Advance Care PlanningNCT04203407
Effects of a Culturally-sensitive Theory-driven Advance Care Planning (ACP) Game Among Chinese Older Adults
A study testing ACP game in people with Advance Care Planning and Game, run by Chinese University of Hong Kong at 1 site in China.
Trial summary
This proposed study aims to examine the effects of a culturally-sensitive theory-driven advance care planning (ACP) game in increasing the self-efficacy and readiness of ACP behaviours among Chinese community-dwelling older adults. Read more about this study
- Who is it for?
- Ages 60 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Advance Care Planning, Game, Older Adults
- What is being tested?
- ACP game
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- 1 siteChina
- Study dates
- 8 Aug 2020to 25 Dec 2020
- 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 60 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- aged 60 years or over;
- speak Chinese.
Who cannot join
- uncommunicable because of language barrier or sensory impairment;
- have been referred to the palliative care service at the time of recruitment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of a Culturally-sensitive Theory-driven Advance Care Planning (ACP) Game on Self-efficacy and ACP Behaviors Among Chinese Older Adults: a Mixed Method Study
This proposed study aims to examine the effects of a culturally-sensitive theory-driven advance care planning (ACP) game in increasing the self-efficacy and readiness of ACP behaviours among Chinese community-dwelling older adults. This is a mixed methods study with the quantitative paradigm being the main research approached used. The quantitative arm will be a randomized controlled trial (RCT). The qualitative arm will adopt focus group interviews for data collection. Recruited subjects from the community centres will be randomly allocated to the intervention and control group. The older adults in the experimental group will receive an ACP board game delivered by trained facilitators, whereas the older adults in the control group will receive another board game about healthy lifestyle. The outcome measures of the older adults will include the ACP Engagement scale, the Life-Support Preferences Questionnaire (LSPQ), a self-developed ACP knowledge questionnaire and those data will be collected at baseline (T0), immediately post-intervention(T1), at 1 month (T2), and 3 month (T3). The qualitative arm of this study will contribute to the understanding of issues and effects of ACP game as an intervention. Its finding will complement the results obtained from the RCT.
- Conditions
- Advance Care Planning, Game, Older Adults
- Being tested
- ACP game, Usual care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACP gameBehavioural
Participants in the intervention group will be divided into groups of 4 participants to play a 1-hour culturally-sensitive theory-driven ACP board game with 15-minute debriefing delivered by facilitators. The ACP board game is developed by the principle investigator in a previous project.
Usual careBehavioural
Participants in the control group will receive a 1-hour board game about health lifestyle.
| Study group | Role | What they receive |
|---|---|---|
| ACP game | Experimental | Participants in the intervention group will be divided into groups of 4 participants to play a 1-hour culturally-sensitive theory-driven ACP board game with 15-minute debriefing delivered by facilitators. The ACP board game is developed by the principle investigator in a previous project. Receives: Behavioral: ACP game |
| Usual care | Active comparator | Participants in the control group will receive a 1-hour board game about health lifestyle. Receives: Behavioral: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Advance Care Planning Engagement Scale
Behaviour changes in ACP behaviours measured using Advance Care Planning Engagement Scale. It is about different ACP behavior on a 5-point Likert scale. The higher score means the higher level of self-efficacy and readiness for the behaviours.
Measured: 3 months
Secondary outcomes (2)
Certainty rate of end-of-life preferences toward medical care
End-of-life preferences is measured by the Life-Support Preferences Questionnaire (LSPQ). It describes one hypothetical terminally ill scenario. 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) , will be asked.
Measured: 3 months
Self-develped ACP knowledge questionnaire
The questionnaire comprised 10 questions. Response options for each of these questions were "yes" and "no". Content validity was assessed within a palliative care expert team.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2019
- Study start8 Aug 2020
- Primary completion25 Dec 2020
- Study completion25 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Advance Care PlanningStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 144 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Collaborators
- Xihu community healthcare service centre, Guanshaling community healthcare service centre
- Responsible party
- Principal investigator, LIU Li, Chinese University of Hong Kong
- Investigators
- Li LIU, Principal investigator, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04203407
- Sponsor's protocol ID
- CREC2019428
- Other IDs
- ChiCTR1900028190
- Status last verified
- Jan 2021
- First submitted
- 15 Dec 2019
- Last updated
- 27 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Liu L, Chan HY, Zhao YY, Xiong GJ, Qing MB, Gu C, Wang Y. Effects of a Game on Advance Care Planning Engagement in Older Adults: A Randomized Controlled Trial. J Pain Symptom Manage. 2025 May;69(5):536-545.e9. doi: 10.1016/j.jpainsymman.2025.02.016. Epub 2025 Feb 21.
