Cognitive ImpairmentNCT06100536
A Stand-alone Therapeutic Music-with-Movement Programme for People With Cognitive Impairment
A study testing Music-with-movement in people with Cognitive Impairment, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
Trial 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… Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Cognitive Impairment
- What is being tested?
- Music-with-movement
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 750 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Jun 2022to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Older adults with cognitive impairment
- In a stable medical condition
Who cannot join
- With critical medical or psychiatric problems
- Those with uncorrectable hearing impairment
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site, 1 recruiting
- Recruiting
School of Nursing, The Hong Kong Polytechnic University
Hong Kong
Daphne Cheung, PhD, +852 27664534, daphne.cheung@polyu.edu.hk
About this study
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.
Read the 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)
- Conditions
- Cognitive Impairment
- Being tested
- Music-with-movement
- Keywords
- Music-with-Movement, Music, Intervention, Cognitive Impairment, Dementia
- Medical subject headings
- Cognitive Dysfunction, Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Music-with-movementBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Experimental | Music-with-movement intervention supported by the stand-alone music-with-movement system. Receives: Behavioral: Music-with-movement |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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).
Measured: through study completion, an average of 3 year
Secondary outcomes (6)
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.
Measured: 6 months
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.
Measured: 6 months
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).
Measured: 6 months
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.
Measured: 6 months
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).
Measured: 6 months
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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2023
- Study start1 Jun 2022
- Primary completion30 Apr 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive ImpairmentStudies of the same condition, open and under way.
- More trials run by The Hong Kong Polytechnic UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 750 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Daphne Cheung, The Hong Kong Polytechnic University
- Investigators
- Daphne Sze Ki Cheung, PhD, Principal investigator, The Hong Kong Polytechnic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06100536
- Sponsor's protocol ID
- HSEARS20211026009
- Status last verified
- Oct 2023
- First submitted
- 27 Sep 2023
- Last updated
- 25 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Stand-alone Therapeutic Music-with-Movement Programme for People With Cognitive Impairment
- ClinicalTrials.gov ID
- NCT06100536
- Acronym / sponsor ID
- HSEARS20211026009
- Conditions
- Cognitive Impairment
- Keywords
- Music-with-Movement, Music, Intervention, Cognitive Impairment, Dementia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 750 participants (estimated)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 30 Apr 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 25 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Experimental | Behavioral: Music-with-movementMusic-with-movement intervention supported by the stand-alone music-with-movement system. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Older adults with cognitive impairment
- In a stable medical condition
Key exclusion criteria (2 listed)
- With critical medical or psychiatric problems
- Those with uncorrectable hearing impairment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Music-with-movementThe 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. | Behavioural | Treatment group |
Primary outcome
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.
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.
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).
6 secondary outcomes
Change in Multidimensional Scale of Perceived Social Support (MSPSS) Score
Time frame: 6 months
Change in Frail Scale
Time frame: 6 months
Change in Montreal Cognitive Assessment 5-minute (MoCA)
Time frame: 6 months
Change in Health-related Quality of Life (EQ-5D-3L)
Time frame: 6 months
Change in Neuropsychiatric Symptoms - Informant-based
Time frame: 6 months
Engagement during the intervention
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2023.
- Individual participant dataSharing planned: Undecided
Related trials for Cognitive Impairment
Recruiting
Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
Recruiting
HEARS-NPS: Addressing Hearing Loss as a Common Unmet Contributor of Neuropsychiatric Symptoms
Alzheimer Disease, Dementia
RecruitingObservational study
Locus Coeruleus and CCHS (Congenital Central Hypoventilation Syndrome)
Ondine Syndrome (Congenital Central Hypoventilation Syndrome)
RecruitingPhase 1
PET Imaging of Phosphodiesterase-4 (PDE4) in Volunteers With Alzheimer Disease (AD) or Mild Cognitive Impairment (MCI)
Alzheimer s Disease, Mild Cognitive Impairment
RecruitingObservational study
Community-based Screening for Alzheimer's Disease
Alzheimer's Disease(AD), Mild Cognitive Impairment (MCI)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daphne Sze Ki Cheung, PhD principal investigator
The Hong Kong Polytechnic University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Music-with-movement in people with Cognitive Impairment, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Daphne Sze Ki Cheung, PhD (27664534, daphne.cheung@polyu.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment Rate (time frame: through study completion, an average of 3 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Oct 2023.