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临床试验/NCT06546319
NCT06546319已完成不适用

Music Therapy to Address Patients' Journeys With Chronic Illness, Outcomes, and Readmission (MAJOR CHORD RCT): A Randomized Controlled Trial

Samuel Rodgers-Melnick2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年8月26日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
60
试验地点
2
主要终点
Number of participants report daily music exercise use

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

年龄范围
30 Years 至 89 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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)
  • Able to read and understand English
  • Hospitalized at UH Cleveland Medical Center (UHCMC) with anticipated length of stay following recruitment ≥ 2 days as documented in electronic health record (EHR) and confirmed by the clinical care team
  • Access to Wi-Fi, active email address, & laptop, tablet, smartphone, and/or PC with videoconferencing capabilities at home or the facility in which they will be discharged
  • Has reliable access to a mobile device with an active data plan at the hospital and at home and is comfortable accessing the internet and their email with this device
  • Qualitative Interview Inclusion Criteria
  • Agreed to be contacted for the qualitative interview during contenting process for the RCT

排除标准

  • Active confirmed or suspected COVID-19, or under droplet, contact, MRSA, and/or C.diff precaution notification as documented in the EHR
  • Included on the Music Therapy Referral patient list in the EHR
  • Significant hearing and/or visual impairment as documented in EHR
  • Unable to independently provide consent (i.e., no proxy consent)
  • Active suicidal ideation as documented in EHR during current hospital admission
  • Severe psychological comorbidity (e.g., psychosis, schizophrenia) that would prevent patient from engaging fully in intervention as documented in EHR
  • 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
  • Has end stage renal disease or is currently receiving dialysis
  • Qualitative Interview Exclusion Criteria
  • Randomized to the control arm

结局指标

主要结局

Number of participants report daily music exercise use

时间窗: 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.

Comparison of actual and anticipated recruitment rates

时间窗: 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

时间窗: 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

时间窗: 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.

Acceptance of music therapy intervention

时间窗: 37 days post discharge

Favorable responses to qualitative interviews

Comparison of actual and anticipated completion rates

时间窗: 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.

次要结局

  • Change from baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) Ability to Participate in Social Roles and Activities - Short Form 4a(Pre-test at baseline, 15 days post-discharge, and 30 days post-discharge)
  • Change from baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety Short Form 4a(Pre-test at baseline, 15 days post-discharge, and 30 days post-discharge)
  • Change from baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) Instrumental Support - Short Form 4a(Pre-test at baseline, 15 days post-discharge, and 30 days post-discharge)
  • Change from baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) Depression - Short Form 4a(Pre-test at baseline, 15 days post-discharge, and 30 days post-discharge)
  • Change from baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance - Short Form 4a(Pre-test at baseline, 15 days post-discharge, and 30 days post-discharge)
  • Change from baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function Short Form 4a(Pre-test at baseline, 15 days post-discharge, and 30 days post-discharge)
  • Change from baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue - Short Form 4a(Pre-test at baseline, 15 days post-discharge, and 30 days post-discharge)
  • Change from baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference - Short Form 4a(Pre-test at baseline, 15 days post-discharge, and 30 days post-discharge)
  • Change from baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) General Self Efficacy - Short Form 4a(Pre-test at baseline, 15 days post-discharge, and 30 days post-discharge)
  • Change from baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) Emotional Support - Short Form 4a(Pre-test at baseline, 15 days post-discharge, and 30 days post-discharge)
  • Change from baseline in Perceived Stress Scale - 4(Pre-test at baseline, 15 days post-discharge, and 30 days post-discharge)

研究者

发起方
Samuel Rodgers-Melnick
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Samuel Rodgers-Melnick

MPH, MT-BC

University Hospitals Cleveland Medical Center

研究点 (2)

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