DementiaNCT06152120
Preparing Surrogates of Dementia Patients Through an Advance Care Planning Intervention
A study testing Nurse-facilitated advance care planning intervention in people with Dementia, run by The University of Hong Kong at 1 site in Hong Kong.
Trial summary
The goal of this clinical trial is to evaluate the effects of a nurse-facilitated post-discharge advance care planning intervention with family surrogates of dementia patients on outcomes that reflect the preparedness of surrogates in decision-making. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dementia
- What is being tested?
- Nurse-facilitated advance care planning intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteHong Kong
- Study dates
- 15 Jun 2023to 30 Sep 2024
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient (a) at or above the age of 60 years old, (b) with diagnosis of dementia based on DSM-5 Criteria for Major Neurocognitive Disorder and Stage 6d or above on the Functional Assessment Staging Tool (FAST), (c) residing in a residential care home that is participating in Hospital Authority Enhanced Community Geriatric Assessment Team End-of-Life (CGAT EOL) Care program and (d) has an eligible family decision-maker.
- Surrogate (a) at or above the age of 18 years old, (b) identified as the patient's next of kin or legal guardian who is the 'key decision maker' in hospital records, and (c) able to provide informed consent for him/herself and the patient.
Who cannot join
- Patient with (i) prior completed advance directive, (ii) On tube feeding at the time of index admission, (iii) currently enrolled in an end-of-life care program or palliative care service, or (iv) with family members who lack consensus on the primary family surrogate decision-maker.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Preparing Surrogates of Dementia Patients for In-the-moment Decision Making Through a Structured Advance Care Planning Intervention: A Mixed-methods Pilot Study
The goal of this clinical trial is to evaluate the effects of a nurse-facilitated post-discharge advance care planning intervention with family surrogates of dementia patients on outcomes that reflect the preparedness of surrogates in decision-making.
The main question it aims to answer is, whether the ACP intervention as compared with usual care will increase family surrogates' self-efficacy in surrogate decision-making and reduce their levels of distress, and increase patient comfort and reduce acute healthcare utilization at 2 and 6 months.
Read more
Participants will be randomized to ACP intervention vs. usual care.
- patients of the Intervention group will be assessed on palliative care needs, and surrogates of the Intervention group will participate in 2-3 nurse-led ACP consultations;
- surrogates of both intervention and control groups will complete 3 surveys at different time points during their participation of the study.
Researchers will compare the intervention group and control group to see any differences in:
- surrogate preparedness for decision-making,
- distress of surrogate and satisfaction with the care of loved one with dementia at the end-of-life,
- enrolment in Community Geriatric Assessment Team end-of-life care program,
- advanced care program documentation in medical record,
- patient comfort at end-of-life,
- hospitalizations in the last 6 months of life.
Read the detailed description
In order to test the ACP interventions that aim to engage surrogates' participation in ACP and improve their preparedness for decision-making rather than on documentation of advance care plans alone, the research team has developed a pilot structured, nurse-facilitated post-discharge ACP intervention with the aim to improve surrogates' preparedness for in-the-moment decision-making.
It does so by incorporating best practices for ACP communication, drawing from prior work of the research team and existing literature, combined with a focus on developing surrogates' self-efficacy for decision-making guided by Bandura's Social Cognitive Theory.
This application aims to test the intervention's effects on surrogate outcomes (decision-making self-efficacy and distress), patient outcomes (patient comfort and healthcare utilization), as well as process outcomes (ACP documentation, end-of-life care discussions between family members, and enrolment in end-of-life care programs).
The research hypotheses to be tested are as follows: the investigators will test whether the ACP intervention as compared with usual care will increase family surrogates' self-efficacy in surrogate decision-making and reduce their levels of distress, and increase patient comfort and reduce acute healthcare utilization at 2 and 6 months.
- Conditions
- Dementia
- Being tested
- Nurse-facilitated advance care planning intervention
- Keywords
- dementia, advance care planning
- Medical subject headings
- Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nurse-facilitated advance care planning interventionOther
The intervention consists of two components:
Component 1. Palliative care needs assessment - The research nurse will conduct a palliative care needs assessment and also review related information from the medical chart, which will enable the nurse to provide tailored information on the patient's illness, prognosis, and palliative care needs during subsequent ACP consultations.
