Music-with-Movement Intervention for People With Early Dementia and Their Families
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 95
- 试验地点
- 1
- 主要终点
- Change of Rating anxiety in Dementia (RAID)
研究概览
简要总结
This study intends to use music and movement (MWM) to reduce anxiety and behavioral symptoms of people with early dementia (PWD) and their family carers in the community. It also aims to examine whether MWM can enhance the sleep quality of PWD and their family caregivers and promote their well-being.
This is a mixed methods study with the quantitative paradigm being the main research approached used. The quantitative arm will be a randomized controlled trial (RCT). The qualitative arm will adopt a naturalistic approach through interviewing for data collection. Recruited subjects from the community centres of non-government organizations (NGOs) will be randomly allocated to the intervention and control group.
The outcome measures of the PWD will include Rating Anxiety in Dementia (RAID), Geriatric Depression Scale (GDS), Neuropsychiatric Inventory Questionnaire (NPI-Q), Pittsburgh Sleep Quality Index (PQSI), Quality of Life - Alzheimer's Disease (QOL-AD), Mini-Mental State Examination (MMSE), Revised Life Event Scale (RLES), Modified Brathel Index (MBI) and Non-pharmacological Therapy Experience Scale (NPTES), whereas the outcome measures of the family caregivers will be Patient Health Questionnaire 9 (PHQ-9), Generalized Anxiety Disorder 7 (GAD-7), Zarit Burden Scale (ZBD), Pittsburgh Sleep Quality Index (PSQI), Reverse Life event Scale (RLES), and World Health Organization Quality of Life-BREF (WHOQOL-BREF).
To address the research questions, data will be collected at baseline (T0), immediately post-intervention at 8-weeks (T1), and 8 post-intervention (T2). The qualitative arm of this study will contribute to the understanding of issues and effects of MWM as an intervention. Its finding will complement the results obtained from the RCT.
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
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 65 or above
- •Community-dwelling
- •With early dementia [Clinical Dementia Rating (CDR) Scale scored between 0.5 to 1, denoting mild to early signs of cognitive impairment]
- •In a stable medical condition
- •Communicate in Cantonese
- •Has a family caregiver who is willing to participate in the study
- •Family caregiver of the recruited PWD
- •Is the primary caregiver of the PWD (defined as the one in the family who is responsible for taking care of the PWD regardless of whether s/he is living together with the PWD in the same dwelling place. That is to say, him/herself considers self as the person responsible to provide needed care for the PWD; or other family members would expect him/her to perform or be responsible for main caregiving tasks needed by the PWD.)
- •Is related to the PWD and not a paid live-in care attendant
- •Paid caregiver is allow to assist the primary caregivers if he/she attended the MWM training, but can contribute no more than 50% of the delivery of intervention.
- •Completed no less than 80% of the training program for delivery the MWM protocol
- •Has been involved in the delivery of the MWM intervention to the intervention group for at least one cycle of recruitment Note: staff recruitment as the informant of the qualitative arm of this study is also entirely voluntary.
排除标准
- •PWD With acute exacerbation of chronic illnesses that affects the adherence of the MWM protocol, e.g., acute heart failure, relapse of acute depressive disorder unable to hear even with the use of hearing aids unable to sit independently for around 45 minutes
- •Family caregivers of the recruited PWD
- •Staff - Nil
结局指标
主要结局
Change of Rating anxiety in Dementia (RAID)
时间窗: At baseline (T0), immediately post-intervention at 8-weeks (T1), and 8-weeks post-intervention (T2)
For PWD only Comparisons of changes of RAID will be considered as follows: 1. T1 - T0 2. T2 - T0 3. T2 - T1
次要结局
- Change of Geriatric Depression Scale (GDS)(At baseline (T0), immediately post-intervention at 8-weeks (T1), and 8-weeks post-intervention (T2))
- Change of Quality of Life - Alzheimer's Disease (QOL-AD)(At baseline (T0), immediately post-intervention at 8-weeks (T1), and 8-weeks post-intervention (T2))
- Change of Zarit Burden Scale (ZBS)(At baseline (T0), immediately post-intervention at 8-weeks (T1), and 8-weeks post-intervention (T2))
- Change of Mini-Mental State Examination (MMSE)(At baseline (T0), immediately post-intervention at 8-weeks (T1), and 8-weeks post-intervention (T2))
- Change of Lawton's Instrumental Activity of Daily Living (IADL)(At baseline (T0), immediately post-intervention at 8-weeks (T1), and 8-weeks post-intervention (T2))
- Change of Neuropsychiatric Inventory Questionnaire(NPI-Q)(At baseline (T0), immediately post-intervention at 8-weeks (T1), and 8-weeks post-intervention (T2))
- Change of Pittsburgh Sleep Quality Index (PQSI)(At baseline (T0), immediately post-intervention at 8-weeks (T1), and 8-weeks post-intervention (T2))
- Change of Patient Health Questionnaire 9 (PHQ-9)(At baseline (T0), immediately post-intervention at 8-weeks (T1), and 8-weeks post-intervention (T2))
- Change of Revised Life Event Scale (RLES)(At baseline (T0), immediately post-intervention at 8-weeks (T1), and 8-weeks post-intervention (T2))
- Change of World Health Organization Quality of Life-BREF (WHOQOL-BREF)(At baseline (T0), immediately post-intervention at 8-weeks (T1), and 8-weeks post-intervention (T2))
- Change of Generalized Anxiety Disorder 7(At baseline (T0), immediately post-intervention at 8-weeks (T1), and 8-weeks post-intervention (T2))
- Change of Modified Barthel Index (MBI)(At baseline (T0), immediately post-intervention at 8-weeks (T1), and 8-weeks post-intervention (T2))
研究者
Claudia K Y Lai
Professor
The Hong Kong Polytechnic University