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Heart FailureNCT06546319

Music Therapy to Address Patients' Journeys With Chronic Illness, Outcomes, and Readmission - MAJOR CHORD RCT

A study testing Music Therapy in people with Heart Failure and Chronic Obstructive Pulmonary Disease, run by Samuel Rodgers-Melnick at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Conduct a randomized trial (n = 60: with n = 30 receiving music therapy and n = 30 receiving usual care) to investigate the feasibility, acceptability, and preliminary efficacy of the MAJOR CHORD music therapy intervention compared to usual care on (a) health-related quality of life (e.g., physical function… Read more about this study

Who is it for?
Ages 30 to 89 years
What is being tested?
Music Therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteUnited States
Study dates
26 Aug 2024to 17 Jun 2025
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 30 to 89 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age range: ≥30 to ≤89 years
  • Primary indication for current hospitalization is either COPD or HF with confirmed ICD-10 code in the electronic health record (EHR)
  • Able to read and understand English
  • Hospitalized at UH Cleveland Medical Center (UHCMC) with anticipated length of stay following recruitment ≥ 2 days as documented in electronic health record (EHR) and confirmed by the clinical care team
  • Access to Wi-Fi, active email address, \& laptop, tablet, smartphone, and/or PC with videoconferencing capabilities at home or the facility in which they will be discharged
  • Has reliable access to a mobile device with an active data plan at the hospital and at home and is comfortable accessing the internet and their email with this device
  • Qualitative Interview Inclusion Criteria 1. Agreed to be contacted for the qualitative interview during contenting process for the RCT

Who cannot join

  • Active confirmed or suspected COVID-19, or under droplet, contact, MRSA, and/or C.diff precaution notification as documented in the EHR
  • Included on the Music Therapy Referral patient list in the EHR
  • Significant hearing and/or visual impairment as documented in EHR
  • Unable to independently provide consent (i.e., no proxy consent)
  • Active suicidal ideation as documented in EHR during current hospital admission
  • Severe psychological comorbidity (e.g., psychosis, schizophrenia) that would prevent patient from engaging fully in intervention as documented in EHR
Show all 15Show fewer
  • Receiving active cancer treatment (e.g., chemotherapy, radiation, immunotherapy) as documented in EHR
  • Diagnosed with medical condition likely to be terminal within 24 weeks as documented in EHR
  • On wait list for heart transplantation or ventricular assist device (VAD) as documented in EHR
  • NYHA Stage IV HF or end-stage COPD as documented in EHR
  • Receiving hospice care as documented in EHR
  • Active substance abuse as documented in EHR
  • Has end stage renal disease or is currently receiving dialysis
  • Qualitative Interview Exclusion Criteria
  • 1. Randomized to the control arm

Trial locations and contacts

1 site in 1 country.

United States1 site
  • University Hospitals Cleveland Medical Center

    Cleveland, Ohio, 44106

Other trials in United States

About this study

Official title: Music Therapy to Address Patients' Journeys With Chronic Illness, Outcomes, and Readmission (MAJOR CHORD RCT): A Randomized Controlled Trial

Conduct a randomized trial (n = 60: with n = 30 receiving music therapy and n = 30 receiving usual care) to investigate the feasibility, acceptability, and preliminary efficacy of the MAJOR CHORD music therapy intervention compared to usual care on (a) health-related quality of life (e.g., physical function, depression, anxiety, fatigue, and pain interference), (b) perceived stress, (c) self-efficacy, and (d) 30-day readmission rates

Read the detailed description

For the intervention arm, in-person sessions will be conducted at the discretion of the music therapist and at a convenient time for the participant. Post-discharge music therapy sessions will be conducted virtually via secure telehealth platform (i.e., Zoom for Healthcare) with participants at home, skilled nursing facility, or in the hospital, if readmitted, while the music therapist is stationed at UHCMC or another UH facility in a private location. Reminder phone calls and MyCap messages will be completed one day prior to the scheduled virtual session. Links to the virtual session will be sent at the time of scheduling and again just prior to the session.

For both arms, follow-up measures will be completed using REDCap surveys sent via Twilio text message at 15- and 30-days following the hospital discharge date. REDCap will be used to collect the PROMIS - 29, Perceived Stress Scale - 4 (PSS-4), PROMIS General Self-Efficacy 4a, PROMIS Instrumental Support 4a, and PROMIS Emotional Support 4a scores at (1) Baseline, (2) 15-days post discharge, and (3) 30-days post discharge, with REDCap ensuring these are delivered on the nearest weekday rather than a weekend. Reminder texts will be sent out at day 16 \& 17 and day 31 \& 32 for those who do not complete their follow-up assessments following the initial prompt.

