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Music-with-Movement Intervention for People With Early Dementia and Their Families

Primary Purpose

Dementia, Anxiety, Sleep

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

About this trial

This is an interventional treatment trial for Dementia

Eligibility Criteria

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

Inclusion Criteria:

  1. 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
  2. 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.
  3. 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:

  1. 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
  2. Family caregivers of the recruited PWD

    - Nil

  3. Staff - Nil

Sites / Locations

  • The Hong Kong Polytechnic University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Music with movement

Social interaction

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Change of Rating anxiety in Dementia (RAID)
For PWD only Comparisons of changes of RAID will be considered as follows: T1 - T0 T2 - T0 T2 - T1

Secondary Outcome Measures

Change of Geriatric Depression Scale (GDS)
For PWD only Comparisons of changes of RAID will be considered as follows: T1 - T0 T2 - T0 T2 - T1
Change of Neuropsychiatric Inventory Questionnaire(NPI-Q)
For PWD only Comparisons of changes of RAID will be considered as follows: T1 - T0 T2 - T0 T2 - T1
Change of Pittsburgh Sleep Quality Index (PQSI)
For PWD and Caregivers of PWD only Comparisons of changes of RAID will be considered as follows: T1 - T0 T2 - T0 T2 - T1
Change of Quality of Life - Alzheimer's Disease (QOL-AD)
For PWD only Comparisons of changes of RAID will be considered as follows: T1 - T0 T2 - T0 T2 - T1
Change of Patient Health Questionnaire 9 (PHQ-9)
For Caregivers of PWD only Comparisons of changes of RAID will be considered as follows: T1 - T0 T2 - T0 T2 - T1
Change of Zarit Burden Scale (ZBS)
For Caregivers of PWD only Comparisons of changes of RAID will be considered as follows: T1 - T0 T2 - T0 T2 - T1
Change of World Health Organization Quality of Life-BREF (WHOQOL-BREF)
For Caregivers of PWD only Comparisons of changes of RAID will be considered as follows: T1 - T0 T2 - T0 T2 - T1
Change of Generalized Anxiety Disorder 7
For Caregivers of PWD only Comparisons of changes of RAID will be considered as follows: T1 - T0 T2 - T0 T2 - T1
Change of Mini-Mental State Examination (MMSE)
For PWD only Comparisons of changes of RAID will be considered as follows: T1 - T0 T2 - T0 T2 - T1
Change of Revised Life Event Scale (RLES)
For PWD and Caregivers of PWD Comparisons of changes of RAID will be considered as follows: T1 - T0 T2 - T0 T2 - T1
Change of Lawton's Instrumental Activity of Daily Living (IADL)
For PWD only Comparisons of changes of RAID will be considered as follows: T1 - T0 T2 - T0 T2 - T1
Change of Modified Barthel Index (MBI)
For PWD only Comparisons of changes of RAID will be considered as follows: T1 - T0 T2 - T0 T2 - T1

Full Information

First Posted
October 23, 2013
Last Updated
September 1, 2016
Sponsor
The Hong Kong Polytechnic University
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1. Study Identification

Unique Protocol Identification Number
NCT01976832
Brief Title
Music-with-Movement Intervention for People With Early Dementia and Their Families
Official Title
Music-with-Movement Intervention for People With Early Dementia and Their Families
Study Type
Interventional

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
July 2014 (undefined)
Primary Completion Date
May 2016 (Actual)
Study Completion Date
August 2016 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dementia, Anxiety, Sleep, Depression, Quality of Life

