- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04491578
An Advance Care Planning Programme for Persons With Early Stage Dementia in the Community
March 14, 2023 updated by: Ms Cheryl Yeung Chi Yan, Hong Kong Metropolitan University
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
100
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Kowloon, Hong Kong
- Yang Memorial Methodist Social Service Choi Hung Community Centre for Senior Citizens
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Kowloon, Hong Kong
- HKSKH Lok Man Alice Kwok Integrated Service Centre
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Kowloon, Hong Kong
- Hong Kong Christian Service
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Sha Tin, Hong Kong
- Jockey Club Centre for Positive Ageing
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Sha Tin, Hong Kong
- The Neighbourhood Advice- Action Council Ma On Shan Neighbourhood Elderly Centre
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Sham Shui Po, Hong Kong
- The Neighbourhood Advice-Action Council Sham Shui Po District Elderly Community Centre
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Tuen Mun, Hong Kong
- The Neighbourhood Advice-Action Council Tuen Mun District Integrated Services Centre for the Elderly
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Tuen Mun, Hong Kong
- Yau On Lutheran Centre for the Elderly
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Wong Tai Sin, Hong Kong
- HKSKH Chuk Yuen Canon Martin District Elderly Community Centre
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Wong Tai Sin, Hong Kong
- Pentecostal Church of Hong Kong Ltd.Choi Wan Neighbourhood Elderly Centre
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
55 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: ACP programme
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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in advance care planning engagement
Time Frame: Baseline, immediately after the intervention, 1 month follow up
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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.
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Baseline, immediately after the intervention, 1 month follow up
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in dyadic concordance of end-of-life care preferences
Time Frame: Baseline, immediately after the intervention, 1 month follow up
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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.
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Baseline, immediately after the intervention, 1 month follow up
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Caregivers' stress
Time Frame: Baseline, immediately after the intervention, 1 month follow up
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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.
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Baseline, immediately after the intervention, 1 month follow up
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Depression
Time Frame: Baseline, immediately after the intervention, 1 month follow up
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The level of depression of PWEDs 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.
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Baseline, immediately after the intervention, 1 month follow up
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Chi Yan Cheryl Yeung, MN, Chinese University of Hong Kong
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 9, 2021
Primary Completion (Actual)
August 31, 2022
Study Completion (Actual)
October 31, 2022
Study Registration Dates
First Submitted
June 6, 2020
First Submitted That Met QC Criteria
July 28, 2020
First Posted (Actual)
July 29, 2020
Study Record Updates
Last Update Posted (Actual)
March 16, 2023
Last Update Submitted That Met QC Criteria
March 14, 2023
Last Verified
March 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HMRF 03180198
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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