Component 2: Structured nurse-facilitated ACP consultations - The research nurse will conduct post-discharge ACP consultations with the family surrogate, with content that includes: assess readiness for discussions, introduce video decision aides to provide related ACP information and share examples of family surrogates with similar experiences.
| Study group | Role | What they receive |
|---|---|---|
| ACP Intervention arm | Experimental | The intervention consists of two components:
1. Palliative care needs assessment During the patient's hospitalization, the ACP nurse facilitator will conduct a palliative care needs assessment including assessment of patient's dementia severity (using the FAST scale), symptoms, clinical condition, nutritional and functional status, as well as psychosocial information.
2. Structured nurse-facilitated post-discharge ACP consultations with use of video decisions aids
* ACP consultation 1 (1-2 weeks post discharge)
* Video decision aids (Between consultations 1 and 2)
* ACP consultation 2 (2-3 weeks post discharge)
* ACP consultation 3 (3-4 weeks post discharge), if needed
At the completion of the ACP intervention, the ACP nurse facilitator may refer patients to the CGAT EOL program via the link nurse if fulfill the program criteria and agreed by the family surrogate(s). Receives: Other: Nurse-facilitated advance care planning intervention |
| Usual care arm | No intervention | Patient and family surrogate dyads will receive usual hospital and post-discharge care. A publicly available information leaflet on advance care planning from the Hospital Authority's website will be given to control family surrogates after randomization. If a surrogate seeks assistance in discussing advance care planning, the research staff will advise the surrogate to speak with the patient's medical providers. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified Family Member Decision-Making Self-efficacy Scale (FDMSE) - Chinese version
This is a modified 17-item version of the FDMSE, a valid and reliable scale that quantifies a family member's confidence (0-100, where 100 = greatest self-efficacy) in end-of-life care decision-making for a loved one.
Measured: Baseline, 2-month, 6-month
Family Distress in Advanced Dementia Scale (FDAD) Dementia Preparedness Subscale - Chinese version
The FDAD is a validated 21-item scale rated on a 1-5 scale, with higher scores indicating greater family distress. The scale assesses three domains of distress of family members of nursing home residents with dementia: Emotional Distress, Dementia Preparedness, and Clinician Relations. The Chinese version of the FDAD has high content validity (CVI = 0.95). It has good internal consistency (Cronbach's alpha 0.83) and moderate test-retest reliability (ICC = 0.64).
We will use the 5-item Dementia Preparedness subscale to evaluate family distress associated with lack of knowledge of the course of dementia and surrogate medical decision making.
Measured: Baseline, 2-month, 6-month
Secondary outcomes (5)
End-of-life care discussions with other family members
The number of conversations which the surrogate has with other family members regarding end-of-life care decisions for the patient with advanced dementia.
Measured: Baseline, 2-month, 6-month
Documentation of ACP discussions with medical providers
Information on the date of ACP discussion, type of clinician(s) involved, and care decisions in the Hospital Authority Clinical Management System.
Measured: Baseline, 2-month, 6-month
Enrolment in Community Geriatric Assessment Team End-of-Life (CGAT EOL) care program
Occurrence and date of new enrolment in the CGAT EOL care program in the Hospital Authority Clinical Management System.
Measured: 2-month, 6-month
Comfort Assessment in Dying with Dementia (CAD-EOLD)
Measure of common symptoms and conditions to assess comfort of advanced dementia patients across 4 domains: Physical Distress, Emotional Distress, Well Being, and Dying Symptoms.
Measured: 2-month, 6-month
Unplanned hospital admissions and hospitalization days
The number of unplanned hospital admissions and hospitalization days in public and private hospitals.
