- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07448649
Chatbot-Assisted Advance Care Planning Education for Family Members (ChatACP)
Messaging-and-chatbot-assisted Nursing Consultation to Empower Family Members of Residents Living in Nursing Homes on Advance Care Planning (ChatACP)
The goal of this clinical trial is to learn if a messaging and chatbot program, called ChatACP, helps family members of people living in nursing homes take part in advance care planning.
The main questions this study aims to answer are:
- Does ChatACP help family members feel more ready to talk about future medical and personal care with their loved one?
- Does ChatACP help family members take part in advance care planning activities, such as having care discussions or completing planning documents?
- Is ChatACP easy to use and acceptable for family members?
Researchers will compare ChatACP to standard self-learning materials about advance care planning to see which approach works better.
Participants will:
- Receive short daily messages with pictures or videos about advance care planning and access to a chatbot specialized in ACP for 10 days
- Complete surveys at the start of the study, after the program ends, and again 3 months later
- Take part in an interview to share their experience with the program
Study Overview
Status
Conditions
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Tongyao Wang
- Phone Number: 85255968294
- Email: tongyao1@hku.hk
Study Contact Backup
- Name: Qianqian Long
- Phone Number: 85290614121
- Email: yennilon@hku.hk
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- aged 18 years or older
- providing care for an older adult (age 65 or above) living in a care home as a family member (including the family members in the traditional sense and the guardian and persons close to or significant to the older adult)
- able to read, write and communicate in Cantonese or Mandarin
- the resident, care recipient, having a prefrail or frail status as defined by a score of 3 or above on the Clinical Frailty Scale (CFS)
- having a mobile device to receive instant messages and access to cellular network
- engaged in minimal or no prior EOL care discussions with the care home resident as defined by a self-reported status of pre contemplation/contemplation stage on ACP discussions with the resident using the ACP staging algorithm
Exclusion Criteria:
- suffering from moderate to severe cognitive impairment defined by an Abbreviated Mental Test score of 5 or less and unable to give consent
- suffering from communication problems (e.g., deafness or aphasia)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: ChatACP Group
|
The ChatACP for family members encompassed a digital education component and a care provider engagement component.
The digital education component includes 10-day messages of ACP infographics, video clips, and a chatbot with specific content for ACP.
The care provider engagement component includes one nurse-led telephone consultation.
|
|
Active Comparator: Control group (ACP self-learning)
|
Participants in the control group will be provided with self-learning ACP education material created by the Hong Kong Hospital Authority for public education.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Recruitment feasibility
Time Frame: From enrollment to 3-month follow-ups
|
Recruitment rate will be assessed by calculating the percentage of eligible family members who provide study consent and actively participate in the study.
|
From enrollment to 3-month follow-ups
|
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Retention rate
Time Frame: From enrollment to 3-month follow-ups
|
The proportion of participants who successfully complete all surveys and interview for outcome measures and intervention effect outcomes.
|
From enrollment to 3-month follow-ups
|
|
Percentage of Intervention Components Delivered in Compliance with the Intervention Protocol
Time Frame: From enrollment to 3-month follow-ups
|
Fidelity refers to the extent to which core intervention components were delivered as planned by the research team. Delivery indicators include: Provision of assigned infographics Provision of assigned educational videos Respondent to inquiries Completion of scheduled nurse consultation sessions Fidelity will be calculated as: (Number of intervention components delivered as planned ÷ Total planned intervention components) × 100%. Higher percentages indicate greater adherence to the intervention protocol. Progression criterion: The intervention will be considered feasible if ≥90% of core intervention components are delivered in accordance with the protocol. |
From enrollment to 3-month follow-ups
|
|
Participant Engagement Measured by Messaging Platform Interaction Logs and Self-Reported Message Reading Percentage
Time Frame: assessed at post-intervention (T1, immediately after completion of the intervention), based on usage data collected during the intervention period
|
Participant engagement will be assessed using automatically recorded conversation logs from the messaging platform and chatbot system, as well as participant self-reported message reading extent. Engagement indicators include:
Interaction frequency will be reported as counts per participant. Message reading extent will be reported as a percentage (0-100%). Higher interaction frequency and higher reading percentages indicate greater engagement with the intervention. Progression criterion: The intervention will be considered feasible if ≥50% of participants have at least one recorded interaction (via instant message, phone call, or chatbot) and report reading ≥50% of the daily intervention messages. |
assessed at post-intervention (T1, immediately after completion of the intervention), based on usage data collected during the intervention period
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|
Mean Score of the Perceived Infographic Usability Scale (0-100% per Item)
Time Frame: post-intervention (T1, within 1 week after completion of the intervention), and 3 months post-intervention (T2)
|
The scale evaluates message-delivered infographics across eight domains: Trustworthiness Clarity Risk of confusion Difficulty to follow Usefulness Informativeness Comprehensibility Simplicity Each item is rated using a 0-100% sliding scale (0 = lowest perceived usability; 100 = highest perceived usability). For each domain, the mean score will be calculated. Higher scores indicate better perceived usability of the infographic content. Progression criterion: The infographic content will be considered usable if the mean score for each domain is ≥78%. |
post-intervention (T1, within 1 week after completion of the intervention), and 3 months post-intervention (T2)
|
|
Proportion of Participants Reporting High Satisfaction (Score 4-5) on all three items of the Investigator-Developed Acceptability Survey (5-Point Likert Scale)
Time Frame: post-intervention (T1, within 1 week after completion of the intervention), and 3 months post-intervention (T2)
|
Intervention acceptability will be assessed using an investigator-developed satisfaction survey. The survey evaluates three domains:
Each item is rated on a 5-point Likert scale:
Scores range from 1 to 5 for each item. Higher scores indicate greater satisfaction and acceptability. Progression criterion: The intervention will be considered acceptable if ≥70% of participants score 4 or 5 on all three items |
post-intervention (T1, within 1 week after completion of the intervention), and 3 months post-intervention (T2)
|
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Intervention safety
Time Frame: From enrollment to 3-month follow-ups
|
Risk assessment will be conducted using self-reported adverse events.
