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

September 25, 2023 updated by: Dr Daphne Cheung, The Hong Kong Polytechnic University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Hong Kong
      • Hong Kong, Hong Kong
        • School of Nursing, the Hong Kong Polytechnic University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention
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
Subjects will listen their preferred music and move their body actively with music
Placebo Comparator: Wait-list control
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
Social activity acts as control with similar dose and intensity with intervention arm

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in patients' anxiety
Time Frame: 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)
Baseline, immediate post-intervention (month 3)
Changes in patients' depression
Time Frame: Baseline, immediate post-intervention (month 3)
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
Time Frame: Baseline, immediate post-intervention (month 3)
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
Time Frame: Baseline, immediate post-intervention (month 3)
Heart Rate Variability (HRV)
Baseline, immediate post-intervention (month 3)
Changes in caregivers' well-being
Time Frame: Baseline, immediate post-intervention (month 3)
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
Time Frame: 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
Baseline, immediate post-intervention (month 3)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in volunteers' satisfaction from volunteering
Time Frame: Baseline, 3-month post-intervention (month 6)
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
Time Frame: Baseline, 3-month post-intervention (month 6)
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
Time Frame: Baseline, 3-month post-intervention (month 6)
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
Time Frame: Baseline, 3-month post-intervention (month 6)
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)

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility of MWM intervention in community
Time Frame: 3-month post-intervention
Interview caregivers, patients, collaborating community centre staff and supporting volunteers
3-month post-intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Hong Kong Polytechnic University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 18, 2018

Primary Completion (Actual)

July 31, 2019

Study Completion (Actual)

July 31, 2019

Study Registration Dates

First Submitted

April 11, 2018

First Submitted That Met QC Criteria

June 20, 2018

First Posted (Actual)

July 2, 2018

Study Record Updates

Last Update Posted (Actual)

September 28, 2023

Last Update Submitted That Met QC Criteria

September 25, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 5-ZH2P

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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