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Completed

NCT Number: 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.

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Key information

Conditions

Dementia Anxiety Anxiety Disorders Behavior Behavioral Symptoms Brain Diseases Central Nervous System Diseases Depression Mental Disorders Nervous System Diseases Neurocognitive Disorders Quality of Life Sleep

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Hong Kong Polytechnic University

Hong Kong

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Music with movement

Behavioral

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

Behavioral

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 outcomes

  1. 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:

    • T1 - T0
    • T2 - T0
    • T2 - T1

Secondary outcomes

  1. 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:

    • T1 - T0
    • T2 - T0
    • T2 - T1

  2. 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:

    • T1 - T0
    • T2 - T0
    • T2 - T1

  3. 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:

    • T1 - T0
    • T2 - T0
    • T2 - T1

  4. 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:

    • T1 - T0
    • T2 - T0
    • T2 - T1

  5. 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:

    • T1 - T0
    • T2 - T0
    • T2 - T1

  6. 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:

    • T1 - T0
    • T2 - T0
    • T2 - T1

  7. 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:

    • T1 - T0
    • T2 - T0
    • T2 - T1

  8. 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:

    • T1 - T0
    • T2 - T0
    • T2 - T1

  9. 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:

    • T1 - T0
    • T2 - T0
    • T2 - T1

  10. 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:

    • T1 - T0
    • T2 - T0
    • T2 - T1

  11. 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:

    • T1 - T0
    • T2 - T0
    • T2 - T1

  12. 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:

    • T1 - T0
    • T2 - T0
    • T2 - T1

Other outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

The Hong Kong Polytechnic University

Other

Registry information

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Nov 6, 2013
Registry last updated
Sep 5, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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