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Behavioral Intervention

Music Therapy for Chronic Disease

N/A

Recruiting

Led By Samuel Rodgers-Melnick, MPH, MT-BC

Research Sponsored by Samuel Rodgers-Melnick

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age range: ≥30 to ≤89 years

Primary indication for current hospitalization is either COPD or HF with confirmed ICD-10 code in the electronic health record (EHR)

Must not have

Active confirmed or suspected COVID-19, or under droplet, contact, MRSA, and/or C.diff precaution notification as documented in the EHR

Unable to independently provide consent (i.e., no proxy consent)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up pre-test at baseline, 15 days post-discharge, and 30 days post-discharge

Awards & highlights

No Placebo-Only Group

Summary

This trial is looking at whether a specific music therapy intervention called MAJOR CHORD can help improve the quality of life, reduce stress, increase self-confidence, and lower hospital readmission rates for patients compared

Who is the study for?

This trial is for patients with chronic illnesses like heart failure or COPD. Participants should be adults who are currently hospitalized and have a history of these conditions. They must be able to give consent and participate in music therapy sessions.

What is being tested?

The MAJOR CHORD study tests if music therapy can improve life quality, reduce stress, boost confidence in managing health (self-efficacy), and lower the chance of being readmitted to the hospital within 30 days compared to usual care.

What are the potential side effects?

Music therapy is generally considered safe with minimal risk of side effects. However, some individuals may experience emotional discomfort or distress during sessions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 30 and 89 years old.

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I am hospitalized primarily for COPD or heart failure, as confirmed in my medical records.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am currently diagnosed with or suspected to have COVID-19.

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I can give my own consent without needing a proxy.

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My condition is end-stage heart failure or severe COPD.

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I am currently receiving hospice care.

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I have severe kidney disease or am on dialysis.

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I am currently undergoing treatment for cancer.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ pre-test at baseline, 15 days post-discharge, and 30 days post-discharge

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~pre-test at baseline, 15 days post-discharge, and 30 days post-discharge

This trial's timeline: 3 weeks for screening, Varies for treatment, and pre-test at baseline, 15 days post-discharge, and 30 days post-discharge for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Acceptance of music therapy intervention

Comparison of actual and anticipated attendance rates

Comparison of actual and anticipated completion rates

+3 more

Secondary study objectives

Change from baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) Ability to Participate in Social Roles and Activities - Short Form 4a

Change from baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety Short Form 4a

Change from baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) Depression - Short Form 4a

+8 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Music TherapyExperimental Treatment1 Intervention

Participants will complete a series of questionnaires after enrolling, 15 days post hospital discharge, and 30 days post hospital discharge. Board-certified music therapists (i.e., MT-BC credential) will provide two music therapy sessions, not to occur on the same day, 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.

Group II: ControlActive Control1 Intervention

No additional intervention will be conducted for this arm during their study participation. Participants will complete a series of questionnaires after enrolling, 15 days post hospital discharge, and 30 days post hospital discharge. Participants randomized to the control arm will be offered a single virtual music therapy session after 30 days post-discharge. No data will be collected during this music therapy session.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Music Therapy

2019

Completed Phase 3

~1660

0 / 8Eligibility criteria met