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Dementia, MildNCT05240664

Effects of An ACP Programme for Older People With Early Dementia

A study testing Have A Say Programme in people with Dementia, Mild, run by Hong Kong Metropolitan University at 6 sites in Hong Kong.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 55 years and older
Conditions the study is for
Dementia, Mild
What is being tested?
Have A Say Programme
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
60 participants
Where
6 sitesHong Kong
Study dates
9 Jan 2021to 31 Aug 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 55 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

Hong Kong6 sites

  • HKSKH Lok Man Alice Kwok Integrated Service Centre

    Kowloon

  • Hong Kong Christian Service

    Kowloon

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

    Kowloon

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

    Kowloon

  • Jockey Club Centre for Positive Ageing

    Shatin

  • Yau On Lutheran Centre for the Elderly

    Tuenmen

Other trials in Hong Kong

About this study

Official title: 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.

Read the 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.

Conditions
Dementia, Mild
Being tested
Have A Say Programme, Attention-control health talks
Keywords
advance care planning
Medical subject headings
Dementia, Lymphoma, Follicular

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Have A Say ProgrammeBehavioural

    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 talksBehavioural

    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.

Study groups in NCT05240664
Study groupRoleWhat they receive
ACP interventionExperimentalIt 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.
Receives: Behavioral: Have A Say Programme
Attention-control health talksPlacebo comparatorDyads 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.
Receives: Behavioral: Attention-control health talks

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Secondary outcomes (3)

  1. 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.

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

  2. 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.

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

  3. 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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Feb 2022
  2. Study start9 Jan 2021
  3. Primary completion31 Aug 2021
  4. Study completion31 Aug 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Model description
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.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05240664
Sponsor's protocol ID
CREC 2019.438
Status last verified
Mar 2023
First submitted
19 Jan 2022
Last updated
16 Mar 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 28042072

  • 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.

    PubMed 28062339

  • 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.

    PubMed 32574659

  • 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.

    PubMed 11176768

  • 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.

    PubMed 30048916

  • 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.

    PubMed 3337862

  • 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.

    PubMed 18792890

  • 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.

    PubMed 7203086

  • 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.

    PubMed 26016419

Questions about this trial

What is this clinical trial studying?

A study testing Have A Say Programme in people with Dementia, Mild, run by Hong Kong Metropolitan University at 6 sites in Hong Kong.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in advance care planning engagement (time frame: Outcome will be measured at baseline, immediately after intervention, and 1-month after). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05240664, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2023.

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