NCT07448649

Brief Summary

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

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
24mo left

Started Jun 2026

Typical duration for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 8, 2026

Completed
24 days until next milestone

First Posted

Study publicly available on registry

March 4, 2026

Completed
4 months until next milestone

Study Start

First participant enrolled

June 30, 2026

Expected
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2028

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2028

Last Updated

March 4, 2026

Status Verified

February 1, 2026

Enrollment Period

2 years

First QC Date

February 8, 2026

Last Update Submit

February 26, 2026

Conditions

Outcome Measures

Primary Outcomes (9)

  • Recruitment feasibility

    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

  • Retention rate

    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

    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

    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: 1. Number of interactions (instant messages, phone calls, or chatbot) recorded in the messaging platform and chatbot logs; 2. Self-reported percentage of daily intervention messages read (0% = did not read any messages; 100% = read all assigned messages). 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

  • Mean Score of the Perceived Infographic Usability Scale (0-100% per Item)

    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)

    Intervention acceptability will be assessed using an investigator-developed satisfaction survey. The survey evaluates three domains: 1. Form of delivery 2. Availability of customized support for advance care planning (ACP) questions 3. Degree to which the intervention met participants' needs Each item is rated on a 5-point Likert scale: 1. = Highly dissatisfied 2. = Dissatisfied 3. = Neither satisfied nor dissatisfied 4. = Satisfied 5. = Highly satisfied 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)

  • Intervention safety

    Risk assessment will be conducted using self-reported adverse events.

    From enrollment to 3-month follow-ups

  • Background questionnaire

    The questionnaire includes demographics and care-related information.

    at baseline (T0, prior to intervention)

  • Qualitative Findings on Feasibility and Acceptability of the Intervention Based on Semi-Structured Interviews

    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 Outcomes (3)

  • Chinese Version of the 10-item Family Members' ACP Readiness Questionnaire (Total Score, 10-50)

    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)

    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

    at baseline (T0, prior to intervention), post-intervention (T1, within 1 week after completion of the intervention), and 3 months post-intervention (T2)

Study Arms (2)

ChatACP Group

EXPERIMENTAL
Behavioral: ChatACP - Messaging- and-Chatbot Assisted Nursing Consultation

Control group (ACP self-learning)

ACTIVE COMPARATOR
Behavioral: ACP self- learning handout (Hong Kong Hospital Authority ACP education material)

Interventions

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.

ChatACP Group

Participants in the control group will be provided with self-learning ACP education material created by the Hong Kong Hospital Authority for public education.

Control group (ACP self-learning)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Central Study Contacts

Tongyao Wang

CONTACT

Qianqian Long

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
data analyst
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assitant Professor

Study Record Dates

First Submitted

February 8, 2026

First Posted

March 4, 2026

Study Start (Estimated)

June 30, 2026

Primary Completion (Estimated)

June 30, 2028

Study Completion (Estimated)

June 30, 2028

Last Updated

March 4, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share