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
95 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Music with movement
Arm Type
Experimental
Arm Description
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.
Arm Title
Social interaction
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Music with movement
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Social interaction
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change of Rating anxiety in Dementia (RAID)
Description
For PWD only Comparisons of changes of RAID will be considered as follows: T1 - T0 T2 - T0 T2 - T1
Time Frame
At baseline (T0), immediately post-intervention at 8-weeks (T1), and 8-weeks post-intervention (T2)
Secondary Outcome Measure Information:
Title
Change of Geriatric Depression Scale (GDS)
Description
For PWD only Comparisons of changes of RAID will be considered as follows: T1 - T0 T2 - T0 T2 - T1
Time Frame
At baseline (T0), immediately post-intervention at 8-weeks (T1), and 8-weeks post-intervention (T2)
Title
Change of Neuropsychiatric Inventory Questionnaire(NPI-Q)
Description
For PWD only Comparisons of changes of RAID will be considered as follows: T1 - T0 T2 - T0 T2 - T1
Time Frame
At baseline (T0), immediately post-intervention at 8-weeks (T1), and 8-weeks post-intervention (T2)
Title
Change of Pittsburgh Sleep Quality Index (PQSI)
Description
For PWD and Caregivers of PWD only Comparisons of changes of RAID will be considered as follows: T1 - T0 T2 - T0 T2 - T1
Time Frame
At baseline (T0), immediately post-intervention at 8-weeks (T1), and 8-weeks post-intervention (T2)
Title
Change of Quality of Life - Alzheimer's Disease (QOL-AD)
Description
For PWD only Comparisons of changes of RAID will be considered as follows: T1 - T0 T2 - T0 T2 - T1
Time Frame
At baseline (T0), immediately post-intervention at 8-weeks (T1), and 8-weeks post-intervention (T2)
Title
Change of Patient Health Questionnaire 9 (PHQ-9)
Description
For Caregivers of PWD only Comparisons of changes of RAID will be considered as follows: T1 - T0 T2 - T0 T2 - T1
Time Frame
At baseline (T0), immediately post-intervention at 8-weeks (T1), and 8-weeks post-intervention (T2)
Title
Change of Zarit Burden Scale (ZBS)
Description
For Caregivers of PWD only Comparisons of changes of RAID will be considered as follows: T1 - T0 T2 - T0 T2 - T1
Time Frame
At baseline (T0), immediately post-intervention at 8-weeks (T1), and 8-weeks post-intervention (T2)
Title
Change of World Health Organization Quality of Life-BREF (WHOQOL-BREF)
Description
For Caregivers of PWD only Comparisons of changes of RAID will be considered as follows: T1 - T0 T2 - T0 T2 - T1
Time Frame
At baseline (T0), immediately post-intervention at 8-weeks (T1), and 8-weeks post-intervention (T2)
Title
Change of Generalized Anxiety Disorder 7
Description
For Caregivers of PWD only Comparisons of changes of RAID will be considered as follows: T1 - T0 T2 - T0 T2 - T1
Time Frame
At baseline (T0), immediately post-intervention at 8-weeks (T1), and 8-weeks post-intervention (T2)
Title
Change of Mini-Mental State Examination (MMSE)
Description
For PWD only Comparisons of changes of RAID will be considered as follows: T1 - T0 T2 - T0 T2 - T1
Time Frame
At baseline (T0), immediately post-intervention at 8-weeks (T1), and 8-weeks post-intervention (T2)
Title
Change of Revised Life Event Scale (RLES)
Description
For PWD and Caregivers of PWD Comparisons of changes of RAID will be considered as follows: T1 - T0 T2 - T0 T2 - T1
Time Frame
At baseline (T0), immediately post-intervention at 8-weeks (T1), and 8-weeks post-intervention (T2)
Title
Change of Lawton's Instrumental Activity of Daily Living (IADL)
Description
For PWD only Comparisons of changes of RAID will be considered as follows: T1 - T0 T2 - T0 T2 - T1
Time Frame
At baseline (T0), immediately post-intervention at 8-weeks (T1), and 8-weeks post-intervention (T2)
Title
Change of Modified Barthel Index (MBI)
Description
For PWD only Comparisons of changes of RAID will be considered as follows: T1 - T0 T2 - T0 T2 - T1
Time Frame
At baseline (T0), immediately post-intervention at 8-weeks (T1), and 8-weeks post-intervention (T2)
Other Pre-specified Outcome Measures:
Title
Change of Non-pharmacological Therapy Experience Scale (NPTES)
Description
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.
Time Frame
once per month within the intervention period

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kam Yuk, Claudia Lai, PhD
Organizational Affiliation
School of Nursing, The Hong Kong Polytechnic University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Shuk Ching, Jacqueline Ho, PhD
Organizational Affiliation
School of Nursing, The Hong Kong Polytechnic University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sze Ki, Daphne Cheung, PhD
Organizational Affiliation
School of Nursing, The Hong Kong Polytechnic University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Hong Kong Polytechnic University
City
Hong Kong
Country
Hong Kong

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
26354593
Citation
Lai CK, Lai DL, Ho JS, Wong KK, Cheung DS. Interdisciplinary collaboration in the use of a music-with-movement intervention to promote the wellbeing of people with dementia and their families: Development of an evidence-based intervention protocol. Nurs Health Sci. 2016 Mar;18(1):79-84. doi: 10.1111/nhs.12238. Epub 2015 Sep 10.
Results Reference
result

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Music-with-Movement Intervention for People With Early Dementia and Their Families

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