Heart FailureMAJOR CHORDNCT06214325
Music Therapy to Address Patients' Journeys With Chronic Illness, Outcomes, and Readmission
A study testing Music Therapy in people with Heart Failure and Chronic Obstructive Pulmonary Disease, run by University Hospitals Cleveland Medical Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 40 to 89 years
- Conditions the study is for
- Heart Failure, Chronic Obstructive Pulmonary Disease
- What is being tested?
- Music Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jan 2024to 11 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
About this study
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.
- Being tested
- Music Therapy
- Keywords
- Music Therapy, Chronic Obstructive Pulmonary Disease, Heart Failure, In-person, Virtual
- Medical subject headings
- Heart Failure, Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Music TherapyBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Music Therapy | Experimental | Participants will receive 2 in-person music therapy sessions during hospital admission and 2 virtual music therapy sessions post-discharge. Receives: Behavioral: Music Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 30 days post discharge
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.
Measured: 30 days post discharge
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.
Measured: 30 days post discharge
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.
Measured: 30 days post discharge
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.
Measured: 30 days post discharge
Acceptance of music therapy intervention
Favorable responses to qualitative interviews
Measured: 37 days post discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2024
- Study start15 Jan 2024
- Primary completion11 Jun 2024
- Study completion11 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by University Hospitals Cleveland Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospitals Cleveland Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Kulas Foundation
- Responsible party
- Principal investigator, Samuel Rodgers-Melnick, University Hospitals Cleveland Medical Center
- Investigators
- Samuel Rodgers-Melnick, MPH, MT-BC, Principal investigator, University Hospitals Cleveland Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06214325
- Sponsor's protocol ID
- STUDY20230897
- Acronym
- MAJOR CHORD
- Status last verified
- Aug 2024
- First submitted
- 9 Jan 2024
- Last updated
- 7 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40229734
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Music Therapy to Address Patients' Journeys With Chronic Illness, Outcomes, and Readmission
- ClinicalTrials.gov ID
- NCT06214325
- Acronym / sponsor ID
- MAJOR CHORD / STUDY20230897
- Keywords
- Music Therapy, Chronic Obstructive Pulmonary Disease, Heart Failure, In-person, Virtual
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University Hospitals Cleveland Medical CenterUniversity, hospital or other
- Collaborators
- Kulas Foundation
- Study start
- 15 Jan 2024 (actual)
- Primary completion
- 11 Jun 2024 (actual)
- Study completion
- 11 Jun 2024 (actual)
- First posted
- 19 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Music Therapy | Experimental | Behavioral: Music TherapyParticipants will receive 2 in-person music therapy sessions during hospital admission and 2 virtual music therapy sessions post-discharge. |
Who may qualify
- Ages
- 40 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Music TherapyBoard-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. | Behavioural | Music Therapy |
Primary outcome
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.
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.
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.
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.
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.
Acceptance of music therapy intervention
Time frame: 37 days post discharge
Favorable responses to qualitative interviews
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2024.
- Derived from this study: PubMed 40229734Yu 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.
- Individual participant dataSharing planned: No
Related trials for Heart Failure
RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF)
Heart Failure With Reduced Ejection Fraction, Iron Deficiency
Not yet recruitingPhase 2
A Study of Bimagrumab in Participants With HFpEF
Heart Failure, Diastolic, Diastolic Heart Failure
Recruiting
Evaluation of a French Hospital Discharge Therapeutic Education Program by Nurses for Heart Failure Patient (EduSor)
Heart Failure
Active, not recruiting
Assessment of Combined CCM and ICD Device in HFrEF
Heart Failure, Heart Failure With Reduced Ejection Fraction
Not yet recruiting
RELIEVE-HFrEF TRIAL: REducing Lung congestIon Symptoms Using the v-wavE Shunt in adVancEd Heart Failure With Reduced EF
Heart Failure and Reduced Ejection Fraction, Heart Failure Chronic
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Samuel Rodgers-Melnick, MPH, MT-BC principal investigator
University Hospitals Cleveland Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Music Therapy in people with Heart Failure and Chronic Obstructive Pulmonary Disease, run by University Hospitals Cleveland Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of actual and anticipated recruitment rates (time frame: 30 days post discharge). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06214325, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2024.