Effects of An ACP Programme for Older People With Early Dementia

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 Dementia And Their Family Caregivers in the Community

Advance care planning (ACP) has been widely advocated for persons with early stage dementia (PWEDs). 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 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

Intervention / Treatment

Detailed Description

This study aims to evaluate the 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 randomized controlled trial with repeated blinded outcome assessment will be conducted to assess the effects of an ACP programme on dyads of PWEDs 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 have a Global Deterioration Score (GDS) 3 or 4 will be eligible to this study. Participants in the experimental group 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. Individuals assigned to the control group will receive attention-control health talks. 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)

60

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

  • Hong Kong
      • Kowloon, Hong Kong
        • Hong Kong Sheng Kung Hui Chuk Yuen Canon Martin District Elderly Community Centre
      • Kowloon, Hong Kong
        • Yang Memorial Methodist Social Service Choi Hung Community Centre for Senior Citizens
      • Kowloon, Hong Kong
        • HKSKH Lok Man Alice Kwok Integrated Service Centre
      • Kowloon, Hong Kong
        • Hong Kong Christian Service
      • Sha Tin, Hong Kong
        • Jockey Club Centre for Positive Ageing
      • Tuen Mun, Hong Kong
        • Yau On Lutheran Centre for the Elderly

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:

  • being Chinese,
  • being a Cantonese speaker,
  • having a formal diagnosis of any form of dementia at the early stage, or having a Global Deterioration Scale score 3-4,
  • having a designated family caregiver in direct contact and 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.

A family caregiver involved in primary responsibility for caring and care-related decisions for the PWED will also be recruited. Paid caregivers are to be excluded.

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Attention-control health talks
Dyads of participants in the control group will receive health talks. 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 4-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, and healthy diet.
Experimental: ACP intervention
It is a theory-driven ACP programme specifically designed for PWEDs and their family caregivers. The intervention is underpinned by the Bandura's self-efficacy model.
Behavioral: Have A Say Programme
Each dyad of participants will receive a 4-session ACP programme, which consists of 2 group-based sessions and 2 dyadic sessions, one hour for each session. The group-based sessions are led by nurse which include didactic educational components, guided reflection, videos, and group sharing. Dyads of participants will be provided with information about ACP, 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 facilitated by trained ACP facilitators and guided by an ACP booklet. Dyads of participants will be supported to have an individualized ACP discussion guided by an ACP booklet. By the end of the programme, each dyad of participants 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
Time Frame: Outcome will be measured at baseline, immediately after intervention, and 1-month after
The validated 9-item Advance Care Planning (ACP) Engagement Survey will be used to measure the engagement of PWED in the ACP process. Each item is measured on a five-point Likert scale and average 5-point scores will be calculated. It is originated from a longer version of 82 items measuring factors affecting the process of ACP engagement, including knowledge, contemplation, self-efficacy, and readiness. This shorter version reported sound psychometric properties and able to detect change across a broad range of ACP behaviours and ACP domains, with Cronbach's alpha =0.84, cross-sectional correlations =0.85, and delta correlations =0.68. The Chinese version of the ACP Engagement Survey is validated and reported sound psychometrical properties. This scale is composed of self-efficacy subscale and readiness subscale. Higher score reflects a higher level of ACP engagement.
Outcome will be measured at baseline, immediately after intervention, and 1-month after

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in dyadic concordance of preference on end-of-life care
Time Frame: Outcome will be measured at baseline, immediately after intervention, and 1-month after
The Life-Support Preferences Questionnaire will be used to measure the congruence on end-of-life care preferences between each participant dyad. This questionnaire has been modified and validated in the local context. The modified Chinese version of the Life Support Preferences Questionnaire was simplified to assess preferences regarding (i) three kinds of life-sustaining treatments (cardiopulmonary resuscitation, mechanical ventilator and tube feeding) based on three options (want to attempt, refuse or uncertain) and (ii) care goals (comfort-oriented, prolongation of life at all costs or uncertain) regarding a hypothetical end-of-life scenario (terminally ill). This scenario is based on the local advance directive form. Each member of the participated dyad will complete this questionnaire individually simultaneously. Higher score reflects a higher level of dyadic concordance.
Outcome will be measured at baseline, immediately after intervention, and 1-month after
change in depression
Time Frame: Outcome will be measured at baseline, immediately after intervention, and 1-month after
The Cornell Scale for Depression in Dementia will be used to measure the signs and symptoms of depression of PWEDs. It is a validated instrument for various severity levels of dementia patients. This is a 19-item instrument that uses information from interviews with family caregivers. The Chinese version of this instrument reported an expert content validity index as 0.92, and its concurrent validity with the Geriatric Depression Scale short form is 0.322 (p<0.001). Its Cronbach's alpha for internal consistency reliability is 0.84. Higher score reflects a higher level of depression.
Outcome will be measured at baseline, immediately after intervention, and 1-month after
Change in caregivers' stress
Time Frame: Outcome will be measured at baseline, immediately after intervention, and 1-month after
The Zarit Caregiver Burden Interview (ZBI) will be used to measure the caregivers' stress. It has 12 items. The Cantonese short version of this instrument reported sound psychometric properties. Higher score reflects a higher level of caregivers' stress.
Outcome will be measured at baseline, immediately after intervention, and 1-month after

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hong Kong Metropolitan University

Collaborators

Chinese University of Hong Kong

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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, 2021

Study Completion (Actual)

August 31, 2021

Study Registration Dates

First Submitted

January 19, 2022

First Submitted That Met QC Criteria

February 4, 2022

First Posted (Actual)

February 15, 2022

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

  • CREC 2019.438

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.

Clinical Trials on Dementia, Mild

Clinical Trials on Have A Say Programme

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Iran

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe