Effects of An ACP Programme for Older People With Early Dementia

NCT05240664 | Completed

• 1 other identifier: CREC 2019.438
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 6

Brief Summary

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.

Conditions

Dementia, Mild

Keywords

advance care planning

Outcome Measures

Primary Outcomes (1)

• Change in advance care planning engagement

  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 Outcomes (3)

• Change in dyadic concordance of preference on end-of-life care

  Outcome will be measured at baseline, immediately after intervention, and 1-month after

• change in depression

  Outcome will be measured at baseline, immediately after intervention, and 1-month after

• Change in caregivers' stress

  Outcome will be measured at baseline, immediately after intervention, and 1-month after

Study Arms (2)

ACP intervention

EXPERIMENTAL

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

Attention-control health talks

PLACEBO COMPARATOR

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

Interventions

Have A Say Programme 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.

ACP intervention

Attention-control health talks 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.

Attention-control health talks

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hong Kong Metropolitan University: lead
• Chinese University of Hong Kong: collaborator

Study Sites (6)

HKSKH Lok Man Alice Kwok Integrated Service Centre

Kowloon, Hong Kong

Location

Hong Kong Christian Service

Kowloon, Hong Kong

Location

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

Kowloon, Hong Kong

Location

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

Kowloon, Hong Kong

Location

Jockey Club Centre for Positive Ageing

Shatin, Hong Kong

Location

Yau On Lutheran Centre for the Elderly

Tuenmen, Hong Kong

Location

Related Publications (9)

• 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.

  PMID: 28042072 BACKGROUND

• 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.

  PMID: 28062339 BACKGROUND

• 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.

  PMID: 32574659 BACKGROUND

• 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.

  PMID: 11176768 BACKGROUND

• 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.

  PMID: 30048916 BACKGROUND

• 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.

  PMID: 3337862 BACKGROUND

• 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.

  PMID: 18792890 BACKGROUND

• 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.

  PMID: 7203086 BACKGROUND

• 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.

  PMID: 26016419 BACKGROUND

MeSH Terms

Conditions

Dementia; Lymphoma, Follicular

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome assessors will be blinded to the group assignment and research question.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: January 19, 2022
• First Posted: February 15, 2022
• Study Start: January 9, 2021
• Primary Completion: August 31, 2021
• Study Completion: August 31, 2021
• Last Updated: March 16, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

HK (6)