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

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ClinicalTrials.gov Identifier: NCT03937297
Recruitment Status : Recruiting
First Posted : May 3, 2019
Last Update Posted : May 3, 2019
Sponsor:
Collaborators:
Hong Kong Alzheimer's Disease Association
Chinese University of Hong Kong
Information provided by (Responsible Party):
The University of Hong Kong

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.


Condition or disease Intervention/treatment Phase
Dementia Behavioral: Six Arts Behavioral: Cognitive Stimulation Therapy (CST) Behavioral: Usual Care Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking Description: The assessor would not be told if the participant is in the intervention or control group
Primary Purpose: Treatment
Official Title: A Culturally Appropriate Multimodal Non-pharmacological Intervention for Chinese People With Mild-to-Moderate Dementia
Actual Study Start Date : April 23, 2019
Estimated Primary Completion Date : November 15, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dementia

Arm Intervention/treatment
Experimental: Arm 1
Six Arts intervention
Behavioral: 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.

Experimental: Arm 2
Cognitive Stimulation Therapy (CST)
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)

Active Comparator: Arm 3
Usual care (control group)
Behavioral: Usual Care
usual dementia care provided by participating center




Primary Outcome Measures :
  1. Changes in quality of life of people with dementia [ Time Frame: T0 (baseline), T1 (up to 4 months) ]
    measure by using a 13-item self-rating and proxy rating scale, the Quality of Life in Alzheimer's Disease (QoL-AD)

  2. Changes in cognitive performance [ Time Frame: T0 (baseline), T1 (up to 4 months) ]
    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 :
  1. CDAD [ Time Frame: T0 (baseline), T1 (up to 4 months) ]
    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

  2. NPI-Q [ Time Frame: T0 (baseline), T1 (up to 4 months) ]
    measure the changes in behavioral and psychological symptoms of dementia by using the Neuropsychological Inventory Questionnaire (NPI-Q), a 12-item informant-based interview



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03937297


Contacts
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Contact: Emily Leung, MPH (852)3917-0080 emleung@hku.hk
Contact: Mandy Lau, MSc (852)3917-1760 mlau@hku.hk

Locations
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Hong Kong
The University of Hong Kong Recruiting
Hong Kong, Non-US Or Canadian Address, Hong Kong
Contact: Gloria Wong, PhD    39172074    ghywong@hku.hk   
Sponsors and Collaborators
The University of Hong Kong
Hong Kong Alzheimer's Disease Association
Chinese University of Hong Kong
Investigators
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Principal Investigator: Hoi Yan, Gloria Wong, PhD non-med affiliation
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Responsible Party: The University of Hong Kong
ClinicalTrials.gov Identifier: NCT03937297    
Other Study ID Numbers: 17612418
First Posted: May 3, 2019    Key Record Dates
Last Update Posted: May 3, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Not planning to share the data

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by The University of Hong Kong:
non-pharmacological
intervention
culturally appropriate
Chinese
cognitive stimulation therapy
Six Arts
dementia
CST
Additional relevant MeSH terms:
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Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders