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

• ClinicalTrials.gov Identifier: NCT01976832
• Recruitment Status: Completed
• First Posted: November 6, 2013
• Last Update Posted: September 5, 2016
• Sponsor: The Hong Kong Polytechnic University
• Information provided by (Responsible Party): Claudia K Y Lai, The Hong Kong Polytechnic University

Tracking Information

• First Submitted Date: October 23, 2013
• First Posted Date: November 6, 2013
• Last Update Posted Date: September 5, 2016
• Study Start Date: July 2014
• Actual Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: April 4, 2015)

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) ]

For PWD only Comparisons of changes of RAID will be considered as follows:

1. T1 - T0
2. T2 - T0
3. T2 - T1

Original Primary Outcome Measures (submitted: October 30, 2013)

Change of Rating anxiety in Dementia (RAID) [ Time Frame: At baseline (T0), mid-way in the intervention protocol (T1), immediately post-intervention at 12-weeks (T2), and 3 months post-intervention (T3) ]

For PWD only Comparisons of changes of RAID will be considered as follows:

1. T1 - T0
2. T2 - T0
3. T3 - T0
4. T2 - T1
5. T3 - T1
6. T3 - T2

Current Secondary Outcome Measures (submitted: April 4, 2015)

• 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:

  1. T1 - T0
  2. T2 - T0
  3. T2 - T1
• 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:

  1. T1 - T0
  2. T2 - T0
  3. T2 - T1
• 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) ]
  For PWD and Caregivers of PWD only Comparisons of changes of RAID will be considered as follows:

  1. T1 - T0
  2. T2 - T0
  3. T2 - T1
• 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) ]
  For PWD only Comparisons of changes of RAID will be considered as follows:

  1. T1 - T0
  2. T2 - T0
  3. T2 - T1
• 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) ]
  For Caregivers of PWD only Comparisons of changes of RAID will be considered as follows:

  1. T1 - T0
  2. T2 - T0
  3. T2 - T1
• Change of Zarit Burden Scale (ZBS) [ Time Frame: At baseline (T0), immediately post-intervention at 8-weeks (T1), and 8-weeks post-intervention (T2) ]
  For Caregivers of PWD only Comparisons of changes of RAID will be considered as follows:

  1. T1 - T0
  2. T2 - T0
  3. T2 - T1
• 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) ]
  For Caregivers of PWD only Comparisons of changes of RAID will be considered as follows:

  1. T1 - T0
  2. T2 - T0
  3. T2 - T1
• Change of Generalized Anxiety Disorder 7 [ Time Frame: At baseline (T0), immediately post-intervention at 8-weeks (T1), and 8-weeks post-intervention (T2) ]
  For Caregivers of PWD only Comparisons of changes of RAID will be considered as follows:

  1. T1 - T0
  2. T2 - T0
  3. T2 - T1
• 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) ]
  For PWD only Comparisons of changes of RAID will be considered as follows:

  1. T1 - T0
  2. T2 - T0
  3. T2 - T1
• 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) ]
  For PWD and Caregivers of PWD Comparisons of changes of RAID will be considered as follows:

  1. T1 - T0
  2. T2 - T0
  3. T2 - T1
• 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) ]
  For PWD only Comparisons of changes of RAID will be considered as follows:

  1. T1 - T0
  2. T2 - T0
  3. T2 - T1
• Change of Modified Barthel Index (MBI) [ 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:

  1. T1 - T0
  2. T2 - T0
  3. T2 - T1

Original Secondary Outcome Measures (submitted: October 30, 2013)

• Change of Geriatric Depression Scale (GDS) [ Time Frame: At baseline (T0), mid-way in the intervention protocol (T1), immediately post-intervention at 12-weeks (T2), and 3 months post-intervention (T3) ]
  For PWD only Comparisons of changes of RAID will be considered as follows:

  1. T1 - T0
  2. T2 - T0
  3. T3 - T0
  4. T2 - T1
  5. T3 - T1
  6. T3 - T2
• Change of Neuropsychiatric Inventory - Community version (NPI) [ Time Frame: At baseline (T0), mid-way in the intervention protocol (T1), immediately post-intervention at 12-weeks (T2), and 3 months post-intervention (T3) ]
  For PWD only Comparisons of changes of RAID will be considered as follows:

  1. T1 - T0
  2. T2 - T0
  3. T3 - T0
  4. T2 - T1
  5. T3 - T1
  6. T3 - T2
• Change of Pittsburgh Sleep Quality Index (PQSI) [ Time Frame: At baseline (T0), mid-way in the intervention protocol (T1), immediately post-intervention at 12-weeks (T2), and 3 months post-intervention (T3) ]
  For PWD and Caregivers of PWD only Comparisons of changes of RAID will be considered as follows:

  1. T1 - T0
  2. T2 - T0
  3. T3 - T0
  4. T2 - T1
  5. T3 - T1
  6. T3 - T2
• Change of Quality of Life - Alzheimer's Disease (QOL-AD) [ Time Frame: At baseline (T0), mid-way in the intervention protocol (T1), immediately post-intervention at 12-weeks (T2), and 3 months post-intervention (T3) ]
  For PWD only Comparisons of changes of RAID will be considered as follows:

  1. T1 - T0
  2. T2 - T0
  3. T3 - T0
  4. T2 - T1
  5. T3 - T1
  6. T3 - T2
• Hospital Anxiety and Depression Scale (HADS) [ Time Frame: At baseline (T0), mid-way in the intervention protocol (T1), immediately post-intervention at 12-weeks (T2), and 3 months post-intervention (T3) ]
  For Caregivers of PWD only Comparisons of changes of RAID will be considered as follows:

  1. T1 - T0
  2. T2 - T0
  3. T3 - T0
  4. T2 - T1
  5. T3 - T1
  6. T3 - T2
• Change of Zarit Burden Scale [ Time Frame: At baseline (T0), mid-way in the intervention protocol (T1), immediately post-intervention at 12-weeks (T2), and 3 months post-intervention (T3) ]
  For Caregivers of PWD only Comparisons of changes of RAID will be considered as follows:

  1. T1 - T0
  2. T2 - T0
  3. T3 - T0
  4. T2 - T1
  5. T3 - T1
  6. T3 - T2
• Change of World Health Organization Quality of Life-BREF (WHOQOL-BREF) [ Time Frame: At baseline (T0), mid-way in the intervention protocol (T1), immediately post-intervention at 12-weeks (T2), and 3 months post-intervention (T3) ]
  For Caregivers of PWD only Comparisons of changes of RAID will be considered as follows:

  1. T1 - T0
  2. T2 - T0
  3. T3 - T0
  4. T2 - T1
  5. T3 - T1
  6. T3 - T2

Current Other Pre-specified Outcome Measures (submitted: October 30, 2013)

Change of Non-pharmacological Therapy Experience Scale (NPTES) [ Time Frame: once per month within the intervention period ]

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.

• Original Other Pre-specified Outcome Measures: Same as current

Descriptive Information

• 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

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.

• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Outcomes Assessor); Primary Purpose: Treatment

Condition

• Dementia
• Anxiety
• Sleep
• Depression
• Quality of Life

Intervention

• Behavioral: Music with movement
  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.
• Behavioral: 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.

Study Arms

• 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.
  Intervention: Behavioral: Music with movement
• 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.

  Intervention: Behavioral: Social interaction

• Publications *: 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: September 1, 2016): 95
• Original Estimated Enrollment (submitted: October 30, 2013): 134
• Actual Study Completion Date: August 2016
• Actual Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 65 Years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Hong Kong

Administrative Information

• NCT Number: NCT01976832
• Other Study ID Numbers: 5-ZH96
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Claudia K Y Lai, The Hong Kong Polytechnic University
• Original Responsible Party: Same as current
• Current Study Sponsor: The Hong Kong Polytechnic University
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

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

• PRS Account: The Hong Kong Polytechnic University
• Verification Date: September 2016