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

NCT ID: NCT03937297

Last Updated: 2023-05-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 216 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-04-23
• Study Completion Date: 2021-12-29

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.

Conditions

Dementia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Arm 1

Six Arts intervention

Group Type: EXPERIMENTAL

Six Arts

Intervention Type: 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 2

Cognitive Stimulation Therapy (CST)

Group Type: EXPERIMENTAL

Cognitive Stimulation Therapy (CST)

Intervention Type: 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 3

Usual care (control group)

Group Type: ACTIVE_COMPARATOR

Usual Care

Intervention Type: BEHAVIORAL

usual dementia care provided by participating center

Interventions

Six Arts

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

Cognitive Stimulation Therapy (CST)

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

Usual Care

usual dementia care provided by participating center

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• 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

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)

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hong Kong Alzheimer's Disease Association

UNKNOWN

Sponsor Role: collaborator

Chinese University of Hong Kong

OTHER

Sponsor Role: collaborator

The University of Hong Kong

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hoi Yan, Gloria Wong, PhD

Role: PRINCIPAL_INVESTIGATOR

non-med affiliation

Locations

The University of Hong Kong

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

Countries

Hong Kong

Other Identifiers

17612418

Identifier Type: -

Identifier Source: org_study_id