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

Dementia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03575026
• Other study ID #: 5-ZH2P
• Status: Completed
• Phase: N/A
• Start date: April 18, 2018
• Est. completion date: July 31, 2019

Study information

• Verified date: September 2023
• Source: The Hong Kong Polytechnic University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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. 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: 4. To examine the change of knowledge and attitudes towards dementia of the volunteers before and after participating in the project; and 5. To examine the change of satisfaction and motivation to volunteering before and after participating in the project.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: July 31, 2019
• Est. primary completion date: July 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dementia

Intervention

Behavioral:
• Music-with-movement
Subjects will listen their preferred music and move their body actively with music
• Usual care
Social activity acts as control with similar dose and intensity with intervention arm

Locations

Country	Name	City	State
Hong Kong	School of Nursing, The Hong Kong Polytechnic University	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
The Hong Kong Polytechnic University

Country where clinical trial is conducted

Hong Kong, 

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* Note: There are 45 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Feasibility of MWM intervention in community	Interview caregivers, patients, collaborating community centre staff and supporting volunteers	3-month post-intervention
Primary	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)
Primary	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)
Primary	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)
Primary	Changes in caregivers' stress	Heart Rate Variability (HRV)	Baseline, immediate post-intervention (month 3)
Primary	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)
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)