Clinical trial NCT06100536: 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
Overall status: RECRUITING
Phase: NA
Conditions: Cognitive Impairment
Keywords: Music-with-Movement
Music
Intervention
Cognitive Impairment
Dementia
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
First posted: 2023-10-25
Enrollment: 750
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

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:

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)

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

Primary outcomes:
measure: Recruitment Rate
timeFrame: through study completion, an average of 3 year
measure: Attribution Rate
timeFrame: through study completion, an average of 3 year
measure: Intervention completion rate
timeFrame: through study completion, an average of 3 year
Secondary outcomes:
measure: Change in Multidimensional Scale of Perceived Social Support (MSPSS) Score
timeFrame: 6 months
measure: Change in Frail Scale
timeFrame: 6 months
measure: Change in Montreal Cognitive Assessment 5-minute (MoCA)
timeFrame: 6 months
measure: Change in Health-related Quality of Life (EQ-5D-3L)
timeFrame: 6 months
measure: Change in Neuropsychiatric Symptoms - Informant-based
timeFrame: 6 months
measure: Engagement during the intervention
timeFrame: 3 months
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: School of Nursing, The Hong Kong Polytechnic University
Study officials:
affiliation: The Hong Kong Polytechnic University
name: Daphne Sze Ki Cheung, PhD
role: PRINCIPAL_INVESTIGATOR
References: