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

Primary Purpose

Dementia

Status
Completed
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Six Arts
Cognitive Stimulation Therapy (CST)
Usual Care
Sponsored by
The University of Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dementia focused on measuring non-pharmacological, intervention, culturally appropriate, Chinese, cognitive stimulation therapy, Six Arts, dementia, CST

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

People with dementia:

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)

Inclusion Criteria:

  • 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

Sites / Locations

  • The University of Hong Kong

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

Arm 1

Arm 2

Arm 3

Arm Description

Six Arts intervention

Cognitive Stimulation Therapy (CST)

Usual care (control group)

Outcomes

Primary Outcome Measures

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)
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

Secondary Outcome Measures

CDAD
measure the changes in functioning by using the Chinese version of the Disability Assessment for Dementia (CDAD), a 11-item scale that evaluates the basic and instrumental activities in daily activities of elderly people with dementia
NPI-Q
measure the changes in behavioral and psychological symptoms of dementia by using the Neuropsychological Inventory Questionnaire (NPI-Q), a 12-item informant-based interview

Full Information

First Posted
April 16, 2019
Last Updated
May 8, 2023
Sponsor
The University of Hong Kong
Collaborators
Hong Kong Alzheimer's Disease Association, Chinese University of Hong Kong
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1. Study Identification

Unique Protocol Identification Number
NCT03937297
Brief Title
A Culturally Appropriate Multimodal Non-pharmacological Intervention for Chinese People With Mild-to-Moderate Dementia
Official Title
A Culturally Appropriate Multimodal Non-pharmacological Intervention for Chinese People With Mild-to-Moderate Dementia
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
April 23, 2019 (Actual)
Primary Completion Date
December 29, 2021 (Actual)
Study Completion Date
December 29, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The University of Hong Kong
Collaborators
Hong Kong Alzheimer's Disease Association, Chinese University of Hong Kong

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Dementia is a disabling chronic condition affecting over 47 million people worldwide. Chinese population will be one of the main driver in the increasing trend in dementia prevalence. Accumulating evidence suggests effectiveness of certain non-drug interventions in maintaining cognition and quality of life in people with mild-to-moderate dementia, such as cognitive stimulation therapy (CST). These interventions are designed and tested in western populations with issues of cultural adaptation when applied in Chinese. Culturally appropriate and effective interventions for Chinese people with mild-to-moderate dementia are lacking. The Six Arts stem from ancient Confucian philosophy, which promotes behaviours that can impact on multiple mind-body functional domains. These domains correspond to social, physical, and cognitive activities with theoretical basis and empirical evidence of benefits in cognition, functioning, and quality of life. Using the Six Arts as a cultural framework, a group-based multimodal intervention has been developed in Hong Kong for Chinese people with mild-to-moderate dementia. The study will recruit 240 people with mild-to-moderate dementia in a randomized single-blind controlled trial consisting of three groups: (1) Six Arts intervention; (2) CST; and (3) usual care. Neuropsychological and clinical assessments will be conducted at randomization (T0/baseline) and upon completion of the 24-session, twice-weekly intervention (T1/3 months), by an assessor unaware of group membership. Focus groups will be conducted after completion of the intervention in 60 family caregivers who have observed at least one session of the Six Arts intervention or CST. This study will provide evidence on the effectiveness of two intervention protocols with potentials for large-scale implementation in the growing Chinese population with dementia.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dementia
Keywords
non-pharmacological, intervention, culturally appropriate, Chinese, cognitive stimulation therapy, Six Arts, dementia, CST

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
The assessor would not be told if the participant is in the intervention or control group
Allocation
Randomized
Enrollment
216 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm 1
Arm Type
Experimental
Arm Description
Six Arts intervention
Arm Title
Arm 2
Arm Type
Experimental
Arm Description
Cognitive Stimulation Therapy (CST)
Arm Title
Arm 3
Arm Type
Active Comparator
Arm Description
Usual care (control group)
Intervention Type
Behavioral
Intervention Name(s)
Six Arts
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Stimulation Therapy (CST)
Intervention Description
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)
Intervention Type
Behavioral
Intervention Name(s)
Usual Care
Intervention Description
usual dementia care provided by participating center
Primary Outcome Measure Information:
Title
Changes in quality of life of people with dementia
Description
measure by using a 13-item self-rating and proxy rating scale, the Quality of Life in Alzheimer's Disease (QoL-AD)
Time Frame
T0 (baseline), T1 (up to 4 months)
Title
Changes in cognitive performance
Description
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
Time Frame
T0 (baseline), T1 (up to 4 months)
Secondary Outcome Measure Information:
Title
CDAD
Description
measure the changes in functioning by using the Chinese version of the Disability Assessment for Dementia (CDAD), a 11-item scale that evaluates the basic and instrumental activities in daily activities of elderly people with dementia
Time Frame
T0 (baseline), T1 (up to 4 months)
Title
NPI-Q
Description
measure the changes in behavioral and psychological symptoms of dementia by using the Neuropsychological Inventory Questionnaire (NPI-Q), a 12-item informant-based interview
Time Frame
T0 (baseline), T1 (up to 4 months)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
People with dementia: Inclusion Criteria: 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 Exclusion Criteria: 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) Inclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hoi Yan, Gloria Wong, PhD
Organizational Affiliation
non-med affiliation
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Hong Kong
City
Hong Kong
State/Province
Non-US Or Canadian Address
Country
Hong Kong

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Not planning to share the data

Learn more about this trial

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

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