PubMed 39988017
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Culturally-sensitive Theory-driven Advance Care Planning (ACP) Game on Self-efficacy and ACP Behaviors Among Chinese Older Adults: a Mixed Method Study
- ClinicalTrials.gov ID
- NCT04203407
- Acronym / sponsor ID
- CREC2019428
- Conditions
- Advance Care Planning, Game, Older Adults
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 144 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Collaborators
- Xihu community healthcare service centre, Guanshaling community healthcare service centre
- Study start
- 8 Aug 2020 (actual)
- Primary completion
- 25 Dec 2020 (actual)
- Study completion
- 25 Dec 2020 (actual)
- First posted
- 18 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This proposed study aims to examine the effects of a culturally-sensitive theory-driven advance care planning (ACP) game in increasing the self-efficacy and readiness of ACP behaviours among Chinese community-dwelling older adults. This is a mixed methods study with the quantitative paradigm being the main research approached used. The quantitative arm will be a randomized controlled trial (RCT). The qualitative arm will adopt focus group interviews for data collection. Recruited subjects from the community centres will be randomly allocated to the intervention and control group. The older adults in the experimental group will receive an ACP board game delivered by trained facilitators, whereas the older adults in the control group will receive another board game about healthy lifestyle. The outcome measures of the older adults will include the ACP Engagement scale, the Life-Support Preferences Questionnaire (LSPQ), a self-developed ACP knowledge questionnaire and those data will be collected at baseline (T0), immediately post-intervention(T1), at 1 month (T2), and 3 month (T3). The qualitative arm of this study will contribute to the understanding of issues and effects of ACP game as an intervention. Its finding will complement the results obtained from the RCT.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ACP game | Experimental | Behavioral: ACP gameParticipants in the intervention group will be divided into groups of 4 participants to play a 1-hour culturally-sensitive theory-driven ACP board game with 15-minute debriefing delivered by facilitators. The ACP board game is developed by the principle investigator in a previous project. |
| Usual care | Active comparator | Behavioral: Usual careParticipants in the control group will receive a 1-hour board game about health lifestyle. |
Who may qualify
- Ages
- 60 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- aged 60 years or over;
- speak Chinese.
Key exclusion criteria (2 listed)
- uncommunicable because of language barrier or sensory impairment;
- have been referred to the palliative care service at the time of recruitment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ACP gameParticipants in the intervention group will be divided into groups of 4 participants to play a 1-hour culturally-sensitive theory-driven ACP board game with 15-minute debriefing delivered by facilitators. The ACP board game is developed by the principle investigator in a previous project. | Behavioural | ACP game |
| Usual careParticipants in the control group will receive a 1-hour board game about health lifestyle. | Behavioural | Usual care |
Primary outcome
Advance Care Planning Engagement Scale
Time frame: 3 months
Behaviour changes in ACP behaviours measured using Advance Care Planning Engagement Scale. It is about different ACP behavior on a 5-point Likert scale. The higher score means the higher level of self-efficacy and readiness for the behaviours.
2 secondary outcomes
Certainty rate of end-of-life preferences toward medical care
Time frame: 3 months
Self-develped ACP knowledge questionnaire
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2021.
- Derived from this study: PubMed 39988017Liu L, Chan HY, Zhao YY, Xiong GJ, Qing MB, Gu C, Wang Y. Effects of a Game on Advance Care Planning Engagement in Older Adults: A Randomized Controlled Trial. J Pain Symptom Manage. 2025 May;69(5):536-545.e9. doi: 10.1016/j.jpainsymman.2025.02.016. Epub 2025 Feb 21.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Li LIU principal investigator
Chinese University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ACP game in people with Advance Care Planning and Game, run by Chinese University of Hong Kong at 1 site in China.
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 2 inclusion and 2 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 27 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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. 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?
Advance Care Planning Engagement Scale (time frame: 3 months). 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 NCT04203407, which also lists 1 linked publication.
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 27 Jan 2021.