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

NCT ID: NCT06214325

Last Updated: 2024-08-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-15
• Study Completion Date: 2024-06-11

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Music Therapy

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

Group Type: EXPERIMENTAL

Music Therapy

Intervention Type: 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.

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 89 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kulas Foundation

OTHER

Sponsor Role: collaborator

University Hospitals Cleveland Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Samuel Rodgers-Melnick

Integrative Health Research & Data Specialist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Samuel Rodgers-Melnick, MPH, MT-BC

Role: PRINCIPAL_INVESTIGATOR

University Hospitals Cleveland Medical Center

Locations

University Hospitals Cleveland Medical Center

Cleveland, Ohio, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 40229734 (View on PubMed)

Other Identifiers

STUDY20230897

Identifier Type: -

Identifier Source: org_study_id