University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106, United States
NCT Number: NCT06546319
Conduct a randomized trial (n = 60: with n = 30 receiving music therapy and n = 30 receiving usual care) to investigate the feasibility, acceptability, and preliminary efficacy of the MAJOR CHORD music therapy intervention compared to usual care on (a) health-related quality of life (e.g., physical function, depression, anxiety, fatigue, and pain interference), (b) perceived stress, (c) self-efficacy, and (d) 30-day readmission rates
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Notify Me30 year–89 year
All sexes
Interventional
Not applicable
Cleveland, Ohio, 44106, United States
For the intervention arm, in-person sessions will be conducted at the discretion of the music therapist and at a convenient time for the participant. Post-discharge music therapy sessions will be conducted virtually via secure telehealth platform (i.e., Zoom for Healthcare) with participants at home, skilled nursing facility, or in the hospital, if readmitted, while the music therapist is stationed at UHCMC or another UH facility in a private location. Reminder phone calls and MyCap messages will be completed one day prior to the scheduled virtual session. Links to the virtual session will be sent at the time of scheduling and again just prior to the session.
For both arms, follow-up measures will be completed using REDCap surveys sent via Twilio text message at 15- and 30-days following the hospital discharge date. REDCap will be used to collect the PROMIS - 29, Perceived Stress Scale - 4 (PSS-4), PROMIS General Self-Efficacy 4a, PROMIS Instrumental Support 4a, and PROMIS Emotional Support 4a scores at (1) Baseline, (2) 15-days post discharge, and (3) 30-days post discharge, with REDCap ensuring these are delivered on the nearest weekday rather than a weekend. Reminder texts will be sent out at day 16 & 17 and day 31 & 32 for those who do not complete their follow-up assessments following the initial prompt.
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. Each music therapy session will include (1) setting an agenda; (2) an explanation of the music exercise; (3) a demonstration of the music exercise in which the MT-BC will engage the participant in practicing the music exercise (e.g., breathing, imagery, harmonica exercise); (4) time to process the participant's response to the exercise; (5) time for the MT-BC to electronically deliver the music exercise to the participant and ensure that the participant has all materials necessary to use the exercise at home; and (6) a homework assignment for the participant to practice the music exercise taught in that session at least once per day until the following MT session. The genres of each music exercise will be personalized to participants' preferences (e.g., hip-hop, gospel, R&B, jazz, rock, and/or soul). Each music exercise will last an average of 12 minutes. As the music exercises are being demonstrated, the MT-BC will simultaneously record the exercise as it is being delivered live. These recordings will be created in a high-quality recording studio, using either (1) a mobile unit in the participant's hospital room during in-person sessions or (2) a virtual music therapy studio at UH Cleveland Medical Center or the music therapist's private office at another UH facility during virtual sessions while participants are at home or in a care facility. The participant will hear the music live and receive a recording at the end of each session for their homework assignment. Each participant's voice may be recorded as part of the second virtual music therapy intervention (i.e., fourth of four sessions) which features a personalized songwriting intervention to which the patient can choose to contribute their voice. These recordings will be uploaded to a personalized UH Enterprise Box folder created for each participant. In-person MT sessions will be audio-recorded, and virtual sessions will be audio and video recorded through UH Zoom for Healthcare for quality assurance and fidelity checking. Recordings will be uploaded to a password-protected secure server and removed from recording devices. MT sessions will be reviewed for quality assurance for the first 5 participants and every 5th participant thereafter.
At the request of the participant, study staff may meet with the participant either in-person prior to discharge or virtually post-discharge to assist the participant in accessing Zoom and practicing the skills needed for videoconferencing (e.g., joining audio, muting, unmuting).
Participants will receive text message links every 7 days following the first music therapy session to log their home exercise activity.
The study staff will coordinate with the participant, participant's family and/or home care nursing team to facilitate the participant's engagement in virtual visits following discharge and before the first virtual music therapy session. The music therapist will provide instructions for virtual access and resources. The study staff will follow up with the participant following discharge to assist them with engaging in virtual music therapy post-discharge.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Randomized Control Trial
Inclusion criteria
Qualitative Interview Inclusion Criteria 1. Agreed to be contacted for the qualitative interview during contenting process for the RCT
Exclusion criteria
Qualitative Interview Exclusion Criteria
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.
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.
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.
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.
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.
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.
Time frame: 37 days post discharge
Favorable responses to qualitative interviews
Time frame: Pre-test at baseline, 15 days post-discharge, and 30 days post-discharge
Physical function (4 questions)
Time frame: Pre-test at baseline, 15 days post-discharge, and 30 days post-discharge
Anxiety (4 questions)
Time frame: Pre-test at baseline, 15 days post-discharge, and 30 days post-discharge
Depression (4 questions)
Time frame: Pre-test at baseline, 15 days post-discharge, and 30 days post-discharge
Fatigue (4 questions)
Time frame: Pre-test at baseline, 15 days post-discharge, and 30 days post-discharge
Sleep disturbance (4 questions)
Time frame: Pre-test at baseline, 15 days post-discharge, and 30 days post-discharge
Ability to participate in social roles and activities (4 questions)
Time frame: Pre-test at baseline, 15 days post-discharge, and 30 days post-discharge
Pain interference (4 questions)
Time frame: Pre-test at baseline, 15 days post-discharge, and 30 days post-discharge
General self-efficacy (4 questions)
Time frame: Pre-test at baseline, 15 days post-discharge, and 30 days post-discharge
Emotional support (4 questions)
Time frame: Pre-test at baseline, 15 days post-discharge, and 30 days post-discharge
Instrumental support (4 questions)
Time frame: Pre-test at baseline, 15 days post-discharge, and 30 days post-discharge
Perceived stress (4 questions)
Samuel Rodgers-Melnick
Other
Music Therapy to Address Patients' Journeys With Chronic Illness, Outcomes, and Readmission (MAJOR CHORD RCT): A Randomized Controlled Trial
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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