Effects of An ACP Programme for Older People With Early Dementia

Dementia, Mild Clinical Trial

Official title:

Effects of An Advance Care Planning Programme for Persons With Early Dementia And Their Family Caregivers in the Community

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05240664
• Other study ID #: CREC 2019.438
• Status: Completed
• Phase: N/A
• Start date: January 9, 2021
• Est. completion date: August 31, 2021

Study information

• Verified date: March 2023
• Source: Hong Kong Metropolitan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: August 31, 2021
• Est. primary completion date: August 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Dementia
• Dementia, Mild

Intervention

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.
• 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.

Locations

Country	Name	City	State
Hong Kong	HKSKH Lok Man Alice Kwok Integrated Service Centre	Kowloon
Hong Kong	Hong Kong Christian Service	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	Jockey Club Centre for Positive Ageing	Sha Tin
Hong Kong	Yau On Lutheran Centre for the Elderly	Tuen Mun

Sponsors (2)

Lead Sponsor	Collaborator
Hong Kong Metropolitan University	Chinese University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

References & Publications (9)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change in dyadic concordance of preference on end-of-life care	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
Secondary	change in depression	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
Secondary	Change in caregivers' stress	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