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Clinical Trials/NCT04491578
NCT04491578
Completed
Not Applicable

Effects of an Advance Care Planning Programme for Persons With Early Stage Dementia in the Community: A Quasi-experimental Study

Hong Kong Metropolitan University10 sites in 1 country100 target enrollmentJanuary 9, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Dementia Mild
Sponsor
Hong Kong Metropolitan University
Enrollment
100
Locations
10
Primary Endpoint
Change in advance care planning engagement
Status
Completed
Last Updated
3 years ago

Overview

Brief 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 "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.

Registry
clinicaltrials.gov
Start Date
January 9, 2021
End Date
October 31, 2022
Last Updated
3 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Ms Cheryl Yeung Chi Yan

Senior Lecturer

Hong Kong Metropolitan University

Eligibility Criteria

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.

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • Change in dyadic concordance of end-of-life care preferences(Baseline, immediately after the intervention, 1 month follow up)

Study Sites (10)

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