Measured: 2-month, 6-month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2023
- Study start15 Jun 2023
- Primary completion30 Sep 2024
- Study completion30 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DementiaStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- The investigators will use a sequential mixed-methods approach including a pilot randomized controlled trial using a quantitative study to evaluate the effects of a structured nurse-facilitated ACP intervention and a qualitative study to explore the perceptions of the family surrogates and the ACP nurse facilitator on the ACP intervention. Each patient-family dyad will be randomized in a 1:1 ratio to ACP intervention vs. usual care before the baseline interview.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, YUEN Jacqueline Kwan Yuk, The University of Hong Kong
- Investigators
- Jacqueline Yuen, Dr, Principal investigator, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06152120
- Sponsor's protocol ID
- 20212481
- Status last verified
- Mar 2025
- First submitted
- 21 Nov 2023
- Last updated
- 14 May 2025
- 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 14 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preparing Surrogates of Dementia Patients for In-the-moment Decision Making Through a Structured Advance Care Planning Intervention: A Mixed-methods Pilot Study
- ClinicalTrials.gov ID
- NCT06152120
- Acronym / sponsor ID
- 20212481
- Conditions
- Dementia
- Keywords
- dementia, advance care planning
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 15 Jun 2023 (actual)
- Primary completion
- 30 Sep 2024 (actual)
- Study completion
- 30 Sep 2024 (actual)
- First posted
- 30 Nov 2023 (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.
The goal of this clinical trial is to evaluate the effects of a nurse-facilitated post-discharge advance care planning intervention with family surrogates of dementia patients on outcomes that reflect the preparedness of surrogates in decision-making.
The main question it aims to answer is, whether the ACP intervention as compared with usual care will increase family surrogates' self-efficacy in surrogate decision-making and reduce their levels of distress, and increase patient comfort and reduce acute healthcare utilization at 2 and 6 months.
Participants will be randomized to ACP intervention vs. usual care.
- patients of the Intervention group will be assessed on palliative care needs, and surrogates of the Intervention group will participate in 2-3 nurse-led ACP consultations;
- surrogates of both intervention and control groups will complete 3 surveys at different time points during their participation of the study.
Researchers will compare the intervention group and control group to see any differences in:
- surrogate preparedness for decision-making,
- distress of surrogate and satisfaction with the care of loved one with dementia at the end-of-life,
- enrolment in Community Geriatric Assessment Team end-of-life care program,
- advanced care program documentation in medical record,
- patient comfort at end-of-life,
- hospitalizations in the last 6 months of life.
Detailed description
In order to test the ACP interventions that aim to engage surrogates' participation in ACP and improve their preparedness for decision-making rather than on documentation of advance care plans alone, the research team has developed a pilot structured, nurse-facilitated post-discharge ACP intervention with the aim to improve surrogates' preparedness for in-the-moment decision-making.
It does so by incorporating best practices for ACP communication, drawing from prior work of the research team and existing literature, combined with a focus on developing surrogates' self-efficacy for decision-making guided by Bandura's Social Cognitive Theory.
This application aims to test the intervention's effects on surrogate outcomes (decision-making self-efficacy and distress), patient outcomes (patient comfort and healthcare utilization), as well as process outcomes (ACP documentation, end-of-life care discussions between family members, and enrolment in end-of-life care programs).
The research hypotheses to be tested are as follows: the investigators will test whether the ACP intervention as compared with usual care will increase family surrogates' self-efficacy in surrogate decision-making and reduce their levels of distress, and increase patient comfort and reduce acute healthcare utilization at 2 and 6 months.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- The investigators will use a sequential mixed-methods approach including a pilot randomized controlled trial using a quantitative study to evaluate the effects of a structured nurse-facilitated ACP intervention and a qualitative study to explore the perceptions of the family surrogates and the ACP nurse facilitator on the ACP intervention. Each patient-family dyad will be randomized in a 1:1 ratio to ACP intervention vs. usual care before the baseline interview.
