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

Heart Failure Clinical Trial

— MAJOR CHORD  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06214325
• Other study ID #: STUDY20230897
• Status: Recruiting
• Phase: N/A
• Start date: January 15, 2024
• Est. completion date: June 30, 2024

Study information

• Verified date: January 2024
• Source: University Hospitals Cleveland Medical Center
• Contact: Tracy L Segall, MSHS
• Phone: 216-844-7925
• Email: Tracy.Segall[@]UHhospitals.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: June 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 89 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Disease
• Chronic Obstructive Pulmonary Disease
• Heart Failure
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

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.

Locations

Country	Name	City	State
United States	University Hospitals Cleveland Medical Center	Cleveland	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
University Hospitals Cleveland Medical Center	Kulas Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Acceptance of music therapy intervention	Favorable responses to qualitative interviews	37 days post discharge