- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01976832
Music-with-Movement Intervention for People With Early Dementia and Their Families
This study intends to use music and movement (MWM) to reduce anxiety and behavioral symptoms of people with early dementia (PWD) and their family carers in the community. It also aims to examine whether MWM can enhance the sleep quality of PWD and their family caregivers and promote their well-being.
This is a mixed methods study with the quantitative paradigm being the main research approached used. The quantitative arm will be a randomized controlled trial (RCT). The qualitative arm will adopt a naturalistic approach through interviewing for data collection. Recruited subjects from the community centres of non-government organizations (NGOs) will be randomly allocated to the intervention and control group.
The outcome measures of the PWD will include Rating Anxiety in Dementia (RAID), Geriatric Depression Scale (GDS), Neuropsychiatric Inventory Questionnaire (NPI-Q), Pittsburgh Sleep Quality Index (PQSI), Quality of Life - Alzheimer's Disease (QOL-AD), Mini-Mental State Examination (MMSE), Revised Life Event Scale (RLES), Modified Brathel Index (MBI) and Non-pharmacological Therapy Experience Scale (NPTES), whereas the outcome measures of the family caregivers will be Patient Health Questionnaire 9 (PHQ-9), Generalized Anxiety Disorder 7 (GAD-7), Zarit Burden Scale (ZBD), Pittsburgh Sleep Quality Index (PSQI), Reverse Life event Scale (RLES), and World Health Organization Quality of Life-BREF (WHOQOL-BREF).
To address the research questions, data will be collected at baseline (T0), immediately post-intervention at 8-weeks (T1), and 8 post-intervention (T2). The qualitative arm of this study will contribute to the understanding of issues and effects of MWM as an intervention. Its finding will complement the results obtained from the RCT.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Hong Kong, Hong Kong
- The Hong Kong Polytechnic University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
PWD
- Aged 65 or above
- Community-dwelling
- With early dementia [Clinical Dementia Rating (CDR) Scale scored between 0.5 to 1, denoting mild to early signs of cognitive impairment]
- In a stable medical condition
- Communicate in Cantonese
- Has a family caregiver who is willing to participate in the study
Family caregiver of the recruited PWD
- Is the primary caregiver of the PWD (defined as the one in the family who is responsible for taking care of the PWD regardless of whether s/he is living together with the PWD in the same dwelling place. That is to say, him/herself considers self as the person responsible to provide needed care for the PWD; or other family members would expect him/her to perform or be responsible for main caregiving tasks needed by the PWD.)
- Is related to the PWD and not a paid live-in care attendant
- Paid caregiver is allow to assist the primary caregivers if he/she attended the MWM training, but can contribute no more than 50% of the delivery of intervention.
Staff
- Completed no less than 80% of the training program for delivery the MWM protocol
- Has been involved in the delivery of the MWM intervention to the intervention group for at least one cycle of recruitment Note: staff recruitment as the informant of the qualitative arm of this study is also entirely voluntary.
Exclusion Criteria:
- PWD With acute exacerbation of chronic illnesses that affects the adherence of the MWM protocol, e.g., acute heart failure, relapse of acute depressive disorder unable to hear even with the use of hearing aids unable to sit independently for around 45 minutes
Family caregivers of the recruited PWD
- Nil
- Staff - Nil
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Music with movement
Participants in the intervention group will receive the intervention delivered by their family member according to the validated 8-weeks music with movement (MWM) intervention protocol.
|
Participants in the intervention group will receive the intervention delivered by their family member according to the validated 8-week music with movement (MWM) intervention protocol.
