AI-Based Personalized Health and Self-Care: Investigating A Mobile Virtual Assistant to Address Health-Related Social Needs
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Web Evaluation Questionnaire (WEQ)
研究概览
简要总结
The goal of this clinical trial is to learn if the DAPHNE chatbot can improve caregiver engagement, usability, and integration of social care support tools into clinical workflows in caregivers of pediatric patients receiving care at the Nationwide Children's Hospital Primary Care Center (NCH PCC). This is a pilot randomized clinical trial.
The main questions it aims to answer are:
- Is the DAPHNE chatbot usable, acceptable, and minimally burdensome for caregivers over a 6-month period?
- Can the DAPHNE chatbot be effectively integrated into primary care provider workflows?
Researchers will compare the DAPHNE chatbot intervention arm to the standard of care control arm to see if the intervention improves caregiver-reported outcomes and provider workflow integration.
Participants that are patients will be randomly assigned to either the DAPHNE chatbot group or the standard of care group. Complete surveys assessing usability, acceptability, and burden and participate in brief qualitative interviews to share feedback on their experience.
Participants that are Primary Care providers will discuss integration of DAPHNE into clinical workflows and complete workflow integration assessments.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •(Caregivers):
- •Must be a caregiver of a child seen within the NCH primary care network who self-identifies with at least one unmet social need
- •Must be 18 years of age or older
- •Must be English-speaking
- •Must have a device that connects to the internet
- •Inclusion Criteria (Primary Care Providers and Support Team Members):
- •Must be 18 years or older
- •Must be employed at Nationwide Children's Hospital
排除标准
- •- Due to the intervention only being translated into English, non-English Speakers will be excluded from this study.
研究组 & 干预措施
Chatbot Access
The intervention consists of a conversational, AI-powered chatbot designed to identify and address health-related social needs (HRSN) among caregivers of pediatric patients. Delivered via a secure mobile- and web-based application, the chatbot facilitates natural language interactions to assess needs, generate personalized resource recommendations, and support real-time navigation to community-based services. Participants assigned to the intervention arm will have continuous access to the chatbot over a 6-month period, including automated messages, tailored prompts, and context-aware suggestions. The intervention is non-invasive and participant driven.
干预措施: DAPHNE Chatbot Intervention (Behavioral)
Standard of Care
Participants randomized to the control group will receive the standard of care health-related social needs (HRSN) screening and referral services as currently implemented in Nationwide Children's Hospital primary care clinics. These services include in-clinic social needs assessments conducted during routine visits and referrals to internal or external resources, such as social work or care coordination teams. Participants in this group will not receive access to the DAPHNE chatbot. Study-related surveys and outcome assessments will be equivalent across both groups.
干预措施: Standard HRSN Screening and Referral (Usual Care) (Other)
Health Care Providers
All health care providers will receive access to the chatbot.
干预措施: DAPHNE Chatbot Intervention (Behavioral)
结局指标
主要结局
Web Evaluation Questionnaire (WEQ)
时间窗: 1 month and 3 months post-baseline
Survey measuring the Caregiver's acceptability of the chatbot on a scale of 0% (lowest acceptability) to 100% (highest acceptability). Target ≥80%.
Retention Rate
时间窗: 1 month, 3 months, and 6 months post-baseline
Percentage of participants completing follow-up assessments, measured as a percentage. Target ≥70%.
System Usability Scale (SUS)
时间窗: 1 month post-baseline and 3 months post-baseline for Caregivers. Providers will complete this at baseline only.
Survey measuring the participant usability of the chatbot on a range of 0 (lowest usability) to 100 (highest usability). Target ≥68.
Web Evaluation Questionnaire (WEQ)
时间窗: 1 month and 3 months post-baseline
Survey measuring the Caregiver's acceptability of the chatbot on a scale of 0% (lowest acceptability) to 100% (highest acceptability). Target ≥80%.
Patient Comprehension Questionnaire (PCQ)
时间窗: Baseline and 3 months post-baseline
Survey measuring the Caregiver's comprehension of the chatbot prompts and recommendations on a scale of 1 (least comprehension) to 5 (most comprehension). Target ≥ 4.
Feasibility of Intervention Measure (FIM)
时间窗: Caregivers will complete at 3 months and 6 months post-baseline. Providers will complete at baseline and 6 months post-baseline.
Survey measuring participant ratings of feasibility of the study implementation on a scale of 0% (least feasible) to 100% (most feasible). Target ≥80%.
Retention Rate
时间窗: 1 month, 3 months, and 6 months post-baseline
Percentage of participants completing follow-up assessments, measured as a percentage. Target ≥70%.
Social Determinants of Health
时间窗: Caregivers will complete at baseline, 3 months post-baseline, and 6 months post-baseline.
This questionnaire is a common instrument used in clinical settings to identify health-related social needs.
次要结局
- Recruitment rate(Continuous throughout 6 months of study involvement.)
- Caregiver Quality of Life Survey(Baseline, 3 months post-baseline, and 6 months post-baseline.)
- User Chatbot Engagement(Continuous through 6 months post-baseline)
- Caregiver Qualitative interview(3 months and 6 months post-baseline.)
- Technical Performance Metrics(Continuously throughout 6 months of study involvement.)
- Perceived Research Burden Assessment (PeRBA)(1 month, 3 months, and 6 months post-baseline.)
- Caregiver Stress Inventory(Baseline, 3 months post-baseline, 6 months post-baseline.)
- Caregiver Self-Efficacy Scale(Baseline, 3 months, and 6 months post-baseline.)
- Resource Access Satisfaction Survey(3 months and 6 months post-baseline.)
- Perceived Research Burden Assessment (PeRBA)(1 month, 3 months, and 6 months post-baseline.)
- User Chatbot Engagement(Continuous through 6 months post-baseline)
- Recruitment rate(Continuous throughout 6 months of study involvement.)
- Caregiver Quality of Life Survey(Baseline, 3 months post-baseline, and 6 months post-baseline.)
- Provider Workflow Integration Expectancy(Baseline and 6 months post-baseline)
- Caregiver Qualitative interview(3 months and 6 months post-baseline.)
- Technical Performance Metrics(Continuously throughout 6 months of study involvement.)
- Caregiver Stress Inventory(Baseline, 3 months post-baseline, 6 months post-baseline.)
- Caregiver Self-Efficacy Scale(Baseline, 3 months, and 6 months post-baseline.)
- Resource Access Satisfaction Survey(3 months and 6 months post-baseline.)
- Provider Qualitative Interview.(Baseline and 6 months post-baseline)
研究者
Emre Sezgin
Principal Investigator
Nationwide Children's Hospital