- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06296719
The Chit-Chat Educational Intervention to Promote Advance Care Planning in the Community
October 8, 2024 updated by: The Hong Kong Polytechnic University
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.
Study Overview
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 Type
Interventional
Enrollment (Actual)
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Hong Kong, Hong Kong
- Hong Kong Polytechnic University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- their relatives have been referred to palliative care service before the study.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Chit-Chat
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.
|
Participants will receive the 2 sessions of the Chit-Chat intervention on a weekly basis.
|
|
No Intervention: Waitlist Control
No intervention
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
2 Weeks; 1-month follow-up
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Knowledge of ACP
Time Frame: 2 Weeks; 1-month follow-up
|
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.
|
2 Weeks; 1-month follow-up
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Doris YP Leung, PhD, The Hong Kong Polytechnic University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 30, 2024
Primary Completion (Actual)
August 31, 2024
Study Completion (Actual)
August 31, 2024
Study Registration Dates
First Submitted
February 27, 2024
First Submitted That Met QC Criteria
March 4, 2024
First Posted (Actual)
March 6, 2024
Study Record Updates
Last Update Posted (Actual)
October 10, 2024
Last Update Submitted That Met QC Criteria
October 8, 2024
Last Verified
February 1, 2024
More Information
Terms related to this study
Other Study ID Numbers
- ACP Community 2024
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
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.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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