Promoting Advance Care Planning for Persons With Early-stage Dementia in the Community: a Feasibility Trial
1 other identifier
interventional
36
1 country
5
Brief Summary
Advance care planning (ACP) has been widely advocated to persons with early stage dementia (PWEDs). This feasibility trial aims to test a theory-based ACP programme "Have a Say" specifically designed for this population, which is underpinned by the Bandura's self-efficacy model. It is the first of its kind in Hong Kong and will be conducted in the community through medical-social collaboration. The aim of this study is to test the feasibility and preliminary effects of the "Have a Say" programme. It is hypothesized that participants in the intervention group will be more engaged in ACP and their dyadic concordance on end-of-life care preference with their family caregivers will be significantly higher than that in the control group.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Sep 2019
Shorter than P25 for not_applicable
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 9, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
April 30, 2020
CompletedFirst Submitted
Initial submission to the registry
August 11, 2020
CompletedFirst Posted
Study publicly available on registry
August 14, 2020
CompletedMarch 16, 2023
March 1, 2023
8 months
August 11, 2020
March 14, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in advance care planning engagement
The behavior change process in ACP behaviours is measured using a 9-item ACP engagement survey. It covers two sub-scales, self-efficacy and readiness, of ACP engagement. Each item is rated on a 5-point likert scale. The higher score means the higher level of engagement for the ACP behaviour.
Baseline, immediately after the intervention, 1 month and 3 months follow up
Secondary Outcomes (3)
Change in dyadic concordance of end-of-life care preferences
Baseline, immediately after the intervention, 1 month and 3 months follow up
Depression
Baseline, immediately after the intervention, 1 month and 3 months follow up
Caregivers' stress
Baseline, immediately after the intervention, 1 month and 3 months follow up
Other Outcomes (4)
Subject recruitment rate
Baseline
Subject attrition rate
Immediately after the intervention, 1 month and 3 months follow up
Completion rate
Immediately after the intervention
- +1 more other outcomes
Study Arms (2)
Advance care planning programme
EXPERIMENTALIt is a theory-driven advance care planning programme specifically designed for PWEDs and their family caregivers. The intervention is underpinned by the Bandura's self-efficacy model. Each dyad of participants will receive a 3-session ACP programme, which consists of educational components, guided reflection, and dyadic ACP discussion, guided by ACP facilitators and an ACP booklet. It is composed of 1 group-based sessions and 2 dyadic discussions. One hour for each session, and once weekly. Dyads of participants will be provided with information about the trajectory of dementia, their future healthcare needs and caring options. Their values and care preferences on future care will be elicited in a consistent manner. They will be supported to have an individualized ACP discussion. By the end of the programme, each dyad of participant will be given an ACP booklet documenting the ACP process.
Attention control
PLACEBO COMPARATORDyads of participants in the control group will receive 3-session health talks. One hour for each session, and once weekly. The contents of the health talks are neither dementia-specific nor related to ACP, and cover general health information for elderly, such as drug safety, home safety, exercise and health. This is to differentiate the effect of the intervention from the effect of the extra time and attention given to the participants.
Interventions
It is a theory-driven advance care planning programme specifically designed for PWEDs or persons with MCI and their family caregivers. The intervention is underpinned by the Bandura's self-efficacy model. Each dyad of participants will receive a 3-session ACP programme, which consists of educational components, guided reflection, and dyadic ACP discussion, guided by ACP facilitators and an ACP booklet. It is composed of 1 group-based sessions and 2 dyadic discussions. One hour for each session, and once weekly. Dyads of participants will be provided with information about the trajectory of dementia, their future healthcare needs and caring options. Their values and care preferences on future care will be elicited in a consistent manner. They will be supported to have an individualized ACP discussion. By the end of the programme, each dyad of participant will be given an ACP booklet documenting the ACP process.
Dyads of participants in the control group will receive 3-session health talks. One hour for each session, and once weekly. The contents of the health talks are neither dementia-specific nor related to ACP, and cover general health information for elderly, such as drug safety, home safety, exercise and health. This is to differentiate the effect of the intervention from the effect of the extra time and attention given to the participants
Eligibility Criteria
You may qualify if:
- being Chinese,
- being a Cantonese speaker,
- having a formal diagnosis of early stage dementia,
- having a Global Deterioration Scale score 3-4,
- having a designated family caregiver in direct contact.
You may not qualify if:
- non-communicable,
- mentally incompetent,
- received an ACP intervention,
- have previously signed an advance directive,
- have other life-limiting chronic illnesses.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Hong Kong Metropolitan Universitylead
- Chinese University of Hong Kongcollaborator
- The British Council in Hong Kongcollaborator
Study Sites (5)
Hong Kong Family Welfare Society Kowloon City Centre for Active Ageing
Kowloon, Hong Kong
Hong Kong Sheng Kung Hui Chuk Yuen Canon Martin District Elderly Community Centre
Kowloon, Hong Kong
Hong Kong Sheng Kung Hui Lok Man Alice Kwok Integrated Service Centre
Kowloon, Hong Kong
Yang Memorial Methodist Social Service Choi Hung Community Centre for Senior Citizens
Kowloon, Hong Kong
Mrs. Wong Tung Yuen District Elderly Community Centre
Yuen Long, Hong Kong
Related Publications (1)
Yeung CC, Ho KH, Chan HY. A dyadic advance care planning intervention for people with early-stage dementia and their family caregivers in a community care setting: a feasibility trial. BMC Geriatr. 2023 Mar 1;23(1):115. doi: 10.1186/s12877-023-03815-3.
PMID: 36859250DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Chi Yan Cheryl Yeung, MN
Chinese University of Hong Kong
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- Outcome assessors will be blinded to group assignment of participants, and the research question.
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Senior Lecturer
Study Record Dates
First Submitted
August 11, 2020
First Posted
August 14, 2020
Study Start
September 9, 2019
Primary Completion
April 30, 2020
Study Completion
April 30, 2020
Last Updated
March 16, 2023
Record last verified: 2023-03
Data Sharing
- IPD Sharing
- Will not share