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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
Sponsor:
Information provided by (Responsible Party):
Dawn M. Bravata, VA Quality Enhancement Research Intiative

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.

Condition or disease Intervention/treatment Phase
Quality of Life Behavioral: Crossroads Orchestra Participatory Music Program Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Non-Randomized
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
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


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.
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.



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.


Other Outcome Measures:
  1. 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")

  2. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT03653130


Contacts
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Contact: Aimee N Lillie, B.S. 317-988-9712 aimee.lillie@va.gov

Locations
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United States, Indiana
VA Domiciliary Recruiting
Indianapolis, Indiana, United States, 46216
Contact: Aimee N Lillie, B.S.    317-988-9712    aimee.lillie@va.gov   
Principal Investigator: Dawn M Bravata, MD         
Sponsors and Collaborators
VA Quality Enhancement Research Intiative
Investigators
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Principal Investigator: Dawn M Bravata, MD VA Quality Enhancement Research Initiative

Additional Information:
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Responsible Party: Dawn M. Bravata, Professor of Medicine and Adjunct Professor of Neurology, VA Quality Enhancement Research Intiative
ClinicalTrials.gov Identifier: NCT03653130     History of Changes
Other Study ID Numbers: 1802361597
First Posted: August 31, 2018    Key Record Dates
Last Update Posted: August 31, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Dawn M. Bravata, VA Quality Enhancement Research Intiative:
homeless
recreational therapy
community integration
reintegration
Veteran
housing insecurity
Domiciliary
Human Occupation
Occupational therapy
Music