Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06546319
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-06
Brief Title:
Music Therapy to Address Patients Journeys with Chronic Illness Outcomes and Readmission - MAJOR CHORD RCT
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Music Therapy to Address Patients Journeys with Chronic Illness Outcomes and Readmission MAJOR CHORD RCT a Randomized Controlled Trial
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 eg physical function depression anxiety fatigue and pain interference b perceived stress c self-efficacy and d 30-day readmission rates
Detailed Description:
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 ie 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 ie MT-BC credential will provide two music therapy sessions not to occur on the same day that include education and disease-specific content eg 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 eg breathing imagery harmonica exercise 4 time to process the participants 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 eg hip-hop gospel RB jazz rock andor 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 participants hospital room during in-person sessions or 2 a virtual music therapy studio at UH Cleveland Medical Center or the music therapists 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 participants voice may be recorded as part of the second virtual music therapy intervention ie 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 eg 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 participants family andor home care nursing team to facilitate the participants 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
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 ie MT-BC credential will provide two music therapy sessions not to occur on the same day that include education and disease-specific content eg 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 eg breathing imagery harmonica exercise 4 time to process the participants 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 eg hip-hop gospel RB jazz rock andor 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 participants hospital room during in-person sessions or 2 a virtual music therapy studio at UH Cleveland Medical Center or the music therapists 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 participants voice may be recorded as part of the second virtual music therapy intervention ie 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 eg 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 participants family andor home care nursing team to facilitate the participants 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None