Music Therapy to Address Patients' Journeys With Chronic Illness, Outcomes, and Readmission - MAJOR CHORD RCT
NCT Number: NCT06546319
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Heart Failure|Chronic Obstructive Pulmonary Disease
Interventions: BEHAVIORAL: Music Therapy
Sponsor: Samuel Rodgers-Melnick
Collaborators: Kulas Foundation
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 60
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: OTHER
Start Date: 2024-08-23
Completion Date: 2025-07
Locations: University Hospitals Cleveland Medical Center, Cleveland, Ohio, 44106, United States

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

Primary Outcome Measures: 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 Outcome Measures: Change from baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function Short Form 4a, Physical function (4 questions), 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, Anxiety (4 questions), 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, Depression (4 questions), 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, Fatigue (4 questions), 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, Sleep disturbance (4 questions), Pre-test at baseline, 15 days post-discharge, and 30 days post-discharge|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), Pre-test at baseline, 15 days post-discharge, and 30 days post-discharge|Change from baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference - Short Form 4a, Pain interference (4 questions), Pre-test at baseline, 15 days post-discharge, and 30 days post-discharge|Change from baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) General Self Efficacy - Short Form 4a, General self-efficacy (4 questions), Pre-test at baseline, 15 days post-discharge, and 30 days post-discharge|Change from baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) Emotional Support - Short Form 4a, Emotional support (4 questions), Pre-test at baseline, 15 days post-discharge, and 30 days post-discharge|Change from baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) Instrumental Support - Short Form 4a, Instrumental support (4 questions), Pre-test at baseline, 15 days post-discharge, and 30 days post-discharge|Change from baseline in Perceived Stress Scale - 4, Perceived stress (4 questions), Pre-test at baseline, 15 days post-discharge, and 30 days post-discharge