Clinical trial NCT06546319: Music Therapy to Address Patients' Journeys with Chronic Illness, Outcomes, and Readmission - MAJOR CHORD RCT
Official title: Music Therapy to Address Patients' Journeys with Chronic Illness, Outcomes, and Readmission (MAJOR CHORD RCT): a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Heart Failure
Chronic Obstructive Pulmonary Disease
Keywords: Music Therapy
Chronic Obstructive Pulmonary Disease
Heart Failure
In-person
Virtual
Lead sponsor: University Hospitals Cleveland Medical Center
Sponsor class: OTHER
Collaborators: name: Kulas Foundation
First posted: 2024-08-09
Enrollment: 60
Sex: ALL
Minimum age (years): 30
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: OTHER

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.

Eligibility criteria: Randomized Control Trial

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, \&amp;amp; 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

Qualitative Interview Inclusion Criteria 1. Agreed to be contacted for the qualitative interview during contenting process for the RCT

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

Qualitative Interview Exclusion Criteria

1. Randomized to the control arm

Primary outcomes:
measure: Comparison of actual and anticipated recruitment rates
timeFrame: 30 days post discharge
measure: Comparison of actual and anticipated retention rates
timeFrame: 30 days post discharge
measure: Comparison of actual and anticipated attendance rates
timeFrame: 30 days post discharge
measure: Comparison of actual and anticipated completion rates
timeFrame: 30 days post discharge
measure: Number of participants report daily music exercise use
timeFrame: 30 days post discharge
measure: Acceptance of music therapy intervention
timeFrame: 37 days post discharge
Secondary outcomes:
measure: Change from baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function Short Form 4a
timeFrame: Pre-test at baseline, 15 days post-discharge, and 30 days post-discharge
measure: Change from baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety Short Form 4a
timeFrame: Pre-test at baseline, 15 days post-discharge, and 30 days post-discharge
measure: Change from baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) Depression - Short Form 4a
timeFrame: Pre-test at baseline, 15 days post-discharge, and 30 days post-discharge
measure: Change from baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue - Short Form 4a
timeFrame: Pre-test at baseline, 15 days post-discharge, and 30 days post-discharge
measure: Change from baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance - Short Form 4a
timeFrame: Pre-test at baseline, 15 days post-discharge, and 30 days post-discharge
measure: Change from baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) Ability to Participate in Social Roles and Activities - Short Form 4a
timeFrame: Pre-test at baseline, 15 days post-discharge, and 30 days post-discharge
measure: Change from baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference - Short Form 4a
timeFrame: Pre-test at baseline, 15 days post-discharge, and 30 days post-discharge
measure: Change from baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) General Self Efficacy - Short Form 4a
timeFrame: Pre-test at baseline, 15 days post-discharge, and 30 days post-discharge
measure: Change from baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) Emotional Support - Short Form 4a
timeFrame: Pre-test at baseline, 15 days post-discharge, and 30 days post-discharge
measure: Change from baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) Instrumental Support - Short Form 4a
timeFrame: Pre-test at baseline, 15 days post-discharge, and 30 days post-discharge
measure: Change from baseline in Perceived Stress Scale - 4
timeFrame: Pre-test at baseline, 15 days post-discharge, and 30 days post-discharge
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: University Hospitals Cleveland Medical Center
state: Ohio
Study officials:
affiliation: University Hospitals Cleveland Medical Center
name: Samuel Rodgers-Melnick, MPH, MT-BC
role: PRINCIPAL_INVESTIGATOR
References: