search
Back to results

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

Primary Purpose

Cognitive Impairment

Status
Recruiting
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Music-with-movement
Sponsored by
The Hong Kong Polytechnic University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Cognitive Impairment focused on measuring Music-with-Movement, Music, Intervention, Cognitive Impairment, Dementia

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • School of Nursing, The Hong Kong Polytechnic UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment group

Arm Description

Music-with-movement intervention supported by the stand-alone music-with-movement system.

Outcomes

Primary Outcome Measures

Recruitment Rate
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.
Attribution Rate
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.
Intervention completion rate
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).

Secondary Outcome Measures

Change in Multidimensional Scale of Perceived Social Support (MSPSS) Score
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.
Change in Frail Scale
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.
Change in Montreal Cognitive Assessment 5-minute (MoCA)
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).
Change in Health-related Quality of Life (EQ-5D-3L)
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.
Change in Neuropsychiatric Symptoms - Informant-based
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).
Engagement during the intervention
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.

Full Information

First Posted
September 27, 2023
Last Updated
October 19, 2023
Sponsor
The Hong Kong Polytechnic University
search

1. Study Identification

Unique Protocol Identification Number
NCT06100536
Brief Title
A Stand-alone Therapeutic Music-with-Movement Programme for People With Cognitive Impairment
Official Title
A Stand-alone Therapeutic Music-with-Movement Programme for People With Cognitive Impairment
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2022 (Actual)
Primary Completion Date
April 30, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Hong Kong Polytechnic University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
Detailed Description
Methods: Aims and objectives: to evaluate the feasibility of the system supporting staff from elderly care institutes in leading musical activities (i.e., recruitment, retention, and acceptability); to evaluate the engagement of the participants in the intervention; and to preliminarily examine the health conditions of older adults with cognitive impairment. Methods: Design: Single-group pre-and-post-test design Participants: Older adults with cognitive impairment. Setting: Elderly care institutes, such as daycare centres, community centres, and/or nursing homes. Sample size: 750 participants. Outcomes: Recruitment rate, attrition rate, acceptability, any adverse events, engagement in the intervention, health outcomes (social support, frailty, health-related QoL, MoCA). Data analysis strategies: Ethical consideration: Approval has been obtained from the University (HSEARS20211026009)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cognitive Impairment
Keywords
Music-with-Movement, Music, Intervention, Cognitive Impairment, Dementia

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
750 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment group
Arm Type
Experimental
Arm Description
Music-with-movement intervention supported by the stand-alone music-with-movement system.
Intervention Type
Behavioral
Intervention Name(s)
Music-with-movement
Intervention Description
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.
Primary Outcome Measure Information:
Title
Recruitment Rate
Description
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.
Time Frame
through study completion, an average of 3 year
Title
Attribution Rate
Description
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.
Time Frame
through study completion, an average of 3 year
Title
Intervention completion rate
Description
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).
Time Frame
through study completion, an average of 3 year
Secondary Outcome Measure Information:
Title
Change in Multidimensional Scale of Perceived Social Support (MSPSS) Score
Description
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.
Time Frame
6 months
Title
Change in Frail Scale
Description
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.
Time Frame
6 months
Title
Change in Montreal Cognitive Assessment 5-minute (MoCA)
Description
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).
Time Frame
6 months
Title
Change in Health-related Quality of Life (EQ-5D-3L)
Description
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.
Time Frame
6 months
Title
Change in Neuropsychiatric Symptoms - Informant-based
Description
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).
Time Frame
6 months
Title
Engagement during the intervention
Description
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.
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Daphne Sze Ki Cheung, PhD
Phone
27664534
Email
daphne.cheung@polyu.edu.hk
First Name & Middle Initial & Last Name or Official Title & Degree
Daphne Sze Ki Cheung, PhD
Phone
27664534
Email
daphne.s.k.cheung@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daphne Sze Ki Cheung, PhD
Organizational Affiliation
The Hong Kong Polytechnic University
Official's Role
Principal Investigator
Facility Information:
Facility Name
School of Nursing, The Hong Kong Polytechnic University
City
Hong Kong
Country
Hong Kong
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daphne Cheung, PhD
Phone
+852 27664534
Email
daphne.cheung@polyu.edu.hk

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

We'll reach out to this number within 24 hrs