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Completed

NCT Number: NCT06214325

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

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.

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Key information

Conditions

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

Age range

40 year–89 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Comparison of actual and anticipated recruitment rates

    Time frame: 30 days post discharge

    Actual rates of recruitment as compared to the anticipated recruitment rate of at least 35% of those approached for the study.

  2. Comparison of actual and anticipated retention rates

    Time frame: 30 days post discharge

    Actual rates of retention as compared to the anticipated retention rate of 70% of participants until the final survey time point.

  3. Comparison of actual and anticipated attendance rates

    Time frame: 30 days post discharge

    Actual rates of attendance rates as compared to the anticipated 3/4 sessions among at least 70% of participants in the music therapy arm.

  4. Comparison of actual and anticipated completion rates

    Time frame: 30 days post discharge

    Actual rates of completion rates as compared to the anticipated at least 70% of 15-day and 30-day follow-up measures.

  5. Number of participants report daily music exercise use

    Time frame: 30 days post discharge

    At least 60% of participants in the music therapy arm reporting use of music exercises at least once every other day.

  6. Acceptance of music therapy intervention

    Time frame: 37 days post discharge

    Favorable responses to qualitative interviews

Sponsors and collaborators

Lead sponsor

University Hospitals Cleveland Medical Center

Other

Collaborators

  • Kulas Foundation

Registry information

Acronym: MAJOR CHORD

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jan 19, 2024
Registry last updated
Aug 7, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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