Promoting ACP in Persons With MCI and Early Stage Dementia and Their Family Caregivers in Community Care Setting: a Feasibility RCT

• ClinicalTrials.gov Identifier: NCT04513106
• Recruitment Status: Completed
• First Posted: August 14, 2020
• Last Update Posted: January 20, 2022
• Sponsor: Hong Kong Metropolitan University
• Collaborators: Chinese University of Hong Kong; The British Council in Hong Kong
• Information provided by (Responsible Party): Ms Cheryl Yeung Chi Yan, Hong Kong Metropolitan University

Study Description

Brief Summary:

Advance care planning (ACP) has been widely advocated to persons with early stage dementia (PWEDs) and persons with mild cognitive impairment (MCI). This feasibility randomised controlled trial (RCT) 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.

Condition or disease	Intervention/treatment	Phase
Dementia Mild; Mild Cognitive Impairment	Behavioral: ACP programme "Have a Say"; Behavioral: Attention-control health talks	Not Applicable

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) or mild cognitive impairment and their family caregivers in the community. A multi-centre, single-blind, two-arm randomizsed controlled trial 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 randomly assigned to intervention group and control group. 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.

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 36 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Participated elderly community centres will be randomized at center level into intervention group and control group in 1:1 ratio.
• Masking: Single (Outcomes Assessor)
• Masking Description: Outcome assessors will be blinded to group assignment of participants, and the research question.
• Primary Purpose: Health Services Research
• Official Title: Promoting Advance Care Planning in Persons With Mild Cognitive Impairment and Early Stage Dementia and Their Family Caregivers in Community Care Setting: a Feasibility Randomised Controlled Trial
• Actual Study Start Date: September 9, 2019
• Actual Primary Completion Date: April 30, 2020
• Actual Study Completion Date: April 30, 2020

Arms and Interventions

Arm	Intervention/treatment
Experimental: Advance care planning programme; 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.	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.
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

Outcome Measures

Primary Outcome Measures :

1. Change in advance care planning engagement [ Time Frame: Baseline, immediately after the intervention, 1 month and 3 months 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 Outcome Measures :

1. Change in dyadic concordance of end-of-life care preferences [ Time Frame: Baseline, immediately after the intervention, 1 month and 3 months follow up ]
   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.

Other Outcome Measures:

1. Depression [ Time Frame: Baseline, immediately after the intervention, 1 month and 3 months follow up ]
   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.
2. Caregivers' stress [ Time Frame: Baseline, immediately after the intervention, 1 month and 3 months follow up ]
   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.

Eligibility Criteria

• Ages Eligible for Study: 55 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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.

Contacts and Locations

Locations

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

Kowloon, Hong Kong

Mrs. Wong Tung Yuen District Elderly Community Centre

Yuen Long, Hong Kong

Sponsors and Collaborators

Hong Kong Metropolitan University

Chinese University of Hong Kong

The British Council in Hong Kong

Investigators

• Principal Investigator: Chi Yan Cheryl Yeung, MN; Hong Kong Metropolitan University

More Information

• Responsible Party: Ms Cheryl Yeung Chi Yan, Senior Lecturer, Hong Kong Metropolitan University
• ClinicalTrials.gov Identifier: NCT04513106
• Other Study ID Numbers: SIRCP R6303
• First Posted: August 14, 2020
• Last Update Posted: January 20, 2022
• Last Verified: January 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Ms Cheryl Yeung Chi Yan, Hong Kong Metropolitan University:

advance care planning

Additional relevant MeSH terms:

Dementia; Cognitive Dysfunction; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders; Cognition Disorders