Dementia MildNCT04491578
An Advance Care Planning Programme for Persons With Early Stage Dementia in the Community
A study testing ACP programme "Have a Say" in people with Dementia Mild and Mild Cognitive Impairment, run by Hong Kong Metropolitan University at 10 sites in Hong Kong.
Trial summary
Advance care planning (ACP) has been widely advocated for persons with early stage dementia (PWEDs) and persons with mild cognitive impairment (MCI). 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… Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Dementia Mild, Mild Cognitive Impairment
- What is being tested?
- ACP programme "Have a Say"
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 10 sitesHong Kong
- Study dates
- 9 Jan 2021to 31 Oct 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- aged 55 years or over;
- being Chinese,
- being a Cantonese speaker,
- having a Global Deterioration Scale score 3 or 4,
- having a designated family caregiver willing to participate in this study
Who cannot join
- non-communicable,
- mentally incompetent,
- received an ACP intervention,
- have previously signed an advance directive,
- have other life-limiting chronic illnesses with a life expectancy of less than 6 months.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
Hong Kong10 sites
HKSKH Lok Man Alice Kwok Integrated Service Centre
Kowloon
Hong Kong Christian Service
Kowloon
Yang Memorial Methodist Social Service Choi Hung Community Centre for Senior Citizens
Kowloon
The Neighbourhood Advice-Action Council Sham Shui Po District Elderly Community Centre
Sham Shui Po
Jockey Club Centre for Positive Ageing
Shatin
The Neighbourhood Advice- Action Council Ma On Shan Neighbourhood Elderly Centre
Shatin
The Neighbourhood Advice-Action Council Tuen Mun District Integrated Services Centre for the Elderly
Tuenmen
Yau On Lutheran Centre for the Elderly
Tuenmen
HKSKH Chuk Yuen Canon Martin District Elderly Community Centre
Wong Tai Sin
Pentecostal Church of Hong Kong Ltd.Choi Wan Neighbourhood Elderly Centre
Wong Tai Sin
About this study
Official title: Effects of an Advance Care Planning Programme for Persons With Early Stage Dementia in the Community: A Quasi-experimental Study
Advance care planning (ACP) has been widely advocated for persons with early stage dementia (PWEDs) and persons with mild cognitive impairment (MCI). 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 received the intervention will be more engaged in ACP and their dyadic concordance on end-of-life care preference with their family caregivers will be higher after the intervention.
Read the detailed description
This study aims to evaluate the impacts of an advance care planning (ACP) programme "Have a Say" for persons with early stage dementia (PWEDs) or MCI and their family caregivers in the community. A quasi-experimental study with repeated blinded outcome assessment will be conducted to assess the effects of an ACP programme on dyads of PWEDs or persons with MCI 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 MCI or have a Global Deterioration Score (GDS) 3 or 4 will be eligible to this study. Participants 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. 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.
- Conditions
- Dementia Mild, Mild Cognitive Impairment
- Being tested
- ACP programme "Have a Say"
- Keywords
- advance care planning
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACP programme "Have a Say"Behavioural
Each dyad of participants will receive a 4-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 2 group-based sessions and 2 dyadic discussions. One hour for each session. The group-based sessions are nurse-led, in which 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. The dyadic sessions are led by trained ACP facilitator. Dyads of participants will be supported to have an individualized ACP discussion. By the end of the programme, each dyad of participants will be given an ACP booklet documenting the ACP process.
| Study group | Role | What they receive |
|---|---|---|
| ACP programme | Experimental | It is a theory-driven ACP programme specifically designed for PWEDs or persons with MCI and their family caregivers. The intervention is underpinned by the Bandura's self-efficacy model and shared decision-making model. Receives: Behavioral: ACP programme "Have a Say" |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, immediately after the intervention, 1 month follow up
Secondary outcomes (1)
Change in dyadic concordance of end-of-life care preferences
The dyadic concordance on end-of-life care preferences is measured by a modified Life Support Preferences Questionnaire (LSPQ). Dyads of participants are invited to answer individually, simultaneously but separately for a hypothetical scenario featured the prospect of developing into advanced stage of dementia. PWEDs are asked to indicate their preference for receiving three discrete life-sustaining medical treatments (cardio-pulmonary resuscitation, mechanical ventilation and tube feeding) using a 3 point Likert Scale (1=want to attempt; 2=refuse; 3= not sure). The dyadic congruence is determined based on whether both of them choose the same option for end-of-life treatments, regardless that was for active treatment or not, they gained a score of one. Given the nature of ACP is for the dyad to communicate preferences on end-of-life care, no score would be given if anyone in the dyad chose the "not sure" response.
Measured: Baseline, immediately after the intervention, 1 month follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2020
- Study start9 Jan 2021
- Primary completion31 Aug 2022
- Study completion31 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dementia MildStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Dyads of participants recruited from all elderly community centres will receive the ACP intervention
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hong Kong Metropolitan University
- Sponsor type
- University, hospital or other
- Collaborators
- Chinese University of Hong Kong, Food and Health Bureau, Hong Kong
- Responsible party
- Principal investigator, Ms Cheryl Yeung Chi Yan, Hong Kong Metropolitan University
- Investigators
- Chi Yan Cheryl Yeung, MN, Principal investigator, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04491578
- Sponsor's protocol ID
- HMRF 03180198
- Status last verified
- Mar 2023
- First submitted
- 6 Jun 2020
- Last updated
- 16 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of an Advance Care Planning Programme for Persons With Early Stage Dementia in the Community: A Quasi-experimental Study
- ClinicalTrials.gov ID
- NCT04491578
- Acronym / sponsor ID
- HMRF 03180198
- Conditions
- Dementia Mild, Mild Cognitive Impairment
- Keywords
- advance care planning
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Hong Kong Metropolitan UniversityUniversity, hospital or other
- Collaborators
- Chinese University of Hong Kong, Food and Health Bureau, Hong Kong
- Study start
- 9 Jan 2021 (actual)
- Primary completion
- 31 Aug 2022 (actual)
- Study completion
- 31 Oct 2022 (actual)
- First posted
- 29 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Advance care planning (ACP) has been widely advocated for persons with early stage dementia (PWEDs) and persons with mild cognitive impairment (MCI). 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 received the intervention will be more engaged in ACP and their dyadic concordance on end-of-life care preference with their family caregivers will be higher after the intervention.
Detailed description
This study aims to evaluate the impacts of an advance care planning (ACP) programme "Have a Say" for persons with early stage dementia (PWEDs) or MCI and their family caregivers in the community. A quasi-experimental study with repeated blinded outcome assessment will be conducted to assess the effects of an ACP programme on dyads of PWEDs or persons with MCI 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 MCI or have a Global Deterioration Score (GDS) 3 or 4 will be eligible to this study. Participants 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. 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.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Dyads of participants recruited from all elderly community centres will receive the ACP intervention
| Arm | Type | Receives |
|---|---|---|
| ACP programme | Experimental | Behavioral: ACP programme "Have a Say"It is a theory-driven ACP programme specifically designed for PWEDs or persons with MCI and their family caregivers. The intervention is underpinned by the Bandura's self-efficacy model and shared decision-making model. |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- aged 55 years or over;
- being Chinese,
- being a Cantonese speaker,
- having a Global Deterioration Scale score 3 or 4,
- having a designated family caregiver willing to participate in this study
Key exclusion criteria (5 listed)
- non-communicable,
- mentally incompetent,
- received an ACP intervention,
- have previously signed an advance directive,
- have other life-limiting chronic illnesses with a life expectancy of less than 6 months.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ACP programme "Have a Say"Each dyad of participants will receive a 4-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 2 group-based sessions and 2 dyadic discussions. One hour for each session. The group-based sessions are nurse-led, in which 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. The dyadic sessions are led by trained ACP facilitator. Dyads of participants will be supported to have an individualized ACP discussion. By the end of the programme, each dyad of participants will be given an ACP booklet documenting the ACP process. | Behavioural | ACP programme |
Primary outcome
Change in advance care planning engagement
Time frame: Baseline, immediately after the intervention, 1 month follow up
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.
1 secondary outcome
Change in dyadic concordance of end-of-life care preferences
Time frame: Baseline, immediately after the intervention, 1 month follow up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chi Yan Cheryl Yeung, MN principal investigator
Chinese University of Hong Kong
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ACP programme "Have a Say" in people with Dementia Mild and Mild Cognitive Impairment, run by Hong Kong Metropolitan University at 10 sites in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in advance care planning engagement (time frame: Baseline, immediately after the intervention, 1 month follow up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2023; AzTrials last refreshed its copy on 1 Nov 2026.