A Culturally Appropriate Multimodal Non-pharmacological Intervention for Chinese People With Mild-to-Moderate Dementia

NCT03937297 | Completed

• 1 other identifier: 17612418
• Study Type: interventional
• Target: 216
• Locations: 1 country
• Sites: 1

Brief Summary

This is a mixed-methods research that includes a single-blind three-arms randomized control trials and a focus group study. The quantitative study aims to investigate the additional clinical benefits of the Six Arts intervention over an evidence-based non-pharmacological intervention translated from western culture, cognitive stimulation therapy (CST). The qualitative part aims to explore the acceptance and understanding of family caregiver of the Six Arts intervention and CST. It is hypothesized that 1) the group who have received Six Arts intervention would show superior quality of life; 2) both Six Arts and CST groups would show superior cognitive improvement compared with usual care; 3) the Six Arts group would show greater improvement in behavioral and neuropsychological symptoms and functioning compared with the groups receiving CST or usual care.

Conditions

Dementia

Keywords

non-pharmacological; intervention; culturally appropriate; Chinese; cognitive stimulation therapy; Six Arts; dementia; CST

Outcome Measures

Primary Outcomes (2)

• Changes in quality of life of people with dementia

  measure by using a 13-item self-rating and proxy rating scale, the Quality of Life in Alzheimer's Disease (QoL-AD)

  T0 (baseline), T1 (up to 4 months)

• Changes in cognitive performance

  measure by using the Alzheimer's Disease Assessment Scale - Cognitive section (ADAS-Cog), a standard cognitive test commonly used in clinical trials for people with dementia

  T0 (baseline), T1 (up to 4 months)

Secondary Outcomes (2)

• CDAD

  T0 (baseline), T1 (up to 4 months)

• NPI-Q

  T0 (baseline), T1 (up to 4 months)

Study Arms (3)

Arm 1

EXPERIMENTAL

Six Arts intervention

Behavioral: Six Arts

Arm 2

EXPERIMENTAL

Cognitive Stimulation Therapy (CST)

Behavioral: Cognitive Stimulation Therapy (CST)

Arm 3

ACTIVE COMPARATOR

Usual care (control group)

Behavioral: Usual Care

Interventions

Six Arts BEHAVIORAL

The Six Arts intervention is a 24 session, twice a week intervention protocol. There will be four sessions per "Art", with specific sequence designed to enhance group dynamic and create harmony. Each session starts with a 15 minutes warm-up exercise, followed by the Six Art theme activity. The program design emphasizes on integrated cognitive, physical, and social activities covering all domains of Six Arts.

Arm 1

Cognitive Stimulation Therapy (CST) BEHAVIORAL

The CST to be used involve 24 sessions of theme activities, twice a weekly intervention protocol. It is modified into CST-Hong Kong for activities that are not applicable in Hong Kong Chinese culture (e.g. word games involving alphabets)

Arm 2

Usual Care BEHAVIORAL

usual dementia care provided by participating center

Arm 3

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
• have clinical diagnosis of dementia or a Clinical Dementia Rating (CDR) of 1-2 suggestive of mild-to-moderate disease;
• able to communicate and understand communication, see and hear well enough to participate in a meaningful assessment;
• person with dementia and/or his/her caregiver can provide informed consent

You may not qualify if:

• suffering from major physical illness or disability that affect participation;
• had experience with the 24-session of CST or Six Arts intervention protocols
• Caregivers (for the focus group study)
• provide care to the person of dementia for more than 8 hours per week
• have observed at least one intervention session of either CST or Six Arts intervention

Sponsors & Collaborators

• The University of Hong Kong: lead
• Hong Kong Alzheimer's Disease Association: collaborator
• Chinese University of Hong Kong: collaborator

Study Sites (1)

The University of Hong Kong

Hong Kong, Non-US Or Canadian Address, Hong Kong

Location

MeSH Terms

Conditions

Dementia

Condition Hierarchy (Ancestors)

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

Study Officials

• Hoi Yan, Gloria Wong, PhD

  non-med affiliation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The assessor would not be told if the participant is in the intervention or control group
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 16, 2019
• First Posted: May 3, 2019
• Study Start: April 23, 2019
• Primary Completion: December 29, 2021
• Study Completion: December 29, 2021
• Last Updated: May 10, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)