Effects of An ACP Programme for Older People With Early Dementia
- Conditions
- Dementia, Mild
- Interventions
- Behavioral: Have A Say ProgrammeBehavioral: Attention-control health talks
- Registration Number
- NCT05240664
- Lead Sponsor
- Hong Kong Metropolitan University
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 60
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description ACP intervention Have A Say Programme It is a theory-driven ACP programme specifically designed for PWEDs and their family caregivers. The intervention is underpinned by the Bandura's self-efficacy model. Attention-control health talks Attention-control health talks Dyads of participants in the control group will receive health talks. This is to differentiate the effect of the intervention from the effect of the extra time and attention given to the participants.
- Primary Outcome Measures
Name Time Method Change in advance care planning engagement Outcome will be measured at baseline, immediately after intervention, and 1-month after The validated 9-item Advance Care Planning (ACP) Engagement Survey will be used to measure the engagement of PWED in the ACP process. Each item is measured on a five-point Likert scale and average 5-point scores will be calculated. It is originated from a longer version of 82 items measuring factors affecting the process of ACP engagement, including knowledge, contemplation, self-efficacy, and readiness. This shorter version reported sound psychometric properties and able to detect change across a broad range of ACP behaviours and ACP domains, with Cronbach's alpha =0.84, cross-sectional correlations =0.85, and delta correlations =0.68. The Chinese version of the ACP Engagement Survey is validated and reported sound psychometrical properties. This scale is composed of self-efficacy subscale and readiness subscale. Higher score reflects a higher level of ACP engagement.
- Secondary Outcome Measures
Name Time Method Change in dyadic concordance of preference on end-of-life care Outcome will be measured at baseline, immediately after intervention, and 1-month after The Life-Support Preferences Questionnaire will be used to measure the congruence on end-of-life care preferences between each participant dyad. This questionnaire has been modified and validated in the local context. The modified Chinese version of the Life Support Preferences Questionnaire was simplified to assess preferences regarding (i) three kinds of life-sustaining treatments (cardiopulmonary resuscitation, mechanical ventilator and tube feeding) based on three options (want to attempt, refuse or uncertain) and (ii) care goals (comfort-oriented, prolongation of life at all costs or uncertain) regarding a hypothetical end-of-life scenario (terminally ill). This scenario is based on the local advance directive form. Each member of the participated dyad will complete this questionnaire individually simultaneously. Higher score reflects a higher level of dyadic concordance.
change in depression Outcome will be measured at baseline, immediately after intervention, and 1-month after The Cornell Scale for Depression in Dementia will be used to measure the signs and symptoms of depression of PWEDs. It is a validated instrument for various severity levels of dementia patients. This is a 19-item instrument that uses information from interviews with family caregivers. The Chinese version of this instrument reported an expert content validity index as 0.92, and its concurrent validity with the Geriatric Depression Scale short form is 0.322 (p\<0.001). Its Cronbach's alpha for internal consistency reliability is 0.84. Higher score reflects a higher level of depression.
Change in caregivers' stress Outcome will be measured at baseline, immediately after intervention, and 1-month after The Zarit Caregiver Burden Interview (ZBI) will be used to measure the caregivers' stress. It has 12 items. The Cantonese short version of this instrument reported sound psychometric properties. Higher score reflects a higher level of caregivers' stress.
Trial Locations
- Locations (6)
Yau On Lutheran Centre for the Elderly
ðŸ‡ðŸ‡°Tuen Mun, Hong Kong
Hong Kong Christian Service
ðŸ‡ðŸ‡°Kowloon, Hong Kong
Jockey Club Centre for Positive Ageing
ðŸ‡ðŸ‡°Sha Tin, Hong Kong
HKSKH Lok Man Alice Kwok Integrated Service Centre
ðŸ‡ðŸ‡°Kowloon, Hong Kong
Hong Kong Sheng Kung Hui Chuk Yuen Canon Martin District Elderly Community Centre
ðŸ‡ðŸ‡°Kowloon, Hong Kong
Yang Memorial Methodist Social Service Choi Hung Community Centre for Senior Citizens
ðŸ‡ðŸ‡°Kowloon, Hong Kong