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临床试验/NCT03575026
NCT03575026已完成不适用

Partnership With the Community to Improve the Well-being of People With Mild Cognitive Impairment (MCI)/Early Dementia and Their Caregivers With Music Intervention: an Effectiveness-Implementation Cluster Randomized Clinical Hybrid Trial

The Hong Kong Polytechnic University1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2018年4月18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
100
试验地点
1
主要终点
Changes in patients' depression

研究概览

简要总结

This is a 12-week cluster randomized controlled trial utilizing music-with-movement (MWM) intervention compared with usual care to investigate the effect of MWM among subjects with early dementia or mild cognitive impairment implemented by their caregivers at home.

详细描述

Dementia is a neurodegenerative disorder and it can adversely affect patient's cognitive, behavioural, social and emotional functioning. Its prevalence will increase continuously because of the increase in aging population and it is predicted that around 333,000 people in Hong Kong (equivalent to 11% population aged 60 or above) will suffer from dementia in year 2039. The gradual functional decline, communication difficulties, the behavioural symptoms associated with cognitive impairment, may affect the relationships with the family members and the wellbeing. A latest Cochrane Review commented that music-based intervention may be helpful to improve emotional wellbeing and quality of life according to some limited evidences, as well as depressive symptoms, although future studies with larger sample sizes and more rigorous research design are suggested

In 2014 - 2016, our team has modified a music-with-movement intervention designed for nursing home residents with moderate dementia, into a protocol specified for caregiver-delivered home-based intervention to promote the psychosocial wellbeing of people with early dementia in Hong Kong. We found that the dyadic music-with-movement intervention yielded significant reduction on anxiety levels of people with early dementia as compared to control group. Similar, Särkämö and colleagues also found that caregiver-implemented music intervention group have reduced depression of people with early dementia and reduced caregiver burden. With the strong evidence that music intervention is useful in improving the wellbeing of people with early dementia and their family caregiver, it is essential to disseminate the culture-appropriated and validated intervention for promoting health and evaluate its effectiveness in real-practice setting by implementation research.

This research is anchored by a conceptual framework of leisure and subjective wellbeing. This framework explained that through participating in activities outside the obligated works (either paid or unpaid) that is subjectively regarded as leisure, would lead to an improvement of well-being through five psychological mechanisms, namely detachment-relaxation, autonomy, mastery, meaning and affiliation. Caregivers and care-recipients are found relaxed after participating in music intervention because they are temporary detached from the everyday caregiving chaos. Participating in an intervention designed by the participants themselves would increase their sense of autonomy and mastery. During the dyadic music intervention, the caregivers and people with MCI/early dementia would design their activities within the music-with-movement framework after instruction of music therapist that allow them to exercise their choices based on their music preference. Through the interaction in the dyadic intervention, it has been found that through participating in dyadic music intervention, people with dementia and their caregivers have improved in relationship and social inclusiveness. Caregivers would feel their competence or mastery in the skills when leading music intervention. Staff and caregivers reported that activities that address the psychological needs, provide enjoyment, value individuality, reinforce a sense of identity and belonging are meaningful to people with dementia. Therefore, we hypothesized that dyadic music-with-movement intervention would improve the subjective wellbeing of both the people with MCI/early dementia and their caregiver, if there are relevant implementation strategies to increase the ease of uptake of the intervention. For example, stress of caregivers could be relieved by successful music intervention.

When the aim is to maximize the uptake of the intervention in the real-life settings as a routine, we have to examine the influence of contextual factors on implementation. Hence, this study have three main objectives:

  1. To test the effectiveness of the dyadic music-with-movement intervention on wellbeing of people with MCI/early dementia, and of their caregivers in real-life settings;
  2. To conduct a process evaluation of the effectiveness-implementation study by gathering information on the implementation process; and
  3. To validate and extend the applicability of "Leisure & Wellbeing" conceptual framework to the dyads.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

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

入选标准

  • Aged 60 or above
  • Cognitively impaired, defined by Global Deterioration Scale 3 or 4
  • Community-dwelling
  • With stable medical condition
  • Able to communicate in Cantonese
  • have a family caregiver who was willing to take part in the study

排除标准

  • Suffering from any critical medical or psychiatric illnesses
  • Unable to hear even using hearing aids
  • Unable to sit independently for around 30 minutes
  • Received music intervention within 6 months
  • Participate in any clinical trial within 6 months prior to the start of study
  • Inclusion criteria:
  • Primary caregiver of the PWeD
  • Related to the PWeD and not a paid live-in care attendant
  • Exclusion criteria:
  • Suffering from any critical medical or psychiatric illnesses
  • Received music intervention within 6 months prior to the start of study

结局指标

主要结局

Changes in patients' depression

时间窗: Baseline, immediate post-intervention (month 3)

Cornell scale for depression in dementia (CSDD), total score (range 0-36), higher indicates higher depression

Changes in caregivers' stress and well-being

时间窗: Baseline, immediate post-intervention (month 3)

Perceived Stress Scale 10 (PSS-10), total score (range 0-40), higher indicates higher perceived stress

Changes in caregivers' well-being

时间窗: Baseline, immediate post-intervention (month 3)

Positive Aspects of Caregiving scale (PAC), total score (range 0-44), higher indicates more gain from caregiving experience

Changes in caregivers' relationship with PWD

时间窗: Baseline, immediate post-intervention (month 3)

Quality of the Caregiver-Care Recipient Relationship, 4 questions (range 0-4 each), higher score indicates better relationship between caregiver and care recipient

Changes in patients' anxiety

时间窗: Baseline, immediate post-intervention (month 3)

Rating Anxiety in Dementia (RAID), total score (range 0-54), higher indicates higher anxiety level (score\>=11 indicates clinically significant anxiety)

Changes in caregivers' stress

时间窗: Baseline, immediate post-intervention (month 3)

Heart Rate Variability (HRV)

次要结局

  • Changes in volunteers' satisfaction from volunteering(Baseline, 3-month post-intervention (month 6))
  • Changes in volunteers' attitude towards dementia(Baseline, 3-month post-intervention (month 6))
  • Changes in volunteers' knowledge towards dementia(Baseline, 3-month post-intervention (month 6))
  • Changes in volunteers' expectation from volunteering(Baseline, 3-month post-intervention (month 6))

研究者

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

Dr Daphne Cheung

Research Assistant Professor

The Hong Kong Polytechnic University

研究点 (1)

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