Effects of An ACP Programme for Older People With Early Dementia

NCT ID: NCT05240664

Last Updated: 2023-03-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-09

Study Completion Date

2021-08-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Dementia, Mild

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Dyads of participants recruited from all elderly community centres will be randomized at block size equals to 4 in 1:1 ratio into intervention group and control group.
Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Outcome Assessors
Outcome assessors will be blinded to the group assignment and research question.

Study Groups

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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.

Group Type EXPERIMENTAL

Have A Say Programme

Intervention Type BEHAVIORAL

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.

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.

Group Type PLACEBO_COMPARATOR

Attention-control health talks

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chinese University of Hong Kong

OTHER

Sponsor Role collaborator

Hong Kong Metropolitan University

OTHER

Sponsor Role lead

Responsible Party

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Ms Cheryl Yeung Chi Yan

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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HKSKH Lok Man Alice Kwok Integrated Service Centre

Kowloon, , Hong Kong

Site Status

Hong Kong Christian Service

Kowloon, , Hong Kong

Site Status

Hong Kong Sheng Kung Hui Chuk Yuen Canon Martin District Elderly Community Centre

Kowloon, , Hong Kong

Site Status

Yang Memorial Methodist Social Service Choi Hung Community Centre for Senior Citizens

Kowloon, , Hong Kong

Site Status

Jockey Club Centre for Positive Ageing

Shatin, , Hong Kong

Site Status

Yau On Lutheran Centre for the Elderly

Tuenmen, , Hong Kong

Site Status

Countries

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Hong Kong

References

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Sudore RL, Heyland DK, Barnes DE, Howard M, Fassbender K, Robinson CA, Boscardin J, You JJ. Measuring Advance Care Planning: Optimizing the Advance Care Planning Engagement Survey. J Pain Symptom Manage. 2017 Apr;53(4):669-681.e8. doi: 10.1016/j.jpainsymman.2016.10.367. Epub 2016 Dec 29.

Reference Type BACKGROUND
PMID: 28042072 (View on PubMed)

Sudore RL, Lum HD, You JJ, Hanson LC, Meier DE, Pantilat SZ, Matlock DD, Rietjens JAC, Korfage IJ, Ritchie CS, Kutner JS, Teno JM, Thomas J, McMahan RD, Heyland DK. Defining Advance Care Planning for Adults: A Consensus Definition From a Multidisciplinary Delphi Panel. J Pain Symptom Manage. 2017 May;53(5):821-832.e1. doi: 10.1016/j.jpainsymman.2016.12.331. Epub 2017 Jan 3.

Reference Type BACKGROUND
PMID: 28062339 (View on PubMed)

Liu L, Zhao YY, Zhang LH, Chan HY. Measuring Self-Efficacy and Readiness for Advance Care Planning in Chinese Older Adults. J Pain Symptom Manage. 2020 Sep;60(3):622-629. doi: 10.1016/j.jpainsymman.2020.06.013. Epub 2020 Jun 20.

Reference Type BACKGROUND
PMID: 32574659 (View on PubMed)

Ditto PH, Danks JH, Smucker WD, Bookwala J, Coppola KM, Dresser R, Fagerlin A, Gready RM, Houts RM, Lockhart LK, Zyzanski S. Advance directives as acts of communication: a randomized controlled trial. Arch Intern Med. 2001 Feb 12;161(3):421-30. doi: 10.1001/archinte.161.3.421.

Reference Type BACKGROUND
PMID: 11176768 (View on PubMed)

Chan HY, Ng JS, Chan KS, Ko PS, Leung DY, Chan CW, Chan LN, Lee IF, Lee DT. Effects of a nurse-led post-discharge advance care planning programme for community-dwelling patients nearing the end of life and their family members: A randomised controlled trial. Int J Nurs Stud. 2018 Nov;87:26-33. doi: 10.1016/j.ijnurstu.2018.07.008. Epub 2018 Jul 23.

Reference Type BACKGROUND
PMID: 30048916 (View on PubMed)

Alexopoulos GS, Abrams RC, Young RC, Shamoian CA. Cornell Scale for Depression in Dementia. Biol Psychiatry. 1988 Feb 1;23(3):271-84. doi: 10.1016/0006-3223(88)90038-8.

Reference Type BACKGROUND
PMID: 3337862 (View on PubMed)

Lin JN, Wang JJ. Psychometric evaluation of the Chinese version of the Cornell Scale for Depression in Dementia. J Nurs Res. 2008 Sep;16(3):202-10. doi: 10.1097/01.jnr.0000387307.34741.39.

Reference Type BACKGROUND
PMID: 18792890 (View on PubMed)

Zarit SH, Reever KE, Bach-Peterson J. Relatives of the impaired elderly: correlates of feelings of burden. Gerontologist. 1980 Dec;20(6):649-55. doi: 10.1093/geront/20.6.649. No abstract available.

Reference Type BACKGROUND
PMID: 7203086 (View on PubMed)

Tang JY, Ho AH, Luo H, Wong GH, Lau BH, Lum TY, Cheung KS. Validating a Cantonese short version of the Zarit Burden Interview (CZBI-Short) for dementia caregivers. Aging Ment Health. 2016 Sep;20(9):996-1001. doi: 10.1080/13607863.2015.1047323. Epub 2015 May 27.

Reference Type BACKGROUND
PMID: 26016419 (View on PubMed)

Other Identifiers

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CREC 2019.438

Identifier Type: -

Identifier Source: org_study_id

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