The Feasibility of a Dyadic Music-Based Intervention for Persons Living With Dementia and Their Care Partners
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Percentage of dyads who complete at least 4 out of 6 music/control condition sessions
研究概览
简要总结
This study examines the feasibility, acceptability, and preliminary outcomes of a structured music-based intervention for individuals living with dementia and their family caregivers.
详细描述
The dyadic MBI (adjusted in consultation with the Community Advisory Board) consists of training and support components centered on shared music listening. The interventionist will meet with the dyad once a week (frequency) for 45 minutes (dose) for 6 weeks (duration) to guide them through the weekly listening activity and provide support between sessions by email (per the dyad's preference). Dyads will be trained in 3 basic skills: 1) identifying personally-meaningful music, 2) approaching a mutual discussion of this music, and 3) engaging in shared music listening. Each session will follow a similar format.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inclusion for patient:
- •Age 60 and older
- •Existing physician diagnosis of dementia or self-reported memory impairment and Telephone Montreal Cognitive Assessment (T-MoCA) score between 18-25 with a capacity to consent. We chose the T-MoCA because it is ideal for subjects with visual impairment in a remote setting. Shown to be detection at remote detection of cognitive impairment.
- •Care partner or PLWD reporting current or past (8-12 months) dissatisfaction with the relationship score (score of 3 or less on the relationship satisfaction measure) given a dissatisfaction for one member of the dyad will affect the other person.
- •Stable dose of psychotropic medications, sedatives/hypnotics, anti-dementia or opioids in the past 60 days prior to enrollment to minimize the confounding effects of medications.
- •Exclusion for patient:
- •Hearing impairment (defined as inability to hear a normal speaking voice at distance of 1-1/2 feet) to exclude those who cannot hear the music intervention.
- •Planned transition to a residental or institutional care setting in less than 3 months (to decrease attrition).
- •Currently enrolled in an interventional clinical trial for PLWD aimed to improve relationship quality (to not confound the results)
- •Receiving hospice services.
- •Inclusion for care partner:
- •Must reside with the patient.
- •At least 21 years of age.
- •Self-identify as the primary care partner
- •Able to speak and read English
- •If on psychotropic medications at the time of telephone screen must be on a stable dose of the medication for 60 days prior to enrollment.
- •Consider themselves a family member (blood or non-blood relative)
- •Exclusion for care partner:
- •Do not reside with patient
- •Under the age of 21 years of age
- •Is not primary care partner
- •Not able to speak and read English
- •Has not been on a stable dose of psychotropic medications prior 60 to enrollment.
排除标准
- 未提供
研究组 & 干预措施
Persons Living With Dementia (PLWD) - Caregiver Dyads
The interventionist will meet with the PLWD and their care partner via Zoom to identify and build a playlist of the PLWD's preferred music on a mobile device. The interventionist will use Gerdner's Assessment of Personal Music 55 to learn about preferred genres, music artists, and types of music, and also review the PLWD's CDs, vinyl records, cassettes, and other music media to identify music.
干预措施: Dyadic Music-based Intervention (MBI) (Behavioral)
Reminiscence activity
干预措施: Reminiscence Activity (Behavioral)
结局指标
主要结局
Percentage of dyads who complete at least 4 out of 6 music/control condition sessions
时间窗: Up to the end of treatment, 6 weeks
Percentage of dyads who rate the music/control condition sessions after intervention as highly acceptable/satisfactory (the average score is greater than 3)
时间窗: Up to the end of treatment, 6 weeks
Researchers will evaluate the acceptability of each condition using the Acceptability of Intervention Measure (AIM). The AIM has 4 statements on a 5-point Likert scale, on which responses range from 1=completely disagree to 5=completely agree.
次要结局
- Reasons for dyad drop out(Up to the end of treatment, 6 weeks)
- Number of dyads screened per month(Before enrollment, monthly)
- Number of dyads enrolled per month(Before enrollment, monthly)
- Percentage of eligible dyads who enroll(At enrollment)
- Percentage of dyads who enroll and agree to be randomized(At enrollment)
- Percentage of dyads who complete baseline and follow-up measures(Up to the end of treatment, 6 weeks)
- Percentage of sessions delivered according to the protocol(Up to the end of treatment, 6 weeks)
- Percentage of measures that are completed at baseline and post intervention(Up to the end of treatment, 6 weeks)