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

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01976832
• Other study ID #: 5-ZH96
• Status: Completed
• Phase: N/A
• First received: October 23, 2013
• Last updated: September 1, 2016
• Start date: July 2014
• Est. completion date: August 2016

Study information

• Verified date: September 2016
• Source: The Hong Kong Polytechnic University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Hong Kong: Department of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 95
• Est. completion date: August 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

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

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.
• 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.

Locations

Country	Name	City	State
Hong Kong	The Hong Kong Polytechnic University	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
The Hong Kong Polytechnic University

Country where clinical trial is conducted

Hong Kong, 

References & Publications (1)

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 H — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change of Non-pharmacological Therapy Experience Scale (NPTES)	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.	once per month within the intervention period	No
Primary	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	At baseline (T0), immediately post-intervention at 8-weeks (T1), and 8-weeks post-intervention (T2)	No
Secondary	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	At baseline (T0), immediately post-intervention at 8-weeks (T1), and 8-weeks post-intervention (T2)	No
Secondary	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	At baseline (T0), immediately post-intervention at 8-weeks (T1), and 8-weeks post-intervention (T2)	No
Secondary	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	At baseline (T0), immediately post-intervention at 8-weeks (T1), and 8-weeks post-intervention (T2)	No
Secondary	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	At baseline (T0), immediately post-intervention at 8-weeks (T1), and 8-weeks post-intervention (T2)	No
Secondary	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	At baseline (T0), immediately post-intervention at 8-weeks (T1), and 8-weeks post-intervention (T2)	No
Secondary	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	At baseline (T0), immediately post-intervention at 8-weeks (T1), and 8-weeks post-intervention (T2)	No
Secondary	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	At baseline (T0), immediately post-intervention at 8-weeks (T1), and 8-weeks post-intervention (T2)	No
Secondary	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	At baseline (T0), immediately post-intervention at 8-weeks (T1), and 8-weeks post-intervention (T2)	No
Secondary	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	At baseline (T0), immediately post-intervention at 8-weeks (T1), and 8-weeks post-intervention (T2)	No
Secondary	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	At baseline (T0), immediately post-intervention at 8-weeks (T1), and 8-weeks post-intervention (T2)	No
Secondary	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	At baseline (T0), immediately post-intervention at 8-weeks (T1), and 8-weeks post-intervention (T2)	No
Secondary	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	At baseline (T0), immediately post-intervention at 8-weeks (T1), and 8-weeks post-intervention (T2)	No