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NCT Number: NCT07168382

AI-Based Personalized Health and Self-Care

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.

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Key information

Conditions

Social Needs Status Behavior Behavioral Symptoms Caregiver Burden Health Status, Child and Infant Care Preventative Care Services Primary Health Care and Access to Primary Care Stress, Psychological Technology Use to Support Caregivers Unmet Health-Related Social Needs and Access to Community Resources

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nationwide Children's Hospital

Columbus, Ohio, 43207, United States

Location status: Recruiting

Location contact

Emre Sezgin, PhD

CONTACT

[email protected]

(614) 722-3179

Emre Sezgin, PhD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

DAPHNE Chatbot Intervention

Behavioral

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.

Standard HRSN Screening and Referral (Usual Care)

Other

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 outcomes

  1. 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.

  2. 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%.

  3. 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%.

  4. 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%.

  5. 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.

Secondary outcomes

  1. User Chatbot Engagement

    Time frame: Continuous through 6 months post-baseline

    Measured via a log that captures total minutes participants spent using the chatbot, total number of logins, session durations, screenings completed, and number of resources accessed.

  2. Provider Workflow Integration Expectancy

    Time frame: Baseline and 6 months post-baseline

    Survey measuring Provider rating of ease of chatbot workflow integration on a scale of 1 (lowest ease of integration) to 5 (highest ease of integration). Target ≥4.

  3. Caregiver Qualitative interview

    Time frame: 3 months and 6 months post-baseline.

    Measured via qualitative themes. Caregivers will be interviewed about their perceptions of chatbot usability, acceptability, study procedures, and care experience.

  4. Patient Comprehension Questionnaire (PCQ)

    Time frame: 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.

  5. Technical Performance Metrics

    Time frame: Continuously throughout 6 months of study involvement.

    Measurement of the accuracy of chatbot's responses as a percent from 0 (no accuracy) to 100 (always accurate). Target ≥70%

  6. Perceived Research Burden Assessment (PeRBA)

    Time frame: 1 month, 3 months, and 6 months post-baseline.

    Survey measuring Caregiver burden related to study participation on a scale of 1 (most burden) to 5 (least burden). Target ≥4.

  7. Recruitment rate

    Time frame: Continuous throughout 6 months of study involvement.

    Measurment as a percentage of total recruitment goal reached over time and dropout rate.

  8. Caregiver Quality of Life Survey

    Time frame: Baseline, 3 months post-baseline, and 6 months post-baseline.

    Survey measuring caregiver-reported quality of life changes on a scale of 1 (least satisfied) to 6 (most satisfied)

  9. Caregiver Stress Inventory

    Time frame: Baseline, 3 months post-baseline, 6 months post-baseline.

    Survey measuring caregiver stress levels and contributors to stress over time. Survey is a series of statements and caregivers record how much they agree with the statement on a scale of 1 (strongly disagree) to 5 (strongly agree).

  10. Caregiver Self-Efficacy Scale

    Time frame: Baseline, 3 months, and 6 months post-baseline.

    Survey measuring Caregiver levels of self-efficacy in managing care and navigating resources. Survey is a series of statements and caregivers record how much they agree with the statement on a scale of 1 (strongly disagree) to 5 (strongly agree).

  11. Resource Access Satisfaction Survey

    Time frame: 3 months and 6 months post-baseline.

    Survey completed by a Caregiver measuring how likely they are to recommend the intervention to someone who needs help finding health and/or social resources on a scale of 1 (least likely) to 10 (most likely).

  12. Provider Qualitative Interview.

    Time frame: Baseline and 6 months post-baseline

    Health care providers will discuss their thoughts about using the app and offer opinions about the app and how it can improve.

Other outcomes

  1. Provider Survey on Standard of Care

    Time frame: Baseline and 6 months post-baseline.

    Survey detailing providers pre-intervention standard workflows for addressing Health-Related Social Needs.

  2. Electronic Health Record Review of Health-Related Social Needs (HRSN) Interventions

    Time frame: 3 months and 6 months post-baseline

    Frequency and types of HRSN interventions documented in Caregiver's EHR

  3. Completed Health-Related Social Needs (HRSN) referrals.

    Time frame: 3 months and 6 months post-baseline

    Number of HRSN referrals completed by Caregiver (e.g., social services, specialty care).

  4. Primary Care Visit Completion.

    Time frame: 3 months and 6 months post-baseline

    Percentage of completed primary care visits (i.e., Caregiver visit adherence).

  5. Missed Appointments

    Time frame: 3 months and 6 months post-baseline.

    Number of caregiver missed/no-show clinic visits

  6. Emergency Department Visits

    Time frame: 3 months and 6 months post-baseline

    Number of Emergency Department Visits per Caregiver

  7. Healthcare Cost Avoidance

    Time frame: 3 months and 6 months post-baseline

    Estimated cost avoidance from improved visit adherence and reduced ED utilization. Reported by Caregivers in USD.

Study contacts

Contact information is provided by the study sponsor or research team.

Emre Sezgin, PhD

CONTACT

[email protected]

(614) 722-3179

Sponsors and collaborators

Lead sponsor

Emre Sezgin

Other

Registry information

Official study title

AI-Based Personalized Health and Self-Care: Investigating A Mobile Virtual Assistant to Address Health-Related Social Needs

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Sep 11, 2025
Registry last updated
May 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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