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临床试验/NCT06214325
NCT06214325已完成不适用

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

University Hospitals Cleveland Medical Center2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2024年1月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
20
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 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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

入排标准

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

入选标准

  • 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

排除标准

  • 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

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.

Acceptance of music therapy intervention

时间窗: 37 days post discharge

Favorable responses to qualitative interviews

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 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.

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.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Samuel Rodgers-Melnick

Integrative Health Research & Data Specialist

University Hospitals Cleveland Medical Center

研究点 (2)

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