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From enrollment to 3-month follow-ups
|
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Background questionnaire
Time Frame: at baseline (T0, prior to intervention)
|
The questionnaire includes demographics and care-related information.
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at baseline (T0, prior to intervention)
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Qualitative Findings on Feasibility and Acceptability of the Intervention Based on Semi-Structured Interviews
Time Frame: at 3-month post-intervention follow-up (T2)
|
Semi-structured qualitative interviews will be conducted at 3-month follow-up using an interview guide developed by the Principal Investigator. Interviews aim to explore family caregivers' experiences with the intervention, including perceived acceptability, logistics, and suggestions for improvement. Interviews will be audio-recorded, transcribed verbatim, and analyzed using thematic analysis. Findings will be reported as identified themes and representative quotations. Progression criteria: The intervention will be considered feasible if qualitative findings demonstrate overall positive perceptions regarding acceptability, logistics, and perceived usefulness of the intervention. |
at 3-month post-intervention follow-up (T2)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Chinese Version of the 10-item Family Members' ACP Readiness Questionnaire (Total Score, 10-50)
Time Frame: at baseline (T0, prior to intervention), post-intervention (T1, within 1 week after completion of the intervention), and 3 months post-intervention (T2)
|
The Chinese version of the 10-item Family Members' Advance Care Planning (ACP) Readiness Questionnaire assesses family members' self-reported ACP knowledge, readiness to discuss ACP with a loved one, self-efficacy in initiating ACP conversations, perceived barriers, emotional perceptions and attitudes toward ACP, and perceived communication tools for ACP discussions. Each item is rated on a 5-point Likert scale (1-5). Total scores range from 10 to 50, calculated by summing all items. Higher scores indicate greater ACP readiness. The instrument was developed based on key domains reported in adult ACP readiness measures and constructs identified in a systematic review of family members' roles in ACP. The Chinese version has demonstrated good internal consistency (Cronbach's α = 0.86-0.90). |
at baseline (T0, prior to intervention), post-intervention (T1, within 1 week after completion of the intervention), and 3 months post-intervention (T2)
|
|
Chinese Version of the 17-item Advance Care Planning Engagement Survey for Surrogate Decision Makers (Total Score, 17-85)
Time Frame: at baseline (T0, prior to intervention), post-intervention (T1, within 1 week after completion of the intervention), and 3 months post-intervention (T2)
|
The Chinese version of the 17-item Advance Care Planning Engagement Survey for Surrogate Decision Makers assesses caregivers' engagement in the advance care planning (ACP) process. The instrument comprises 17 items rated on a 5-point Likert scale (1-5). Total scores range from 17 to 85, calculated by summing all items. Higher scores indicate greater engagement in the ACP process. The scale includes three domains: Serving as a surrogate decision maker (7 items), Contemplation (4 items), and Readiness (6 items). The instrument was adapted from the original 55-item ACP Engagement Survey and has been validated among surrogates of patients with chronic illness. The Chinese version has demonstrated high internal consistency (Cronbach's α = 0.90-0.91). |
at baseline (T0, prior to intervention), post-intervention (T1, within 1 week after completion of the intervention), and 3 months post-intervention (T2)
|
|
Number of Participants Reporting Completion of Each of Six Advance Care Planning Activities
Time Frame: at baseline (T0, prior to intervention), post-intervention (T1, within 1 week after completion of the intervention), and 3 months post-intervention (T2)
|
Participants will report a binary response ("Yes" or "No") to six advance care planning (ACP) behaviors widely used to evaluate ACP outcomes:
For each activity, results will be reported as the number and proportion of participants selecting "Yes." A "Yes" response indicates that the specified ACP activity has been completed. A "No" response indicates that the activity has not been completed. |
at baseline (T0, prior to intervention), post-intervention (T1, within 1 week after completion of the intervention), and 3 months post-intervention (T2)
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- UW25-567
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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