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NCT Number: NCT04491578

An Advance Care Planning Programme for Persons With Early Stage Dementia in the Community

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.

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Key information

Conditions

Dementia Mild Cognition Disorders Cognitive Dysfunction Mental Disorders Mild Cognitive Impairment Neurocognitive Disorders

Age range

55 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

HKSKH Lok Man Alice Kwok Integrated Service Centre, Kowloon, Hong Kong

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ACP programme "Have a Say"

Behavioral

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.

Primary outcomes

  1. 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

  1. Change in dyadic concordance of end-of-life care preferences

    Time frame: Baseline, immediately after the intervention, 1 month 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 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.

Other outcomes

  1. Depression

    Time frame: Baseline, immediately after the intervention, 1 month follow up

    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.

  2. Caregivers' stress

    Time frame: Baseline, immediately after the intervention, 1 month 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.

Sponsors and collaborators

Lead sponsor

Hong Kong Metropolitan University

Other

Collaborators

  • Chinese University of Hong Kong
  • Food and Health Bureau, Hong Kong

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jul 29, 2020
Registry last updated
Mar 16, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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