AI-Based Personalized Health and Self-Care

NCT07168382 | Not Yet Recruiting DMC

• 1 other identifier: STUDY00004369
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Social Needs Status

Keywords

Social Needs; Chatbot; Community Resources

Outcome Measures

Primary Outcomes (6)

• System Usability Scale (SUS)

  Survey measuring the participant usability of the chatbot on a range of 0 (lowest usability) to 100 (highest usability). Target ≥68.

  1 month post-baseline and 3 months post-baseline for Caregivers. Providers will complete this at baseline only.

• Web Evaluation Questionnaire (WEQ)

  Survey measuring the Caregiver's acceptability of the chatbot on a scale of 0% (lowest acceptability) to 100% (highest acceptability). Target ≥80%.

  1 month and 3 months post-baseline

• Patient Comprehension Questionnaire (PCQ)

  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.

  Baseline and 3 months post-baseline

• Feasibility of Intervention Measure (FIM)

  Survey measuring participant ratings of feasibility of the study implementation on a scale of 0% (least feasible) to 100% (most feasible). Target ≥80%.

  Caregivers will complete at 3 months and 6 months post-baseline. Providers will complete at baseline and 6 months post-baseline.

• Retention Rate

  Percentage of participants completing follow-up assessments, measured as a percentage. Target ≥70%.

  1 month, 3 months, and 6 months post-baseline

• Social Determinants of Health

  This questionnaire is a common instrument used in clinical settings to identify health-related social needs.

  Caregivers will complete at baseline, 3 months post-baseline, and 6 months post-baseline.

Secondary Outcomes (11)

• User Chatbot Engagement

  Continuous through 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.

• Perceived Research Burden Assessment (PeRBA)

  1 month, 3 months, and 6 months post-baseline.

Other Outcomes (7)

• Provider Survey on Standard of Care

  Baseline and 6 months post-baseline.

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

  3 months and 6 months post-baseline

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

  3 months and 6 months post-baseline

Study Arms (3)

Chatbot Access

EXPERIMENTAL

These participants will receive access to the chatbot

Behavioral: DAPHNE Chatbot Intervention

Standard of Care

ACTIVE COMPARATOR

Participants will not receive access to the DAPHNE chatbot. These individuals will receive the usual HRSN screening/referral procedures at Nationwide Children's Hospital.

Other: Standard HRSN Screening and Referral (Usual Care)

Health Care Providers

EXPERIMENTAL

All health care providers will receive access to the chatbot.

Behavioral: DAPHNE Chatbot Intervention

Interventions

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.

Chatbot Access; Health Care Providers

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.

Standard of Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Must be 18 years or older
• At least one unmet social need
• Low-income
• Currently under Medicaid/Medicare insurance or have no coverage
• Must be 18 years or older
• Must be employed at Nationwide Children's Hospital

You may not qualify if:

• \- Due to the intervention only being translated into English, non-English Speakers will be excluded from this study.

Sponsors & Collaborators

• Emre Sezgin: lead

Study Sites (1)

Nationwide Children's Hospital

Columbus, Ohio, 43207, United States

Location

Related Publications (1)

• 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 DERIVED

MeSH Terms

Interventions

Referral and Consultation

Intervention Hierarchy (Ancestors)

Professional Practice; Organization and Administration; Health Services Administration

Study Officials

• Emre Sezgin, PhD

  Nationwide Children's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Emre Sezgin, PhD

CONTACT

(614) 722-3179; Emre.Sezgin@nationwidechildrens.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 14, 2025
• First Posted: September 11, 2025
• Study Start: March 1, 2026
• Primary Completion (Estimated): August 1, 2028
• Study Completion (Estimated): August 1, 2028
• Last Updated: February 27, 2026

Record last verified: 2026-02

Locations

US (1)