Clinical trial NCT04513106: Promoting Advance Care Planning for Persons With Early-stage Dementia in the Community: a Feasibility Trial
Official title: Promoting Advance Care Planning in Persons With Early Stage Dementia and Their Family Caregivers in the Community: a Feasibility Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dementia Mild
Mild Cognitive Impairment
Keywords: advance care planning
Lead sponsor: Hong Kong Metropolitan University
Sponsor class: OTHER
Collaborators: name: Chinese University of Hong Kong
name: The British Council in Hong Kong
First posted: 2020-08-14
Enrollment: 36
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participated elderly community centres will be assigned to intervention group or control group at a 1:1 ratio
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Detailed description: This study aims to test the feasibility and preliminary effects of an advance care planning (ACP) programme "Have a Say" for persons with early stage dementia (PWEDs) and their family caregivers in the community. A quasi-experimental pretest-posttest study with a control group with repeated blinded outcome assessment will be conducted.

Individuals who have a clinical diagnosis of any form of dementia at the early stage or have a Global Deterioration Score (GDS) 3 or 4 will be eligible to this study. Participated elderly community centres will be assigned to intervention group and control group at 1:1 ratio. Staff members from centres assigned to intervention group will be trained as ACP facilitators and conduct the ACP intervention. Participants in the experimental group will receive a 3-session ACP programme. It includes an educational component, guided reflection and ACP discussion through a series of group-based activity and dyadic discussion delivered by trained ACP facilitator and guided by an ACP booklet. 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 led by ACP facilitators and guided by an ACP booklet. Individuals assigned to the control group will receive attention-control health talks related to ageing. The feasibility of the trial design (in terms of subject recruitment and retention rate) and study instruments (in terms of data completness), and acceptability of intervention procedures (in terms of completion rate and satisfaction score) will be assessed.

As a process evaluation, a group of informants comprised of ACP facilitators and dyads of participants will be conveniently sampled and recruited for an semi-structured individual interview after receiving the intervention. Their experiences of participating in "Have a Say" programme as an ACP facilitator and participants will be explored. Qualitative data will be collected until data saturation. All verbatim will be transcribed and analyzed through qualitative content analysis. The results of this qualitative evaluation will enable us to understand the strengths and weaknesses of this ACP programme during implementation and give us insight about the mechanisms of impact and contextual factors affecting the intervention implementation, sustainability, and outcomes.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* non-communicable,
* mentally incompetent,
* received an ACP intervention,
* have previously signed an advance directive,
* have other life-limiting chronic illnesses.

Primary outcomes:
measure: Change in advance care planning engagement
timeFrame: Baseline, immediately after the intervention, 1 month and 3 months follow up
Secondary outcomes:
measure: Change in dyadic concordance of end-of-life care preferences
timeFrame: Baseline, immediately after the intervention, 1 month and 3 months follow up
measure: Depression
timeFrame: Baseline, immediately after the intervention, 1 month and 3 months follow up
measure: Caregivers' stress
timeFrame: Baseline, immediately after the intervention, 1 month and 3 months follow up
Other outcomes:
measure: Subject recruitment rate
timeFrame: Baseline
measure: Subject attrition rate
timeFrame: Immediately after the intervention, 1 month and 3 months follow up
measure: Completion rate
timeFrame: Immediately after the intervention
measure: Satisfaction score
timeFrame: Immediately after the intervention
Locations:
city: Kowloon
country: Hong Kong
facility: Hong Kong Family Welfare Society Kowloon City Centre for Active Ageing
city: Kowloon
country: Hong Kong
facility: Hong Kong Sheng Kung Hui Chuk Yuen Canon Martin District Elderly Community Centre
city: Kowloon
country: Hong Kong
facility: Hong Kong Sheng Kung Hui Lok Man Alice Kwok Integrated Service Centre
city: Kowloon
country: Hong Kong
facility: Yang Memorial Methodist Social Service Choi Hung Community Centre for Senior Citizens
city: Yuen Long
country: Hong Kong
facility: Mrs. Wong Tung Yuen District Elderly Community Centre
Study officials:
affiliation: Chinese University of Hong Kong
name: Chi Yan Cheryl Yeung, MN
role: PRINCIPAL_INVESTIGATOR
References: