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DementiaNCT01976832

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

A study testing Music with movement and Social interaction in people with Dementia and Anxiety, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 65 years and older
Conditions the study is for
Dementia, Anxiety, Sleep
What is being tested?
Music with movement and Social interaction
Could I receive a placebo?
No, everyone receives an active treatment
How many people
95 participants
Where
1 siteHong Kong
Study dates
Jul 2014to Aug 2016
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 65 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • 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
Show all 14Show fewer
  • 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.

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Hong Kong1 site

  • The Hong Kong Polytechnic University

    Hong Kong

Other trials in Hong Kong

About this study

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.

Read more

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.

Being tested
Music with movement, Social interaction
Medical subject headings
Dementia, Anxiety Disorders, Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Music with movementBehavioural

    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 interactionBehavioural

    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 groups in NCT01976832
Study groupRoleWhat they receive
Music with movementExperimentalParticipants 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.
Receives: Behavioral: Music with movement
Social interactionActive comparatorThe 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.
Receives: Behavioral: Social interaction

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change of Rating anxiety in Dementia (RAID)

    For PWD only

    Comparisons of changes of RAID will be considered as follows:

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

    Measured: At baseline (T0), immediately post-intervention at 8-weeks (T1), and 8-weeks post-intervention (T2)

Secondary outcomes (12)

  1. Change of Geriatric Depression Scale (GDS)

    For PWD only

    Comparisons of changes of RAID will be considered as follows:

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

    Measured: At baseline (T0), immediately post-intervention at 8-weeks (T1), and 8-weeks post-intervention (T2)

  2. Change of Neuropsychiatric Inventory Questionnaire(NPI-Q)

    For PWD only

    Comparisons of changes of RAID will be considered as follows:

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

    Measured: At baseline (T0), immediately post-intervention at 8-weeks (T1), and 8-weeks post-intervention (T2)

  3. Change of Pittsburgh Sleep Quality Index (PQSI)

    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

    Measured: At baseline (T0), immediately post-intervention at 8-weeks (T1), and 8-weeks post-intervention (T2)

  4. Change of Quality of Life - Alzheimer's Disease (QOL-AD)

    For PWD only

    Comparisons of changes of RAID will be considered as follows:

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

    Measured: At baseline (T0), immediately post-intervention at 8-weeks (T1), and 8-weeks post-intervention (T2)

  5. Change of Patient Health Questionnaire 9 (PHQ-9)

    For Caregivers of PWD only

    Comparisons of changes of RAID will be considered as follows:

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

    Measured: At baseline (T0), immediately post-intervention at 8-weeks (T1), and 8-weeks post-intervention (T2)

  6. Change of Zarit Burden Scale (ZBS)

    For Caregivers of PWD only

    Comparisons of changes of RAID will be considered as follows:

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

    Measured: At baseline (T0), immediately post-intervention at 8-weeks (T1), and 8-weeks post-intervention (T2)

  7. 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:

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

    Measured: At baseline (T0), immediately post-intervention at 8-weeks (T1), and 8-weeks post-intervention (T2)

  8. Change of Generalized Anxiety Disorder 7

    For Caregivers of PWD only

    Comparisons of changes of RAID will be considered as follows:

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

    Measured: At baseline (T0), immediately post-intervention at 8-weeks (T1), and 8-weeks post-intervention (T2)

  9. Change of Mini-Mental State Examination (MMSE)

    For PWD only

    Comparisons of changes of RAID will be considered as follows:

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

    Measured: At baseline (T0), immediately post-intervention at 8-weeks (T1), and 8-weeks post-intervention (T2)

  10. Change of Revised Life Event Scale (RLES)

    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

    Measured: At baseline (T0), immediately post-intervention at 8-weeks (T1), and 8-weeks post-intervention (T2)

  11. Change of Lawton's Instrumental Activity of Daily Living (IADL)

    For PWD only

    Comparisons of changes of RAID will be considered as follows:

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

    Measured: At baseline (T0), immediately post-intervention at 8-weeks (T1), and 8-weeks post-intervention (T2)

  12. Change of Modified Barthel Index (MBI)

    For PWD only

    Comparisons of changes of RAID will be considered as follows:

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

    Measured: At baseline (T0), immediately post-intervention at 8-weeks (T1), and 8-weeks post-intervention (T2)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Nov 2013 (estimated)
  2. Study startJul 2014
  3. Primary completionMay 2016
  4. Study completionAug 2016

Resources

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
95 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01976832
Sponsor's protocol ID
5-ZH96
Status last verified
Sep 2016
First submitted
23 Oct 2013
Last updated
5 Sep 2016
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

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.

    PubMed 26354593

Questions about this trial

What is this clinical trial studying?

A study testing Music with movement and Social interaction in people with Dementia and Anxiety, 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 14 inclusion and 4 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: finished, as of the sponsor's last update on 5 Sep 2016. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01976832, which also lists 1 linked publication.

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 5 Sep 2016.

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