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

Conduct a pilot study (n = 20) to explore the feasibility and acceptability of the MAJOR CHORD music therapy (MT) intervention (i.e., two in-person MT sessions prior to discharge and two virtual MT sessions post-discharge) and collection of patient-reported outcomes through 30 days after hospital discharge. The investigators will uncover any potential modifications that need to be made to the intervention and data collection process prior to initiating the randomized trial.

Study Overview

• Status: Completed
• Conditions: Heart Failure; Chronic Obstructive Pulmonary Disease
• Intervention / Treatment: Behavioral: Music Therapy

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44106
      • University Hospitals Cleveland Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age range: ≥40 to ≤89 years
• Hospitalized at UH Cleveland Medical Center (UHCMC) with anticipated length of stay following recruitment ≥ 2 days as documented in electronic health record (EHR)
• Diagnosed (i.e., ICD-10 code within the EHR) with either COPD (J44) or HF (I50) with confirmed ICD-10 code in EHR
• Able to read and understand English
• Screening positive for depression and/or anxiety as evidenced by: GAD-7 anxiety score ≥ 10 and PHQ-9 depression score ≥ 10
• Access to WiFi, active email address & laptop, tablet, and/or PC with videoconferencing capabilities
• Has reliable support person who can be available to respond in case of a medical emergency at any time
• Has reliable access to a mobile device with active data plan

Exclusion Criteria:

• Significant hearing and/or visual impairment as documented in EHR
• Unable to independently provide consent (i.e., no proxy consent)
• Active suicidal ideation documented in inpatient psychiatry note during current hospital admission or expressed at any point verbally or in writing to study staff
• Severe psychological comorbidity (e.g., psychosis, schizophrenia) that would prevent patient from engaging fully in intervention as documented in EHR
• Currently admitted to intensive care unit
• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Music Therapy; Participants will receive 2 in-person music therapy sessions during hospital admission and 2 virtual music therapy sessions post-discharge.

Behavioral: Music Therapy; Board-certified music therapists (i.e., MT-BC credential) will provide two music therapy sessions, a minimum of 24 hours apart, 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University Hospitals Cleveland Medical Center
• Collaborators: Kulas Foundation
• Investigators: Principal Investigator: Samuel Rodgers-Melnick, MPH, MT-BC, University Hospitals Cleveland Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2024
• Primary Completion (Actual): June 11, 2024
• Study Completion (Actual): June 11, 2024

Study Registration Dates

• First Submitted: January 9, 2024
• First Submitted That Met QC Criteria: January 9, 2024
• First Posted (Actual): January 19, 2024

Study Record Updates

• Last Update Posted (Actual): August 7, 2024
• Last Update Submitted That Met QC Criteria: August 6, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: Heart Failure; Chronic Obstructive Pulmonary Disease; Virtual; Music Therapy; In-person
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Respiratory Tract Diseases; Disease Attributes; Heart Failure; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Chronic Disease
• Other Study ID Numbers: STUDY20230897

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No