Clinical trial NCT06214325: Music Therapy to Address Patients' Journeys With Chronic Illness, Outcomes, and Readmission
Official title: Music Therapy to Address Patients' Journeys With Chronic Illness, Outcomes, and Readmission
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Chronic Obstructive Pulmonary Disease
Keywords: Music Therapy
Chronic Obstructive Pulmonary Disease
Heart Failure
In-person
Virtual
Lead sponsor: University Hospitals Cleveland Medical Center
Sponsor class: OTHER
Collaborators: name: Kulas Foundation
First posted: 2024-01-19
Enrollment: 20
Sex: ALL
Minimum age (years): 40
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.


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

Primary outcomes:
measure: Comparison of actual and anticipated recruitment rates
timeFrame: 30 days post discharge
measure: Comparison of actual and anticipated retention rates
timeFrame: 30 days post discharge
measure: Comparison of actual and anticipated attendance rates
timeFrame: 30 days post discharge
measure: Comparison of actual and anticipated completion rates
timeFrame: 30 days post discharge
measure: Number of participants report daily music exercise use
timeFrame: 30 days post discharge
measure: Acceptance of music therapy intervention
timeFrame: 37 days post discharge
Secondary outcomes:
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: University Hospitals Cleveland Medical Center
state: Ohio
Study officials:
affiliation: University Hospitals Cleveland Medical Center
name: Samuel Rodgers-Melnick, MPH, MT-BC
role: PRINCIPAL_INVESTIGATOR
References: