Effectiveness-Implementation Cluster RCT to Improve Community-dwelling Early Dementia Patients by Music Intervention

Study Overview
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Brief Summary
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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.

Detailed Description
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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: 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; To conduct a process evaluation of the effectiveness-implementation study by gathering information on the implementation process; and To validate and extend the applicability of Leisure & Wellbeing conceptual framework to the dyads. In this project, one of the implementation strategies to maximize the uptake of the music intervention by the dyads, is to train a team volunteers to support the caregivers and people with MCI/early dementia, which is a unique group of population. There is a general lack of knowledge and inappropriate attitude towards dementia or Alzheimer's disease worldwide. In Hong Kong, it was reported that university students majoring in medicine, nursing, occupational therapy and social work showed inadequate knowledge towards this group of patients. By providing training for volunteers to support participating dyads, it would be able to provide a better understanding on dementia and create a supportive community for dementia. Therefore, we will explore the changes in the following outcomes of the volunteers: To examine the change of knowledge and attitudes towards dementia of the volunteers before and after participating in the project; and To examine the change of satisfaction and motivation to volunteering before and after participating in the project.

Official Title
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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

Conditions
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Dementia

Intervention / Treatment
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* Behavioral: Music-with-movement
* Behavioral: Usual care


Participation Criteria
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Eligibility Criteria
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Patients with dementia/people with mild cognitive impairment Inclusion Criteria: 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 Exclusion Criteria: 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 Caregivers 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

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Subjects will receive 12-week music-with-movement intervention at home by their trained caregivers for 12 weeks, at least 3 sessions per week and 30 minutes for each session. | Behavioral: Music-with-movement<br>* Subjects will listen their preferred music and move their body actively with music<br>|
| Placebo Comparator: Wait-list control<br>Subjects will receive 12-week usual care (social activity) at home. Dose is similar to intervention arm. After the completion of 12-week usual care, subjects will receive the same music intervention as intervention arm. | Behavioral: Usual care<br>* Social activity acts as control with similar dose and intensity with intervention arm<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in patients' anxiety | Rating Anxiety in Dementia (RAID), total score (range 0-54), higher indicates higher anxiety level (score>=11 indicates clinically significant anxiety) | Baseline, immediate post-intervention (month 3) | 
| Changes in patients' depression | Cornell scale for depression in dementia (CSDD), total score (range 0-36), higher indicates higher depression | Baseline, immediate post-intervention (month 3) | 
| Changes in caregivers' stress and well-being | Perceived Stress Scale 10 (PSS-10), total score (range 0-40), higher indicates higher perceived stress | Baseline, immediate post-intervention (month 3) | 
| Changes in caregivers' stress | Heart Rate Variability (HRV) | Baseline, immediate post-intervention (month 3) | 
| Changes in caregivers' well-being | Positive Aspects of Caregiving scale (PAC), total score (range 0-44), higher indicates more gain from caregiving experience | Baseline, immediate post-intervention (month 3) | 
| Changes in caregivers' relationship with PWD | Quality of the Caregiver-Care Recipient Relationship, 4 questions (range 0-4 each), higher score indicates better relationship between caregiver and care recipient | Baseline, immediate post-intervention (month 3) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in volunteers' satisfaction from volunteering | Volunteer Satisfaction Index (VSI), 3 sub-scores (Relationship within organization [range 0-70], Personal gain [range 0-70], Relationship with peers [range 0-28]). In any sub-score, higher mean better satisfaction in that aspect | Baseline, 3-month post-intervention (month 6) | 
| Changes in volunteers' expectation from volunteering | Volunteer Functions Inventory (VFI), 6 sub-scores (Protective [range 0-35], Values [range 0-35], Career [range 0-35], Social [range 0-35], Understanding [range 0-35], Enhancement [range 0-35]). In each sub-score, higher score indicates that aspect motivates more that individual to be a volunteer. | Baseline, 3-month post-intervention (month 6) | 
| Changes in volunteers' knowledge towards dementia | Alzheimer's Disease Knowledge Scale (ADKS), total score (range 0-24), higher indicates better knowledge towards Alzheimer's Disease | Baseline, 3-month post-intervention (month 6) | 
| Changes in volunteers' attitude towards dementia | Dementia Attitude Scale (DAS), total score [calculated by summation of 2 sub-scores, range 0-140] and 2 sub-scores (Comfort [range 0-70], Knowledge [range 0-70]). Higher indicates more positive attitude towards people with dementia. | Baseline, 3-month post-intervention (month 6) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Early dementia, Caregiver, Anxiety, Well-being