Old AgeNCT06296719
The Chit-Chat Educational Intervention to Promote Advance Care Planning in the Community
A study testing Chit-Chat in people with Old Age and Family Members, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
Trial summary
The purpose of this study is to estimate the effect size of the Chit-Chat intervention on ACP engagement among family members of older adults with multi-morbidity. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Old Age, Family Members
- What is being tested?
- Chit-Chat
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteHong Kong
- Study dates
- 30 May 2024to 31 Aug 2024
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- age 18 or above;
- a family member of a relative who aged 60 or above and lives with at least two severe chronic diseases such as cancer, dementia, lung, heart, liver, and renal disease.
- they perceived themselves will take part in taking care of their relatives in the near future;
- able to read and communicate in Cantonese.
- they are self-reported as cognitively intact
Who cannot join
- their relatives have been referred to palliative care service before the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Empowering Family Members of Older Adults with Multi-morbidity in Advance Care Planning Conversations: Development and Feasibility Testing of the Chit-Chat Educational Intervention
The purpose of this study is to estimate the effect size of the Chit-Chat intervention on ACP engagement among family members of older adults with multi-morbidity.
Read the detailed description
After being informed about the study and potential risks, all eligible participants will be asked to provide written informed consent for study entry. At week 0, participants will be randomized in an assessor-blinded randomized controlled trial in a 1:1 ratio to received the Chit-Chat intervention (two 2-hr weekly educational sessions) or wait-list control group.
- Conditions
- Old Age, Family Members
- Being tested
- Chit-Chat
- Keywords
- Family members, Older Adults with multi-morbidity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chit-ChatOther
Participants will receive the 2 sessions of the Chit-Chat intervention on a weekly basis.
| Study group | Role | What they receive |
|---|---|---|
| Chit-Chat | Experimental | The Chit-Chat intervention, covering five areas, including (1) Serious illness in older adults, (2) Realities of caring and dying from a carer's perspective, (3) Introduction to the importance of advance care planning for individuals and communities, (4) Effective communication between older adults, family members, and healthcare professionals in ACP conversations (i.e. listening to the wishes and preferences of older adults regarding their needs), and (5) audience participation and clarification including questions, answers and concerns. Receives: Other: Chit-Chat |
| Waitlist Control | No intervention | No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
ACP engagement
The validated Chinese version of the ACP Engagement Survey - Surrogate Decision Maker consists of 17 items covering 4 dimensions: role cognition, contemplation, self-efficacy, and readiness. The questionnaire used a 5-point Likert scale to gather response. The total score can range between 17 and 85, with higher score indicating higher level of ACP engagement.
Measured: 2 Weeks; 1-month follow-up
Secondary outcomes (1)
Knowledge of ACP
The Knowledge Questionnaire consists of five items which address the purposes of ADs, EOL discussion, and issues related to ACP. The possible range of the total score is 0-5, with higher scores indicating better knowledge.
Measured: 2 Weeks; 1-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2024
- Study start30 May 2024
- Primary completion31 Aug 2024
- Study completion31 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Old AgeStudies of the same condition, open and under way.
- More trials run by The Hong Kong Polytechnic UniversityThe 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Doris YP Leung, PhD, Principal investigator, The Hong Kong Polytechnic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06296719
- Sponsor's protocol ID
- ACP Community 2024
- Status last verified
- Feb 2024
- First submitted
- 27 Feb 2024
- Last updated
- 10 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data are not readily shared because permission to use the data by other researchers has to seek approval from the ethical committee. Request to access IPD should be directed to PI for further consideration and seeking approval from ethical committee.
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Empowering Family Members of Older Adults with Multi-morbidity in Advance Care Planning Conversations: Development and Feasibility Testing of the Chit-Chat Educational Intervention
- ClinicalTrials.gov ID
- NCT06296719
- Acronym / sponsor ID
- ACP Community 2024
- Conditions
- Old Age, Family Members
- Keywords
- Family members, Older Adults with multi-morbidity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Study start
- 30 May 2024 (actual)
- Primary completion
- 31 Aug 2024 (actual)
- Study completion
- 31 Aug 2024 (actual)
- First posted
- 6 Mar 2024 (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.
The purpose of this study is to estimate the effect size of the Chit-Chat intervention on ACP engagement among family members of older adults with multi-morbidity.
Detailed description
After being informed about the study and potential risks, all eligible participants will be asked to provide written informed consent for study entry. At week 0, participants will be randomized in an assessor-blinded randomized controlled trial in a 1:1 ratio to received the Chit-Chat intervention (two 2-hr weekly educational sessions) or wait-list control group.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chit-Chat | Experimental | Other: Chit-ChatThe Chit-Chat intervention, covering five areas, including (1) Serious illness in older adults, (2) Realities of caring and dying from a carer's perspective, (3) Introduction to the importance of advance care planning for individuals and communities, (4) Effective communication between older adults, family members, and healthcare professionals in ACP conversations (i.e. listening to the wishes and preferences of older adults regarding their needs), and (5) audience participation and clarification including questions, answers and concerns. |
| Waitlist Control | No intervention | –No intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- age 18 or above;
- a family member of a relative who aged 60 or above and lives with at least two severe chronic diseases such as cancer, dementia, lung, heart, liver, and renal disease.
- they perceived themselves will take part in taking care of their relatives in the near future;
- able to read and communicate in Cantonese.
- they are self-reported as cognitively intact
Key exclusion criteria (1 listed)
- their relatives have been referred to palliative care service before the study.
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 |
|---|---|---|
| Chit-ChatParticipants will receive the 2 sessions of the Chit-Chat intervention on a weekly basis. | Other | Chit-Chat |
Primary outcome
ACP engagement
Time frame: 2 Weeks; 1-month follow-up
The validated Chinese version of the ACP Engagement Survey - Surrogate Decision Maker consists of 17 items covering 4 dimensions: role cognition, contemplation, self-efficacy, and readiness. The questionnaire used a 5-point Likert scale to gather response. The total score can range between 17 and 85, with higher score indicating higher level of ACP engagement.
1 secondary outcome
Knowledge of ACP
Time frame: 2 Weeks; 1-month follow-up
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 10 Oct 2024.
- Individual participant dataSharing planned: No. Individual participant data are not readily shared because permission to use the data by other researchers has to seek approval from the ethical committee. Request to access IPD should be directed to PI for further consideration and seeking approval from ethical committee.
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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.
Doris YP Leung, PhD principal investigator
The Hong Kong Polytechnic University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chit-Chat in people with Old Age and Family Members, run by The Hong Kong Polytechnic University at 1 site 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 5 inclusion and 1 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 10 Oct 2024. 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 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. 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?
ACP engagement (time frame: 2 Weeks; 1-month follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Oct 2024.