AI-Based Personalized Health and Self-Care
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: DAPHNE Chatbot Intervention, Standard HRSN Screening and Referral (Usual Care).
- Who it may be relevant to
- Registry conditions: Social Needs Status, Unmet Health-Related Social Needs and Access to Community Resources, Primary Health Care and Access to Primary Care, Technology Use to Support Caregivers. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
AI-Based Personalized Health and Self-Care: Investigating A Mobile Virtual Assistant to Address Health-Related Social Needs
Overview
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.
Interventions
- Behavioral DAPHNE Chatbot Intervention
The DAPHNE intervention consists of a conversational, AI-powered chatbot designed to identify and address health-related social needs (HRSNs) 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 - Other Standard HRSN Screening and Referral (Usual Care)
Participants randomized to the control group will receive the standard-of-care 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.
Primary outcome measures
- System Usability Scale (SUS) [Time frame: 1 month post-baseline and 3 months post-baseline for Caregivers. Providers will complete this at baseline only.]
- Web Evaluation Questionnaire (WEQ) [Time frame: 1 month and 3 months post-baseline]
- Feasibility of Intervention Measure (FIM) [Time frame: Caregivers will complete at 3 months and 6 months post-baseline. Providers will complete at baseline and 6 months post-baseline.]
- Retention Rate [Time frame: 1 month, 3 months, and 6 months post-baseline]
- Social Determinants of Health [Time frame: Caregivers will complete at 3 months post-baseline and 6 months post-baseline.]
Secondary outcome measures (12)
- User Chatbot Engagement [Time frame: Continuous through 6 months post-baseline]
- Provider Workflow Integration Expectancy [Time frame: Baseline and 6 months post-baseline]
- Caregiver Qualitative interview [Time frame: 3 months and 6 months post-baseline.]
- Patient Comprehension Questionnaire (PCQ) [Time frame: Baseline and 3 months post-baseline]
- Technical Performance Metrics [Time frame: Continuously throughout 6 months of study involvement.]
- Perceived Research Burden Assessment (PeRBA) [Time frame: 1 month, 3 months, and 6 months post-baseline.]
- Recruitment rate [Time frame: Continuous throughout 6 months of study involvement.]
- Caregiver Quality of Life Survey [Time frame: Baseline, 3 months post-baseline, and 6 months post-baseline.]
- Caregiver Stress Inventory [Time frame: Baseline, 3 months post-baseline, 6 months post-baseline.]
- Caregiver Self-Efficacy Scale [Time frame: Baseline, 3 months, and 6 months post-baseline.]
- Resource Access Satisfaction Survey [Time frame: 3 months and 6 months post-baseline.]
- Provider Qualitative Interview. [Time frame: Baseline and 6 months post-baseline]
Eligibility criteria
Inclusion Criteria (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
Exclusion criteria
\- Due to the intervention only being translated into English, non-English Speakers will be excluded from this study.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Health services research
Study locations
United States · 1 center
- Nationwide Children's Hospital — Columbus
Publications
- Sezgin E, Clarkson E, Logan F, Jackson DI, Hussain SA, Stokes J, Bunger A, Brock G, Fosler-Lussier E, Kemper AR, Pai AL. An AI-based chatbot to support health-related social needs among pediatric primary care population: Protocol for a pilot randomized controlled trial. PLoS One. 2026 Apr 20;21(4):e0337868. doi: 10.1371/journal.pone.0337868. eCollection 2026. PMID 42008466
- Sezgin E, Clarkson E, Logan F, Jackson DI, Hussain SA, Stokes J, Bunger A, Brock G, Fosler-Lussier E, Kemper AR, Pai AL. An AI-Based Chatbot to Support Health-Related Social Needs among Pediatric Primary Care Population: Protocol for a Pilot Randomized Controlled Trial. medRxiv [Preprint]. 2025 Nov 19:2025.11.17.25340433. doi: 10.1101/2025.11.17.25340433. PMID 41332826
Identifiers
NCT: NCT07168382 · STUDY00004369