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

NCT ID: NCT06546319

Last Updated: 2025-08-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-08-26
• Study Completion Date: 2025-06-17

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

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.

Conditions

Heart Failure; Chronic Obstructive Pulmonary Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Music Therapy

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.

Group Type: EXPERIMENTAL

Music Therapy

Intervention Type: 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.

Control

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Music Therapy

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

1. Age range: ≥30 to ≤89 years

2. Primary indication for current hospitalization is either COPD or HF with confirmed ICD-10 code in the electronic health record (EHR)

3. Able to read and understand English

4. 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

5. 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

6. 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

Exclusion Criteria

1. Active confirmed or suspected COVID-19, or under droplet, contact, MRSA, and/or C.diff precaution notification as documented in the EHR

2. Included on the Music Therapy Referral patient list in the EHR

3. Significant hearing and/or visual impairment as documented in EHR

4. Unable to independently provide consent (i.e., no proxy consent)

5. Active suicidal ideation as documented in EHR during current hospital admission

6. Severe psychological comorbidity (e.g., psychosis, schizophrenia) that would prevent patient from engaging fully in intervention as documented in EHR

7. Receiving active cancer treatment (e.g., chemotherapy, radiation, immunotherapy) as documented in EHR

8. Diagnosed with medical condition likely to be terminal within 24 weeks as documented in EHR

9. On wait list for heart transplantation or ventricular assist device (VAD) as documented in EHR

10. NYHA Stage IV HF or end-stage COPD as documented in EHR

11. Receiving hospice care as documented in EHR

12. Active substance abuse as documented in EHR

13. Has end stage renal disease or is currently receiving dialysis

1. Randomized to the control arm

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 89 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kulas Foundation

OTHER

Sponsor Role: collaborator

Samuel Rodgers-Melnick

OTHER

Sponsor Role: lead

Responsible Party

Samuel Rodgers-Melnick

MPH, MT-BC

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Samuel Rodgers-Melnick, MPH, MT-BC

Role: PRINCIPAL_INVESTIGATOR

University Hospitals Cleveland Medical Center

Locations

University Hospitals Cleveland Medical Center

Cleveland, Ohio, United States

Countries

United States

Other Identifiers

STUDY20240686

Identifier Type: -

Identifier Source: org_study_id