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Dementia MildNCT04513106

Promoting Advance Care Planning for Persons With Early-stage Dementia in the Community: a Feasibility Trial

A study testing ACP programme "Have a Say" in people with Dementia Mild and Mild Cognitive Impairment, run by Hong Kong Metropolitan University at 5 sites in Hong Kong.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. 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"
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
36 participants
Where
5 sitesHong Kong
Study dates
9 Sep 2019to 30 Apr 2020
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

  • 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.

Who cannot join

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

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

Hong Kong5 sites

  • Hong Kong Family Welfare Society Kowloon City Centre for Active Ageing

    Kowloon

  • Hong Kong Sheng Kung Hui Chuk Yuen Canon Martin District Elderly Community Centre

    Kowloon

  • Hong Kong Sheng Kung Hui Lok Man Alice Kwok Integrated Service Centre

    Kowloon

  • Yang Memorial Methodist Social Service Choi Hung Community Centre for Senior Citizens

    Kowloon

  • Mrs. Wong Tung Yuen District Elderly Community Centre

    Yuen Long

Other trials in Hong Kong

About this study

Official title: Promoting Advance Care Planning in Persons With Early Stage Dementia and Their Family Caregivers in the Community: a Feasibility Trial

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.

Read the 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.

Being tested
ACP programme "Have a Say", Attention-control health talks
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

    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.

  • Attention-control health talksBehavioural

    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

Study groups in NCT04513106
Study groupRoleWhat they receive
Advance care planning programmeExperimentalIt 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.
Receives: Behavioral: ACP programme "Have a Say"
Attention controlPlacebo 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.
Receives: Behavioral: Attention-control health talks

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Baseline, immediately after the intervention, 1 month and 3 months follow up

Secondary outcomes (3)

  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 on two hypothetical scenarios, one featured the prospect of developing into advance stage of dementia, and another scenario featured the prospect of developing into an irreversible vegetative stage. PWEDs or persons with MCI are asked to consider themselves in each scenario and indicate their preference for receiving three discrete life-sustaining medical treatments (cardio-pulmonary resuscitation, mechanical ventilation and tube feeding) in each of the two scenarios using a 3 point Likert Scale (want to attempt, refuse or not sure). The dyadic congruence is determined based on whether both of them choose the same option for end-of-life treatments and care goals for the two scenarios. Score ranges from 0-8. A higher score means a higher level of dyadic concordance.

    Measured: Baseline, immediately after the intervention, 1 month and 3 months follow up

  2. Depression

    The level of depression of PWEDs or persons with MCI is measured by the 19-item Cornell Scale for Depression in Dementia (CSDD). It is to evaluate any adverse outcome posed by the intervention on them. The score ranges from 0-38. A cutoff point of nine or more indicating a depressive disorder, and a higher score means a higher depression level.

    Measured: Baseline, immediately after the intervention, 1 month and 3 months follow up

  3. Caregivers' stress

    Caregivers' stress is measured by the 12-item Zarit Caregiver Burden Interview. It is to evaluate any adverse outcome posed by the intervention on family caregivers. Score ranges from 0-48. A higher score means a higher level of caregiver burden.

    Measured: Baseline, immediately after the intervention, 1 month and 3 months follow up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Aug 2020
  2. Study start9 Sep 2019
  3. Primary completion30 Apr 2020
  4. Study completion30 Apr 2020

Resources

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
Non-randomised
Intervention model
Parallel groups
Model description
Participated elderly community centres will be assigned to intervention group or control group at a 1:1 ratio
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
36 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04513106
Sponsor's protocol ID
SIRCP R6303
Status last verified
Mar 2023
First submitted
11 Aug 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

Publications

  • 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.

    PubMed 36859250

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 5 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 5 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. Some participants in this study may receive a placebo. 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 and 3 months follow up). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04513106, which also lists 1 linked publication.

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.

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