| Arm | Type | Receives |
|---|---|---|
| ACP Intervention arm | Experimental | Other: Nurse-facilitated advance care planning interventionThe intervention consists of two components: 1. Palliative care needs assessment During the patient's hospitalization, the ACP nurse facilitator will conduct a palliative care needs assessment including assessment of patient's dementia severity (using the FAST scale), symptoms, clinical condition, nutritional and functional status, as well as psychosocial information. 2. Structured nurse-facilitated post-discharge ACP consultations with use of video decisions aids * ACP consultation 1 (1-2 weeks post discharge) * Video decision aids (Between consultations 1 and 2) * ACP consultation 2 (2-3 weeks post discharge) * ACP consultation 3 (3-4 weeks post discharge), if needed At the completion of the ACP intervention, the ACP nurse facilitator may refer patients to the CGAT EOL program via the link nurse if fulfill the program criteria and agreed by the family surrogate(s). |
| Usual care arm | No intervention | –Patient and family surrogate dyads will receive usual hospital and post-discharge care. A publicly available information leaflet on advance care planning from the Hospital Authority's website will be given to control family surrogates after randomization. If a surrogate seeks assistance in discussing advance care planning, the research staff will advise the surrogate to speak with the patient's medical providers. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patient (a) at or above the age of 60 years old, (b) with diagnosis of dementia based on DSM-5 Criteria for Major Neurocognitive Disorder and Stage 6d or above on the Functional Assessment Staging Tool (FAST), (c) residing in a residential care home that is participating in Hospital Authority Enhanced Community Geriatric Assessment Team End-of-Life (CGAT EOL) Care program and (d) has an eligible family decision-maker.
- Surrogate (a) at or above the age of 18 years old, (b) identified as the patient's next of kin or legal guardian who is the 'key decision maker' in hospital records, and (c) able to provide informed consent for him/herself and the patient.
Key exclusion criteria (1 listed)
- Patient with (i) prior completed advance directive, (ii) On tube feeding at the time of index admission, (iii) currently enrolled in an end-of-life care program or palliative care service, or (iv) with family members who lack consensus on the primary family surrogate decision-maker.
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 |
|---|---|---|
| Nurse-facilitated advance care planning interventionThe intervention consists of two components: Component 1. Palliative care needs assessment - The research nurse will conduct a palliative care needs assessment and also review related information from the medical chart, which will enable the nurse to provide tailored information on the patient's illness, prognosis, and palliative care needs during subsequent ACP consultations. Component 2: Structured nurse-facilitated ACP consultations - The research nurse will conduct post-discharge ACP consultations with the family surrogate, with content that includes: assess readiness for discussions, introduce video decision aides to provide related ACP information and share examples of family surrogates with similar experiences. | Other | ACP Intervention arm |
Primary outcome
Modified Family Member Decision-Making Self-efficacy Scale (FDMSE) - Chinese version
Time frame: Baseline, 2-month, 6-month
This is a modified 17-item version of the FDMSE, a valid and reliable scale that quantifies a family member's confidence (0-100, where 100 = greatest self-efficacy) in end-of-life care decision-making for a loved one.
Family Distress in Advanced Dementia Scale (FDAD) Dementia Preparedness Subscale - Chinese version
Time frame: Baseline, 2-month, 6-month
The FDAD is a validated 21-item scale rated on a 1-5 scale, with higher scores indicating greater family distress. The scale assesses three domains of distress of family members of nursing home residents with dementia: Emotional Distress, Dementia Preparedness, and Clinician Relations. The Chinese version of the FDAD has high content validity (CVI = 0.95). It has good internal consistency (Cronbach's alpha 0.83) and moderate test-retest reliability (ICC = 0.64). We will use the 5-item Dementia Preparedness subscale to evaluate family distress associated with lack of knowledge of the course of dementia and surrogate medical decision making.
5 secondary outcomes
End-of-life care discussions with other family members
Time frame: Baseline, 2-month, 6-month
Documentation of ACP discussions with medical providers
Time frame: Baseline, 2-month, 6-month
Enrolment in Community Geriatric Assessment Team End-of-Life (CGAT EOL) care program
Time frame: 2-month, 6-month
Comfort Assessment in Dying with Dementia (CAD-EOLD)
Time frame: 2-month, 6-month
Unplanned hospital admissions and hospitalization days
Time frame: 2-month, 6-month
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 14 May 2025.
- 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.
Jacqueline Yuen, Dr principal investigator
The University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nurse-facilitated advance care planning intervention in people with Dementia, run by The University of Hong Kong at 1 site 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 2 inclusion and 1 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 14 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Modified Family Member Decision-Making Self-efficacy Scale (FDMSE) - Chinese version (time frame: Baseline, 2-month, 6-month). The study lists 2 primary outcomes in all. 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 14 May 2025.