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

NCT06546319 | Completed DMC

• 1 other identifier: STUDY20240686
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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, depression, anxiety, fatigue, and pain interference), (b) perceived stress, (c) self-efficacy, and (d) 30-day readmission rates

Conditions

Heart Failure; Chronic Obstructive Pulmonary Disease

Keywords

Music Therapy; Chronic Obstructive Pulmonary Disease; Heart Failure; In-person; Virtual

Outcome Measures

Primary Outcomes (6)

• 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.

  30 days post discharge

• 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.

  30 days post discharge

• 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.

  30 days post discharge

• 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.

  30 days post discharge

• 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.

  30 days post discharge

• Acceptance of music therapy intervention

  Favorable responses to qualitative interviews

  37 days post discharge

Secondary Outcomes (11)

• Change from baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function Short Form 4a

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

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

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

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

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

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

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

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

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

Study Arms (2)

Music Therapy

EXPERIMENTAL

Participants 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.

Behavioral: Music Therapy

Control

NO INTERVENTION

No 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.

Interventions

Music Therapy BEHAVIORAL

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.

Music Therapy

Eligibility Criteria

• Age: 30 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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
• \. Randomized to the control arm

Sponsors & Collaborators

• Samuel Rodgers-Melnick: lead
• Kulas Foundation: collaborator

Study Sites (1)

University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106, United States

Location

MeSH Terms

Conditions

Heart Failure; Pulmonary Disease, Chronic Obstructive

Interventions

Music Therapy

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Sensory Art Therapies; Complementary Therapies; Therapeutics; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Samuel Rodgers-Melnick, MPH, MT-BC

  University Hospitals Cleveland Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MPH, MT-BC

Model Details: 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.

Study Record Dates

• First Submitted: August 6, 2024
• First Posted: August 9, 2024
• Study Start: August 26, 2024
• Primary Completion: June 17, 2025
• Study Completion: June 17, 2025
• Last Updated: August 6, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)