Messaging-and-chatbot-assisted Nursing Consultation to Empower Family Members of Residents Living in Nursing Homes on Advance Care Planning (ChatACP)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 主要终点
- Recruitment feasibility
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
盲法说明
data analyst
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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)
研究组 & 干预措施
ChatACP Group
干预措施: ChatACP - Messaging- and-Chatbot Assisted Nursing Consultation (Behavioral)
Control group (ACP self-learning)
干预措施: ACP self- learning handout (Hong Kong Hospital Authority ACP education material) (Behavioral)
结局指标
主要结局
Recruitment feasibility
时间窗: 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.
Retention rate
时间窗: 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.
Percentage of Intervention Components Delivered in Compliance with the Intervention Protocol
时间窗: 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.
Participant Engagement Measured by Messaging Platform Interaction Logs and Self-Reported Message Reading Percentage
时间窗: 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: 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.
Mean Score of the Perceived Infographic Usability Scale (0-100% per Item)
时间窗: 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%.
Proportion of Participants Reporting High Satisfaction (Score 4-5) on all three items of the Investigator-Developed Acceptability Survey (5-Point Likert Scale)
时间窗: 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: 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
Intervention safety
时间窗: From enrollment to 3-month follow-ups
Risk assessment will be conducted using self-reported adverse events.
Background questionnaire
时间窗: at baseline (T0, prior to intervention)
The questionnaire includes demographics and care-related information.
Qualitative Findings on Feasibility and Acceptability of the Intervention Based on Semi-Structured Interviews
时间窗: 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.
次要结局
- 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))
研究者
Tongyao WANG
Research Assitant Professor
The University of Hong Kong