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

NCT06100536 | Unknown DMC

• 1 other identifier: HSEARS20211026009
• Study Type: interventional
• Target: 750
• Locations: 1 country
• Sites: 1

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.

Conditions

Cognitive Impairment

Keywords

Music-with-Movement; Music; Intervention; Cognitive Impairment; Dementia

Outcome Measures

Primary Outcomes (3)

• 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.

  through study completion, an average of 3 year

• 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.

  through study completion, an average of 3 year

• 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).

  through study completion, an average of 3 year

Secondary Outcomes (6)

• Change in Multidimensional Scale of Perceived Social Support (MSPSS) Score

  6 months

• Change in Frail Scale

  6 months

• Change in Montreal Cognitive Assessment 5-minute (MoCA)

  6 months

• Change in Health-related Quality of Life (EQ-5D-3L)

  6 months

• Change in Neuropsychiatric Symptoms - Informant-based

  6 months

Study Arms (1)

Treatment group

EXPERIMENTAL

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

Behavioral: Music-with-movement

Interventions

Music-with-movement BEHAVIORAL

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.

Treatment group

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• The Hong Kong Polytechnic University: lead

Study Sites (1)

School of Nursing, The Hong Kong Polytechnic University

Hong Kong, Hong Kong

RECRUITING

MeSH Terms

Conditions

Cognitive Dysfunction; Dementia

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Daphne Sze Ki Cheung, PhD

  The Hong Kong Polytechnic University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Daphne Sze Ki Cheung, PhD

CONTACT

27664534; daphne.cheung@polyu.edu.hk

Daphne Sze Ki Cheung, PhD

CONTACT

27664534; daphne.s.k.cheung@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: September 27, 2023
• First Posted: October 25, 2023
• Study Start: June 1, 2022
• Primary Completion: April 30, 2024
• Study Completion: December 31, 2024
• Last Updated: October 25, 2023

Record last verified: 2023-10

Locations

HK (1)