Board-certified music therapists (i.e., MT-BC credential) will provide two music therapy sessions, not to occur on the same day, that include education and disease-specific content (e.g., harmonica exercises for respiratory health [COPD] or music-based breathing exercises [HF]) prior to patients' discharge and two virtual music therapy sessions that address music-assisted relaxation and imagery, additional techniques for managing psychosocial stressors, and gratitude exercises post-discharge. Each music therapy session will include (1) setting an agenda; (2) an explanation of the music exercise; (3) a demonstration of the music exercise in which the MT-BC will engage the participant in practicing the music exercise (e.g., breathing, imagery, harmonica exercise); (4) time to process the participant's response to the exercise; (5) time for the MT-BC to electronically deliver the music exercise to the participant and ensure that the participant has all materials necessary to use the exercise at home; and (6) a homework assignment for the participant to practice the music exercise taught in that session at least once per day until the following MT session. The genres of each music exercise will be personalized to participants' preferences (e.g., hip-hop, gospel, R\&B, jazz, rock, and/or soul). Each music exercise will last an average of 12 minutes. As the music exercises are being demonstrated, the MT-BC will simultaneously record the exercise as it is being delivered live. These recordings will be created in a high-quality recording studio, using either (1) a mobile unit in the participant's hospital room during in-person sessions or (2) a virtual music therapy studio at UH Cleveland Medical Center or the music therapist's private office at another UH facility during virtual sessions while participants are at home or in a care facility. The participant will hear the music live and receive a recording at the end of each session for their homework assignment. Each participant's voice may be recorded as part of the second virtual music therapy intervention (i.e., fourth of four sessions) which features a personalized songwriting intervention to which the patient can choose to contribute their voice. These recordings will be uploaded to a personalized UH Enterprise Box folder created for each participant. In-person MT sessions will be audio-recorded, and virtual sessions will be audio and video recorded through UH Zoom for Healthcare for quality assurance and fidelity checking. Recordings will be uploaded to a password-protected secure server and removed from recording devices. MT sessions will be reviewed for quality assurance for the first 5 participants and every 5th participant thereafter.

At the request of the participant, study staff may meet with the participant either in-person prior to discharge or virtually post-discharge to assist the participant in accessing Zoom and practicing the skills needed for videoconferencing (e.g., joining audio, muting, unmuting).

Participants will receive text message links every 7 days following the first music therapy session to log their home exercise activity.

The study staff will coordinate with the participant, participant's family and/or home care nursing team to facilitate the participant's engagement in virtual visits following discharge and before the first virtual music therapy session. The music therapist will provide instructions for virtual access and resources. The study staff will follow up with the participant following discharge to assist them with engaging in virtual music therapy post-discharge.

Being tested
Music Therapy
Keywords
Music Therapy, Chronic Obstructive Pulmonary Disease, Heart Failure, In-person, Virtual
Medical subject headings
Heart Failure, Pulmonary Disease, Chronic Obstructive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Music TherapyBehavioural

    Board-certified music therapists (i.e., MT-BC credential) will provide two music therapy sessions, not to occur on the same day, that include education and disease-specific content (e.g., harmonica exercises for respiratory health [COPD] or music-based breathing exercises [HF]) prior to patients' discharge and two virtual music therapy sessions that address music-assisted relaxation and imagery, additional techniques for managing psychosocial stressors, and gratitude exercises post-discharge.

Study groups in NCT06546319
Study groupRoleWhat they receive
Music TherapyExperimentalParticipants will complete a series of questionnaires after enrolling, 15 days post hospital discharge, and 30 days post hospital discharge. Board-certified music therapists (i.e., MT-BC credential) will provide two music therapy sessions, not to occur on the same day, that include education and disease-specific content (e.g., harmonica exercises for respiratory health [COPD] or music-based breathing exercises [HF]) prior to patients' discharge and two virtual music therapy sessions that address music-assisted relaxation and imagery, additional techniques for managing psychosocial stressors, and gratitude exercises post-discharge.
Receives: Behavioral: Music Therapy
ControlNo interventionNo additional intervention will be conducted for this arm during their study participation. Participants will complete a series of questionnaires after enrolling, 15 days post hospital discharge, and 30 days post hospital discharge. Participants randomized to the control arm will be offered a single virtual music therapy session after 30 days post-discharge. No data will be collected during this music therapy session.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Comparison of actual and anticipated recruitment rates

    Actual rates of recruitment as compared to the anticipated recruitment rate of at least 35% of those approached for the study.

    Measured: 30 days post discharge

  2. Comparison of actual and anticipated retention rates

    Actual rates of retention as compared to the anticipated retention rate of 70% of participants until the final survey time point.

    Measured: 30 days post discharge

  3. Comparison of actual and anticipated attendance rates

    Actual rates of attendance rates as compared to the anticipated 3/4 sessions among at least 70% of participants in the music therapy arm.

    Measured: 30 days post discharge

  4. Comparison of actual and anticipated completion rates

    Actual rates of completion rates as compared to the anticipated at least 70% of 15-day and 30-day follow-up measures.

    Measured: 30 days post discharge

  5. Number of participants report daily music exercise use

    At least 60% of participants in the music therapy arm reporting use of music exercises at least once every other day.

    Measured: 30 days post discharge

  6. Acceptance of music therapy intervention

    Favorable responses to qualitative interviews

    Measured: 37 days post discharge

Secondary outcomes (11)
  1. Change from baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function Short Form 4a

    Physical function (4 questions)

    Measured: Pre-test at baseline, 15 days post-discharge, and 30 days post-discharge

  2. Change from baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety Short Form 4a

    Anxiety (4 questions)

    Measured: Pre-test at baseline, 15 days post-discharge, and 30 days post-discharge

  3. Change from baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) Depression - Short Form 4a

    Depression (4 questions)

    Measured: Pre-test at baseline, 15 days post-discharge, and 30 days post-discharge

  4. Change from baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue - Short Form 4a

    Fatigue (4 questions)

    Measured: Pre-test at baseline, 15 days post-discharge, and 30 days post-discharge

  5. Change from baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance - Short Form 4a

    Sleep disturbance (4 questions)

    Measured: Pre-test at baseline, 15 days post-discharge, and 30 days post-discharge

  6. Change from baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) Ability to Participate in Social Roles and Activities - Short Form 4a

    Ability to participate in social roles and activities (4 questions)

    Measured: Pre-test at baseline, 15 days post-discharge, and 30 days post-discharge

  7. Change from baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference - Short Form 4a

    Pain interference (4 questions)

    Measured: Pre-test at baseline, 15 days post-discharge, and 30 days post-discharge

  8. Change from baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) General Self Efficacy - Short Form 4a

    General self-efficacy (4 questions)

    Measured: Pre-test at baseline, 15 days post-discharge, and 30 days post-discharge

  9. Change from baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) Emotional Support - Short Form 4a

    Emotional support (4 questions)

    Measured: Pre-test at baseline, 15 days post-discharge, and 30 days post-discharge

  10. Change from baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) Instrumental Support - Short Form 4a

    Instrumental support (4 questions)

    Measured: Pre-test at baseline, 15 days post-discharge, and 30 days post-discharge

  11. Change from baseline in Perceived Stress Scale - 4

    Perceived stress (4 questions)

    Measured: Pre-test at baseline, 15 days post-discharge, and 30 days post-discharge

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Aug 2024
  2. Study start26 Aug 2024
  3. Primary completion17 Jun 2025
  4. Study completion17 Jun 2025

Resources

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
Other
Allocation
Randomised
Intervention model
Parallel groups
Model description
This study will utilize a mixed-methods intervention design in which qualitative data are embedded in the framework of a randomized controlled trial. Participants receiving music therapy will be compared to participants in a waitlist control group.
Masking
None (open label)
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06546319
Sponsor's protocol ID
STUDY20240686
Status last verified
Aug 2025
First submitted
6 Aug 2024
Last updated
6 Aug 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Music Therapy in people with Heart Failure and Chronic Obstructive Pulmonary Disease, run by Samuel Rodgers-Melnick 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 7 inclusion and 15 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 6 Aug 2025. 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?

Comparison of actual and anticipated recruitment rates (time frame: 30 days post discharge). The study lists 6 primary outcomes in all. 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 6 Aug 2025.

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