Clinical trial NCT03937297: 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
Overall status: COMPLETED
Phase: NA
Conditions: Dementia
Keywords: non-pharmacological
intervention
culturally appropriate
Chinese
cognitive stimulation therapy
Six Arts
dementia
CST
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
Collaborators: name: Hong Kong Alzheimer's Disease Association
name: Chinese University of Hong Kong
First posted: 2019-05-03
Enrollment: 216
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Changes in quality of life of people with dementia
timeFrame: T0 (baseline), T1 (up to 4 months)
measure: Changes in cognitive performance
timeFrame: T0 (baseline), T1 (up to 4 months)
Secondary outcomes:
measure: CDAD
timeFrame: T0 (baseline), T1 (up to 4 months)
measure: NPI-Q
timeFrame: T0 (baseline), T1 (up to 4 months)
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: The University of Hong Kong
state: Non-US Or Canadian Address
Study officials:
affiliation: non-med affiliation
name: Hoi Yan, Gloria Wong, PhD
role: PRINCIPAL_INVESTIGATOR
References: