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

NCT06214325 | Completed

• 1 other identifier: STUDY20230897
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure; Chronic Obstructive Pulmonary Disease

Keywords

Music Therapy; Chronic Obstructive Pulmonary Disease; Heart Failure; In-person; Virtual

Outcome Measures

Primary Outcomes (6)

• 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

Study Arms (1)

Music Therapy

EXPERIMENTAL

Participants will receive 2 in-person music therapy sessions during hospital admission and 2 virtual music therapy sessions post-discharge.

Behavioral: Music Therapy

Interventions

Music Therapy BEHAVIORAL

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.

Music Therapy

Eligibility Criteria

• Age: 40 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospitals Cleveland Medical Center: lead
• Kulas Foundation: collaborator

Study Sites (1)

University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106, United States

Location

Related Publications (1)

• Yu H, Foss A, Segall TL, Block S, Risser K, Razzak R, Zacharias M, Teba CV, Rodgers-Melnick SN. Refining a hybrid music therapy intervention for chronic obstructive pulmonary disease and heart failure: a single arm pilot study. BMC Complement Med Ther. 2025 Apr 14;25(1):139. doi: 10.1186/s12906-025-04887-x.

  PMID: 40229734 DERIVED

MeSH Terms

Conditions

Heart Failure; Pulmonary Disease, Chronic Obstructive

Interventions

Music Therapy

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Sensory Art Therapies; Complementary Therapies; Therapeutics; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Samuel Rodgers-Melnick, MPH, MT-BC

  University Hospitals Cleveland Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Integrative Health Research & Data Specialist

Study Record Dates

• First Submitted: January 9, 2024
• First Posted: January 19, 2024
• Study Start: January 15, 2024
• Primary Completion: June 11, 2024
• Study Completion: June 11, 2024
• Last Updated: August 7, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)