Clinical trial NCT05240664: Effects of An ACP Programme for Older People With Early Dementia
Official title: Effects of An Advance Care Planning Programme for Persons With Early Dementia And Their Family Caregivers in the Community
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dementia, Mild
Keywords: advance care planning
Lead sponsor: Hong Kong Metropolitan University
Sponsor class: OTHER
Collaborators: name: Chinese University of Hong Kong
First posted: 2022-02-15
Enrollment: 60
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Dyads of participants recruited from all elderly community centres will be randomized at block size equals to 4 in 1:1 ratio into intervention group and control group.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Advance care planning (ACP) has been widely advocated for persons with early stage dementia (PWEDs). This proposed study attempts to promote the uptake of ACP for this population and their family caregivers in the community and to examine the effects of an ACP programme "Have a Say" for this population. 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 evaluate the 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 randomized controlled trial with repeated blinded outcome assessment will be conducted to assess the effects of an ACP programme on dyads of PWEDs and their family caregivers recruited from elderly community centres. 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. Participants in the experimental group will receive a 4-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. Individuals assigned to the control group will receive attention-control health talks. The primary study outcome is the ACP engagement level of PWEDs. Secondary outcome is the dyadic concordance on end-of-life care preference. Adverse outcomes such as depression and caregivers' burden will also be evaluated. Data collection will be conducted at baseline, immediately after, and one-month after the intervention.

Eligibility criteria: Inclusion Criteria:

* being Chinese,
* being a Cantonese speaker,
* having a formal diagnosis of any form of dementia at the early stage, or having a Global Deterioration Scale score 3-4,
* having a designated family caregiver in direct contact and willing to participate in this study.

Exclusion Criteria:

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

A family caregiver involved in primary responsibility for caring and care-related decisions for the PWED will also be recruited. Paid caregivers are to be excluded.

Primary outcomes:
measure: Change in advance care planning engagement
timeFrame: Outcome will be measured at baseline, immediately after intervention, and 1-month after
Secondary outcomes:
measure: Change in dyadic concordance of preference on end-of-life care
timeFrame: Outcome will be measured at baseline, immediately after intervention, and 1-month after
measure: change in depression
timeFrame: Outcome will be measured at baseline, immediately after intervention, and 1-month after
measure: Change in caregivers' stress
timeFrame: Outcome will be measured at baseline, immediately after intervention, and 1-month after
Other outcomes:
Locations:
city: Kowloon
country: Hong Kong
facility: HKSKH Lok Man Alice Kwok Integrated Service Centre
city: Kowloon
country: Hong Kong
facility: Hong Kong Christian Service
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: Yang Memorial Methodist Social Service Choi Hung Community Centre for Senior Citizens
city: Sha Tin
country: Hong Kong
facility: Jockey Club Centre for Positive Ageing
city: Tuen Mun
country: Hong Kong
facility: Yau On Lutheran Centre for the Elderly
Study officials:
References:
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