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

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.

Study Overview

• Status: Completed
• Conditions: Mild Cognitive Impairment; Dementia Mild
• Intervention / Treatment: Behavioral: ACP programme "Have a Say"; Behavioral: Attention-control health talks

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.

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Hong Kong
  • Kowloon, Hong Kong
    • Hong Kong Family Welfare Society Kowloon City Centre for Active Ageing
  • Kowloon, Hong Kong
    • Hong Kong Sheng Kung Hui Chuk Yuen Canon Martin District Elderly Community Centre
  • Kowloon, Hong Kong
    • Hong Kong Sheng Kung Hui Lok Man Alice Kwok Integrated Service Centre
  • Kowloon, Hong Kong
    • Yang Memorial Methodist Social Service Choi Hung Community Centre for Senior Citizens
  • Yuen Long, Hong Kong
    • Mrs. Wong Tung Yuen District Elderly Community Centre

Participation Criteria

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:

• 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.

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Attention control; 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.	Behavioral: Attention-control health talks; 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
Experimental: Advance care planning programme; It 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.	Behavioral: ACP programme "Have a Say"; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline, immediately after the intervention, 1 month and 3 months follow up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline, immediately after the intervention, 1 month and 3 months follow up
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.	Baseline, immediately after the intervention, 1 month and 3 months follow up
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.	Baseline, immediately after the intervention, 1 month and 3 months follow up

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subject recruitment rate	The proportion of subjects referred by the centres who were eligible and consented to join the trial	Baseline
Subject attrition rate	The proportion of subjects consented to the trial and dropout	Immediately after the intervention, 1 month and 3 months follow up
Completion rate	The proportion of subjects completed at least 2 sessions of the intervention out of 3.	Immediately after the intervention
Satisfaction score	Participants from the intervention group will be asked to complete a 5-item satisfaction questionnaire to provide ratings on the content, timing, and duration of the intervention; the usefulness of the information provided; and the performance of the ACP facilitators. The items are rated on a 5-point Likert scale (5= totally agree; 1= totally disagree), with a higher total score indicating greater satisfaction with the intervention	Immediately after the intervention

Collaborators and Investigators

• Sponsor: Hong Kong Metropolitan University
• Collaborators: Chinese University of Hong Kong; The British Council in Hong Kong
• Investigators: Principal Investigator: Chi Yan Cheryl Yeung, MN, Chinese University of Hong Kong

Study record dates

Study Major Dates

• Study Start (Actual): September 9, 2019
• Primary Completion (Actual): April 30, 2020
• Study Completion (Actual): April 30, 2020

Study Registration Dates

• First Submitted: August 11, 2020
• First Submitted That Met QC Criteria: August 11, 2020
• First Posted (Actual): August 14, 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: advance care planning
• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Cognition Disorders; Dementia; Cognitive Dysfunction
• Other Study ID Numbers: SIRCP R6303

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