point Likert scale with 0 representing no difficulty and 4 representing extreme difficulty with reintegration.
|
1 month post-transition
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Healthcare Utilization: Chart Review
Time Frame: One-year pre-enrollment versus the one-year post-enrollment period
|
Healthcare utilization includes ED visits, inpatient admissions, and clinic missed appointments ("no shows")
|
One-year pre-enrollment versus the one-year post-enrollment period
|
|
Flow State (Experience of Total Absorption): Flow State Scale (FSS-2)
Time Frame: month-6
|
Flow state describes a participant's engagement with the intervention.
The FSS-2 includes 9 items that are scored from 1 (disagree) to 5 (strongly agree).
Higher scores indicate a greater degree of task absorption.
|
month-6
|
Collaborators and Investigators
Investigators
- Principal Investigator: Dawn M Bravata, MD, VA Quality Enhancement Research Initiative
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 1802361597
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.