Clinical trial NCT01976832: 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
Overall status: COMPLETED
Phase: NA
Conditions: Dementia
Anxiety
Sleep
Depression
Quality of Life
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
First posted: 2013-11-06
Enrollment: 95
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Change of Rating anxiety in Dementia (RAID)
timeFrame: At baseline (T0), immediately post-intervention at 8-weeks (T1), and 8-weeks post-intervention (T2)
Secondary outcomes:
measure: Change of Geriatric Depression Scale (GDS)
timeFrame: At baseline (T0), immediately post-intervention at 8-weeks (T1), and 8-weeks post-intervention (T2)
measure: Change of Neuropsychiatric Inventory Questionnaire(NPI-Q)
timeFrame: At baseline (T0), immediately post-intervention at 8-weeks (T1), and 8-weeks post-intervention (T2)
measure: Change of Pittsburgh Sleep Quality Index (PQSI)
timeFrame: At baseline (T0), immediately post-intervention at 8-weeks (T1), and 8-weeks post-intervention (T2)
measure: Change of Quality of Life - Alzheimer's Disease (QOL-AD)
timeFrame: At baseline (T0), immediately post-intervention at 8-weeks (T1), and 8-weeks post-intervention (T2)
measure: Change of Patient Health Questionnaire 9 (PHQ-9)
timeFrame: At baseline (T0), immediately post-intervention at 8-weeks (T1), and 8-weeks post-intervention (T2)
measure: Change of Zarit Burden Scale (ZBS)
timeFrame: At baseline (T0), immediately post-intervention at 8-weeks (T1), and 8-weeks post-intervention (T2)
measure: Change of World Health Organization Quality of Life-BREF (WHOQOL-BREF)
timeFrame: At baseline (T0), immediately post-intervention at 8-weeks (T1), and 8-weeks post-intervention (T2)
measure: Change of Generalized Anxiety Disorder 7
timeFrame: At baseline (T0), immediately post-intervention at 8-weeks (T1), and 8-weeks post-intervention (T2)
measure: Change of Mini-Mental State Examination (MMSE)
timeFrame: At baseline (T0), immediately post-intervention at 8-weeks (T1), and 8-weeks post-intervention (T2)
measure: Change of Revised Life Event Scale (RLES)
timeFrame: At baseline (T0), immediately post-intervention at 8-weeks (T1), and 8-weeks post-intervention (T2)
measure: Change of Lawton's Instrumental Activity of Daily Living (IADL)
timeFrame: At baseline (T0), immediately post-intervention at 8-weeks (T1), and 8-weeks post-intervention (T2)
measure: Change of Modified Barthel Index (MBI)
timeFrame: At baseline (T0), immediately post-intervention at 8-weeks (T1), and 8-weeks post-intervention (T2)
Other outcomes:
measure: Change of Non-pharmacological Therapy Experience Scale (NPTES)
timeFrame: once per month within the intervention period
Locations:
city: Hong Kong
country: Hong Kong
facility: The Hong Kong Polytechnic University
Study officials:
affiliation: School of Nursing, The Hong Kong Polytechnic University
name: Kam Yuk, Claudia Lai, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: School of Nursing, The Hong Kong Polytechnic University
name: Shuk Ching, Jacqueline Ho, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: School of Nursing, The Hong Kong Polytechnic University
name: Sze Ki, Daphne Cheung, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.