Music Therapy to Address Patients' Journeys With Chronic Illness, Outcomes, and Readmission

Not Applicable

Completed

• Conditions: Heart Failure; Chronic Obstructive Pulmonary Disease
• Interventions: Behavioral: Music Therapy

• Registration Number: NCT06214325
• Lead Sponsor: University Hospitals Cleveland Medical Center

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-01-09
• Study First Submitted QC: 2024-01-09
• Study Start: 2024-01-15
• Study First Posted: 2024-01-19
• Primary Completion: 2024-06-11
• Study Completion: 2024-06-11
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-06
• Last Update Posted: 2024-08-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Music Therapy	Music Therapy	Participants will receive 2 in-person music therapy sessions during hospital admission and 2 virtual music therapy sessions post-discharge.

Primary Outcome Measures

Name	Time	Method
Number of participants report daily music exercise use	30 days post discharge	At least 60% of participants in the music therapy arm reporting use of music exercises at least once every other day.
Acceptance of music therapy intervention	37 days post discharge	Favorable responses to qualitative interviews
Comparison of actual and anticipated recruitment rates	30 days post discharge	Actual rates of recruitment as compared to the anticipated recruitment rate of at least 35% of those approached for the study.
Comparison of actual and anticipated retention rates	30 days post discharge	Actual rates of retention as compared to the anticipated retention rate of 70% of participants until the final survey time point.
Comparison of actual and anticipated completion rates	30 days post discharge	Actual rates of completion rates as compared to the anticipated at least 70% of 15-day and 30-day follow-up measures.
Comparison of actual and anticipated attendance rates	30 days post discharge	Actual rates of attendance rates as compared to the anticipated 3/4 sessions among at least 70% of participants in the music therapy arm.

Trial Locations

Locations (1)

University Hospitals Cleveland Medical Center; 🇺🇸 Cleveland, Ohio, United States