A Stand-alone Therapeutic Music-with-Movement Programme for People With Cognitive Impairment

October 19, 2023 updated by: Dr Daphne Cheung, The Hong Kong Polytechnic University

The number of people living with cognitive impairment is increasing at an exponential rate. More than 100,000 older people are living with dementia in Hong Kong. Alarmingly, about 60% of long-term care residents or day-care centre users are living with dementia, nearly all of whom experience anxiety, depression, or other behavioural and psychological symptoms that place heavy demands on healthcare support and jeopardize their quality of life.

A standalone Music-with-Movement system is developed by integrating innovative and communication technology to facilitate the delivery of an evidence-based music-with-movement intervention. The technology employed are music library, 6-axis motion-sensing music instruments, wireless charging, and RFID.

This study aims to evaluate the changes in health outcomes (cognition, psychosocial well-being and perceived support) of older adults after receiving the service delivered by the trained staff using the standalone music-with-movement system.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Methods:

  1. Aims and objectives:

    1. to evaluate the feasibility of the system supporting staff from elderly care institutes in leading musical activities (i.e., recruitment, retention, and acceptability);
    2. to evaluate the engagement of the participants in the intervention; and
    3. to preliminarily examine the health conditions of older adults with cognitive impairment.

  2. Methods:

    1. Design: Single-group pre-and-post-test design
    2. Participants: Older adults with cognitive impairment.
    3. Setting: Elderly care institutes, such as daycare centres, community centres, and/or nursing homes.
    4. Sample size: 750 participants.
    5. Outcomes: Recruitment rate, attrition rate, acceptability, any adverse events, engagement in the intervention, health outcomes (social support, frailty, health-related QoL, MoCA).
    6. Data analysis strategies:
    7. Ethical consideration: Approval has been obtained from the University (HSEARS20211026009)

Study Type

Interventional

Enrollment (Estimated)

750

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
        • Recruiting
        • School of Nursing, The Hong Kong Polytechnic University
        • Contact:

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Older adults with cognitive impairment
  • In a stable medical condition

Exclusion Criteria:

  • With critical medical or psychiatric problems
  • Those with uncorrectable hearing impairment

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: Health Services Research
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment group
Music-with-movement intervention supported by the stand-alone music-with-movement system.
Behavioral: Music-with-movement
The intervention group participants will receive 12 weekly music-with-movement interventions facilitated by trained staff in a community centre or a residential care home. The duration lasts 30 minutes to one hour. It can be carried out individually or with up to six persons in a group. The intervention will be supported by the standalone music-with-movement system.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recruitment Rate
Time Frame: through study completion, an average of 3 year

Recruitment rate-defined as the proportion of eligible participants (following screening) who agreed to take part in the study (calculated as number of participants recruited (numerator)/number of eligible participants (denominator)).

Reference: Easpaig, B. N. G., Zhai, J., Gray, R., Brown, E., & Bressington, D. (2022). Recruitment, attrition and intervention completion in clinical trials of psychosocial interventions involving people with early and emerging psychosis: a systematic review protocol. BMJ open, 12(9), e060863.
through study completion, an average of 3 year
Attribution Rate
Time Frame: through study completion, an average of 3 year

Attrition rate -defined as the proportion of participants at defined study points who discontinued the intervention or were lost to follow-up (calculated as number of participants that withdraw (numerator)/number of participants randomised (denominator)).

Attrition rates will be calculated as three points: after randomisation, during the intervention and at final follow-up.

Reference:

Easpaig, B. N. G., Zhai, J., Gray, R., Brown, E., & Bressington, D. (2022). Recruitment, attrition and intervention completion in clinical trials of psychosocial interventions involving people with early and emerging psychosis: a systematic review protocol. BMJ open, 12(9), e060863.
through study completion, an average of 3 year
Intervention completion rate
Time Frame: through study completion, an average of 3 year
Intervention completion rate - defined as the proportion of participants who completed the allocated intervention (for at least 70% attendance). Calculated as number of participants allocated to the intervention that completed the minimum attendance (numerator)/number of participants allocated to treatment (denominator).
through study completion, an average of 3 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Multidimensional Scale of Perceived Social Support (MSPSS) Score
Time Frame: 6 months
The Multidimensional Scale of Perceived Social Support ("MSPSS") is a 12-item instrument designed to measure an individual's perception of support from 3 sources: family, friends and a significant other (4 items for each subscale) (Zimet et al., 1988), rated on a 7-point Likert scale ranging from "1" Very Strongly Disagree to "7" Very Strongly Agree.
6 months
Change in Frail Scale
Time Frame: 6 months
The scale is a short five-question assessment that can screen for frailty (Fatigue, Resistance, Ambulation, Illnesses, & Loss of Weight) (Abellan van Kan et al., 2008) . Scores range from 0-5 (i.e., 1 point for each component; 0=best to 5=worst) and represent frail (3-5), pre-frail (1-2), and robust (0) health status.
6 months
Change in Montreal Cognitive Assessment 5-minute (MoCA)
Time Frame: 6 months
The 5-minute "Mini MoCA" is an abbreviated version of MoCA, composed of the tasks proven most sensitive to mild cognitive impairment. The MoCA 5-min protocol in Cantonese version was validated to be reliable cognitive screening tools (Wong et al., 2015).
6 months
Change in Health-related Quality of Life (EQ-5D-3L)
Time Frame: 6 months
The EQ-5D-3L descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression (EuroQol Group). Each dimension has 3 levels: no problems, some problems, and extreme problems. The total score of five items can describe the patient's health state. Also, the participants are asked to self-rating their health state on a vertical visual analogue scale (0 = the worst health state to 100 = the best health state) to reflect their own judgement.
6 months
Change in Neuropsychiatric Symptoms - Informant-based
Time Frame: 6 months
This is an informant-based instrument that measures the presence and severity of 12 neuropsychiatric symptoms in older adults with cognitive impairment and their associated distress over the previous month (Kaufer et al., 2000).
6 months
Engagement during the intervention
Time Frame: 3 months
Trained research assistant will observe the participants' engagement level during the intervention measured with Non-pharmacological Therapy Experience Scale (overall score ranges 0 - 30). Higher score means better engagement.
3 months

Collaborators and Investigators

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

Sponsor

The Hong Kong Polytechnic University

Investigators

  • Principal Investigator: Daphne Sze Ki Cheung, PhD, The Hong Kong Polytechnic University

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)

June 1, 2022

Primary Completion (Estimated)

April 30, 2024

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

September 27, 2023

First Submitted That Met QC Criteria

October 19, 2023

First Posted (Actual)

October 25, 2023

Study Record Updates

Last Update Posted (Actual)

October 25, 2023

Last Update Submitted That Met QC Criteria

October 19, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HSEARS20211026009

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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