NCT07168382 · Emre Sezgin
AI-Based Personalized Health and Self-Care
What this study is about
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 randomly assigned clinical trial.
View original scientific description
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 chatbot over a six-month period, including automated nudges, tailored prompts, and context-aware suggestions. The intervention is non-invasive and participant-driven.
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.
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)
Time frame: 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%.
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.
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
Time frame: 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
Time frame: Caregivers will complete at 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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
Where
- Columbus, Ohio
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 11, 2026 · Source of record for eligibility and locations