Participatory Music Program for Homeless Veterans
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|ClinicalTrials.gov Identifier: NCT03653130|
Recruitment Status : Recruiting
First Posted : August 31, 2018
Last Update Posted : August 31, 2018
|Condition or disease||Intervention/treatment||Phase|
|Quality of Life||Behavioral: Crossroads Orchestra Participatory Music Program||Not Applicable|
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.
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 :||Interventional (Clinical Trial)|
|Estimated Enrollment :||240 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||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.|
|Masking:||None (Open Label)|
|Masking Description:||No masking|
|Official Title:||Participatory Music Program for Homeless Veterans (Crossroads Orchestra): Pilot Evaluation|
|Actual Study Start Date :||July 18, 2018|
|Estimated Primary Completion Date :||January 2019|
|Estimated Study Completion Date :||January 2019|
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.
Behavioral: Crossroads Orchestra Participatory Music Program
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.
- 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.
- 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.
- 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")
- 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.
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): NCT03653130
|Contact: Aimee N Lillie, B.S.||email@example.com|
|United States, Indiana|
|Indianapolis, Indiana, United States, 46216|
|Contact: Aimee N Lillie, B.S. 317-988-9712 firstname.lastname@example.org|
|Principal Investigator: Dawn M Bravata, MD|
|Principal Investigator:||Dawn M Bravata, MD||VA Quality Enhancement Research Initiative|