Quality of LifeNCT03653130
Participatory Music Program for Homeless Veterans
A study testing Crossroads Orchestra Participatory Music Program in people with Quality of Life, run by VA Quality Enhancement Research Intiative at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Quality of Life
- What is being tested?
- Crossroads Orchestra Participatory Music Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Jul 2018to 18 Jun 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- Visual impairment (blindness)
- Profound hearing impairment (deafness)
- Cognitive impairment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Participatory Music Program for Homeless Veterans (Crossroads Orchestra): Pilot Evaluation
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.
Read the 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.
- Conditions
- Quality of Life
- Being tested
- Crossroads Orchestra Participatory Music Program
- Keywords
- homeless, recreational therapy, community integration, reintegration, Veteran, housing insecurity, Domiciliary, Human Occupation, Occupational therapy, Music
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Crossroads Orchestra Participatory Music ProgramBehavioural
The intervention is a participatory music program where adults engage in music-making as members of a strings orchestra.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: change from baseline to month-6
Secondary outcomes (1)
Community Reintegration: Military to Civilian Questionnaire (M2C-Q)
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.
Measured: 1 month post-transition
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2018
- Study start18 Jul 2018
- Primary completion18 Jun 2019
- Study completion18 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Quality of LifeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Quality Enhancement Research Intiative
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dawn M. Bravata, VA Quality Enhancement Research Intiative
- Investigators
- Dawn M Bravata, MD, Principal investigator, VA Quality Enhancement Research Initiative
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03653130
- Sponsor's protocol ID
- 1802361597
- Status last verified
- Sep 2019
- First submitted
- 21 Aug 2018
- Last updated
- 10 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Participatory Music Program for Homeless Veterans (Crossroads Orchestra): Pilot Evaluation
- ClinicalTrials.gov ID
- NCT03653130
- Acronym / sponsor ID
- 1802361597
- Conditions
- Quality of Life
- Keywords
- homeless, recreational therapy, community integration, reintegration, Veteran, housing insecurity, Domiciliary, Human Occupation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- VA Quality Enhancement Research IntiativeUniversity, hospital or other
- Study start
- 18 Jul 2018 (actual)
- Primary completion
- 18 Jun 2019 (actual)
- Study completion
- 18 Jun 2019 (actual)
- First posted
- 31 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intervention Program | Experimental | Behavioral: Crossroads Orchestra Participatory Music ProgramParticipants 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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)
Key exclusion criteria (3 listed)
- Visual impairment (blindness)
- Profound hearing impairment (deafness)
- Cognitive impairment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Crossroads Orchestra Participatory Music ProgramThe intervention is a participatory music program where adults engage in music-making as members of a strings orchestra. | Behavioural | Intervention Program |
Primary outcome
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.
1 secondary outcome
Community Reintegration: Military to Civilian Questionnaire (M2C-Q)
Time frame: 1 month post-transition
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2019.
- Keiper S, Sandene, B.A., Persky, H.R., and Kuang, M. . The Nation's Report Card: Arts 2008 Music \& Visual Arts (NCES 2009-488). In: National Center for Education Statistics IoES, U.S. Department of Education, ed. Washington, D.C.2009.Link provided by the sponsor.
- Ending Veteran Homelessness: A Community by Community TallyLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dawn M Bravata, MD principal investigator
VA Quality Enhancement Research Initiative
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Crossroads Orchestra Participatory Music Program in people with Quality of Life, run by VA Quality Enhancement Research Intiative at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of Life: 20-Item Short Form Health Survey (SF-20) (time frame: change from baseline to month-6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2019.