Effectiveness-Implementation Cluster RCT to Improve Community-dwelling Early Dementia Patients by Music Intervention

NCT03575026 | Completed DMC

• 1 other identifier: 5-ZH2P
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

This is a 12-week cluster randomized controlled trial utilizing music-with-movement (MWM) intervention compared with usual care to investigate the effect of MWM among subjects with early dementia or mild cognitive impairment implemented by their caregivers at home.

Conditions

Dementia

Keywords

Early dementia; Caregiver; Anxiety; Well-being

Outcome Measures

Primary Outcomes (6)

• Changes in patients' anxiety

  Rating Anxiety in Dementia (RAID), total score (range 0-54), higher indicates higher anxiety level (score\>=11 indicates clinically significant anxiety)

  Baseline, immediate post-intervention (month 3)

• Changes in patients' depression

  Cornell scale for depression in dementia (CSDD), total score (range 0-36), higher indicates higher depression

  Baseline, immediate post-intervention (month 3)

• Changes in caregivers' stress and well-being

  Perceived Stress Scale 10 (PSS-10), total score (range 0-40), higher indicates higher perceived stress

  Baseline, immediate post-intervention (month 3)

• Changes in caregivers' stress

  Heart Rate Variability (HRV)

  Baseline, immediate post-intervention (month 3)

• Changes in caregivers' well-being

  Positive Aspects of Caregiving scale (PAC), total score (range 0-44), higher indicates more gain from caregiving experience

  Baseline, immediate post-intervention (month 3)

• Changes in caregivers' relationship with PWD

  Quality of the Caregiver-Care Recipient Relationship, 4 questions (range 0-4 each), higher score indicates better relationship between caregiver and care recipient

  Baseline, immediate post-intervention (month 3)

Secondary Outcomes (4)

• Changes in volunteers' satisfaction from volunteering

  Baseline, 3-month post-intervention (month 6)

• Changes in volunteers' expectation from volunteering

  Baseline, 3-month post-intervention (month 6)

• Changes in volunteers' knowledge towards dementia

  Baseline, 3-month post-intervention (month 6)

• Changes in volunteers' attitude towards dementia

  Baseline, 3-month post-intervention (month 6)

Other Outcomes (1)

• Feasibility of MWM intervention in community

  3-month post-intervention

Study Arms (2)

Intervention

EXPERIMENTAL

Subjects will receive 12-week music-with-movement intervention at home by their trained caregivers for 12 weeks, at least 3 sessions per week and 30 minutes for each session.

Behavioral: Music-with-movement

Wait-list control

PLACEBO COMPARATOR

Subjects will receive 12-week usual care (social activity) at home. Dose is similar to intervention arm. After the completion of 12-week usual care, subjects will receive the same music intervention as intervention arm.

Behavioral: Usual care

Interventions

Music-with-movement BEHAVIORAL

Subjects will listen their preferred music and move their body actively with music

Intervention

Usual care BEHAVIORAL

Social activity acts as control with similar dose and intensity with intervention arm

Wait-list control

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 60 or above
• Cognitively impaired, defined by Global Deterioration Scale 3 or 4
• Community-dwelling
• With stable medical condition
• Able to communicate in Cantonese
• have a family caregiver who was willing to take part in the study

You may not qualify if:

• Suffering from any critical medical or psychiatric illnesses
• Unable to hear even using hearing aids
• Unable to sit independently for around 30 minutes
• Received music intervention within 6 months
• Participate in any clinical trial within 6 months prior to the start of study
• Caregivers
• Primary caregiver of the PWeD
• Related to the PWeD and not a paid live-in care attendant
• Suffering from any critical medical or psychiatric illnesses
• Received music intervention within 6 months prior to the start of study

Sponsors & Collaborators

• The Hong Kong Polytechnic University: lead

Study Sites (1)

School of Nursing, The Hong Kong Polytechnic University

Hong Kong, Hong Kong

Location

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MeSH Terms

Conditions

Dementia; Anxiety Disorders

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant Professor

Study Record Dates

• First Submitted: April 11, 2018
• First Posted: July 2, 2018
• Study Start: April 18, 2018
• Primary Completion: July 31, 2019
• Study Completion: July 31, 2019
• Last Updated: September 28, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)