|
Active Comparator: Social interaction
The control group will receive a protocol for social interaction as the control condition, where caregivers were asked to discuss up to date news with PWeD. The design of the control condition will be highly similar to the MWM protocol in terms of the frequency and duration of the sessions, the number of people involved, and the total intervention period. |
The control group will receive a protocol for social interaction as the control condition, where caregivers were asked to discuss up to date news with PWeD. The design of the control condition will be highly similar to the MWM protocol in terms of the frequency and duration of the sessions, the number of people involved, and the total intervention period. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change of Rating anxiety in Dementia (RAID)
Time Frame: At baseline (T0), immediately post-intervention at 8-weeks (T1), and 8-weeks post-intervention (T2)
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For PWD only Comparisons of changes of RAID will be considered as follows:
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At baseline (T0), immediately post-intervention at 8-weeks (T1), and 8-weeks post-intervention (T2)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change of Geriatric Depression Scale (GDS)
Time Frame: At baseline (T0), immediately post-intervention at 8-weeks (T1), and 8-weeks post-intervention (T2)
|
For PWD only Comparisons of changes of RAID will be considered as follows:
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At baseline (T0), immediately post-intervention at 8-weeks (T1), and 8-weeks post-intervention (T2)
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Change of Neuropsychiatric Inventory Questionnaire(NPI-Q)
Time Frame: At baseline (T0), immediately post-intervention at 8-weeks (T1), and 8-weeks post-intervention (T2)
|
For PWD only Comparisons of changes of RAID will be considered as follows:
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At baseline (T0), immediately post-intervention at 8-weeks (T1), and 8-weeks post-intervention (T2)
|
Change of Pittsburgh Sleep Quality Index (PQSI)
Time Frame: At baseline (T0), immediately post-intervention at 8-weeks (T1), and 8-weeks post-intervention (T2)
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For PWD and Caregivers of PWD only Comparisons of changes of RAID will be considered as follows:
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At baseline (T0), immediately post-intervention at 8-weeks (T1), and 8-weeks post-intervention (T2)
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Change of Quality of Life - Alzheimer's Disease (QOL-AD)
Time Frame: At baseline (T0), immediately post-intervention at 8-weeks (T1), and 8-weeks post-intervention (T2)
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For PWD only Comparisons of changes of RAID will be considered as follows:
|
At baseline (T0), immediately post-intervention at 8-weeks (T1), and 8-weeks post-intervention (T2)
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Change of Patient Health Questionnaire 9 (PHQ-9)
Time Frame: At baseline (T0), immediately post-intervention at 8-weeks (T1), and 8-weeks post-intervention (T2)
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For Caregivers of PWD only Comparisons of changes of RAID will be considered as follows:
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At baseline (T0), immediately post-intervention at 8-weeks (T1), and 8-weeks post-intervention (T2)
|
Change of Zarit Burden Scale (ZBS)
Time Frame: At baseline (T0), immediately post-intervention at 8-weeks (T1), and 8-weeks post-intervention (T2)
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For Caregivers of PWD only Comparisons of changes of RAID will be considered as follows:
|
At baseline (T0), immediately post-intervention at 8-weeks (T1), and 8-weeks post-intervention (T2)
|
Change of World Health Organization Quality of Life-BREF (WHOQOL-BREF)
Time Frame: At baseline (T0), immediately post-intervention at 8-weeks (T1), and 8-weeks post-intervention (T2)
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For Caregivers of PWD only Comparisons of changes of RAID will be considered as follows:
|
At baseline (T0), immediately post-intervention at 8-weeks (T1), and 8-weeks post-intervention (T2)
|
Change of Generalized Anxiety Disorder 7
Time Frame: At baseline (T0), immediately post-intervention at 8-weeks (T1), and 8-weeks post-intervention (T2)
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For Caregivers of PWD only Comparisons of changes of RAID will be considered as follows:
|
At baseline (T0), immediately post-intervention at 8-weeks (T1), and 8-weeks post-intervention (T2)
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Change of Mini-Mental State Examination (MMSE)
Time Frame: At baseline (T0), immediately post-intervention at 8-weeks (T1), and 8-weeks post-intervention (T2)
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For PWD only Comparisons of changes of RAID will be considered as follows:
|
At baseline (T0), immediately post-intervention at 8-weeks (T1), and 8-weeks post-intervention (T2)
|
Change of Revised Life Event Scale (RLES)
Time Frame: At baseline (T0), immediately post-intervention at 8-weeks (T1), and 8-weeks post-intervention (T2)
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For PWD and Caregivers of PWD Comparisons of changes of RAID will be considered as follows:
|
At baseline (T0), immediately post-intervention at 8-weeks (T1), and 8-weeks post-intervention (T2)
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Change of Lawton's Instrumental Activity of Daily Living (IADL)
Time Frame: At baseline (T0), immediately post-intervention at 8-weeks (T1), and 8-weeks post-intervention (T2)
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For PWD only Comparisons of changes of RAID will be considered as follows:
|
At baseline (T0), immediately post-intervention at 8-weeks (T1), and 8-weeks post-intervention (T2)
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Change of Modified Barthel Index (MBI)
Time Frame: At baseline (T0), immediately post-intervention at 8-weeks (T1), and 8-weeks post-intervention (T2)
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For PWD only Comparisons of changes of RAID will be considered as follows:
|
At baseline (T0), immediately post-intervention at 8-weeks (T1), and 8-weeks post-intervention (T2)
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change of Non-pharmacological Therapy Experience Scale (NPTES)
Time Frame: once per month within the intervention period
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NPTES will be collected within the intervention period on several occasions.
That is to say, to be obtained once per month between T0 to T1, and only for the intervention group.
It is an observational tool intended for capturing the qualitative information during an intervention.
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once per month within the intervention period
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Collaborators and Investigators
Investigators
- Principal Investigator: Kam Yuk, Claudia Lai, PhD, School of Nursing, The Hong Kong Polytechnic University
- Principal Investigator: Shuk Ching, Jacqueline Ho, PhD, School of Nursing, The Hong Kong Polytechnic University
- Principal Investigator: Sze Ki, Daphne Cheung, PhD, School of Nursing, The Hong Kong Polytechnic University
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 5-ZH96
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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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