Social Needs StatusNCT07168382
AI-Based Personalized Health and Self-Care
A study testing DAPHNE Chatbot Intervention in people with Social Needs Status and Unmet Health-Related Social Needs and Access to Community Resources, run by Emre Sezgin at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Social Needs Status, Unmet Health-Related Social Needs and Access to Community Resources, Primary Health Care and Access to Primary Care
- What is being tested?
- DAPHNE Chatbot Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Apr 2026to Aug 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Due to the intervention only being translated into English, non-English Speakers will be excluded from this study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Nationwide Children's Hospital
Columbus, Ohio, 43207
Emre Sezgin, PhD, (614) 722-3179, Emre.Sezgin@nationwidechildrens.org
Emre Sezgin, PhD
About this study
Official title: AI-Based Personalized Health and Self-Care: Investigating A Mobile Virtual Assistant to Address Health-Related Social Needs
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:
Read more
- 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, Unmet Health-Related Social Needs and Access to Community Resources, Primary Health Care and Access to Primary Care, Technology Use to Support Caregivers, Caregiver Burden, Health Status, Child and Infant Care
- Being tested
- DAPHNE Chatbot Intervention, Standard HRSN Screening and Referral (Usual Care)
- Keywords
- Social Needs, Chatbot, Community Resources
- Medical subject headings
- Caregiver Burden
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DAPHNE Chatbot InterventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Chatbot Access | Experimental | 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. Receives: Behavioral: DAPHNE Chatbot Intervention |
| Standard of Care | Active comparator | 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. Receives: Other: Standard HRSN Screening and Referral (Usual Care) |
| Health Care Providers | Experimental | All health care providers will receive access to the chatbot. Receives: Behavioral: DAPHNE Chatbot Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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%.
Measured: 1 month 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%.
Measured: 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%.
Measured: 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.
Measured: Caregivers will complete at 3 months post-baseline and 6 months post-baseline.
Secondary outcomes (12)
User Chatbot Engagement
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.
Measured: Continuous through 6 months post-baseline
Provider Workflow Integration Expectancy
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.
Measured: Baseline and 6 months post-baseline
Caregiver Qualitative interview
Measured via qualitative themes. Caregivers will be interviewed about their perceptions of chatbot usability, acceptability, study procedures, and care experience.
Measured: 3 months and 6 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.
Measured: Baseline and 3 months post-baseline
Technical Performance Metrics
Measurement of the accuracy of chatbot's responses as a percent from 0 (no accuracy) to 100 (always accurate). Target ≥70%
Measured: Continuously throughout 6 months of study involvement.
Perceived Research Burden Assessment (PeRBA)
Survey measuring Caregiver burden related to study participation on a scale of 1 (most burden) to 5 (least burden). Target ≥4.
Measured: 1 month, 3 months, and 6 months post-baseline.
Recruitment rate
Measurment as a percentage of total recruitment goal reached over time and dropout rate.
Measured: Continuous throughout 6 months of study involvement.
Caregiver Quality of Life Survey
Survey measuring caregiver-reported quality of life changes on a scale of 1 (least satisfied) to 6 (most satisfied)
Measured: Baseline, 3 months post-baseline, and 6 months post-baseline.
Caregiver Stress Inventory
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).
Measured: Baseline, 3 months post-baseline, 6 months post-baseline.
Caregiver Self-Efficacy Scale
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).
Measured: Baseline, 3 months, and 6 months post-baseline.
Resource Access Satisfaction Survey
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).
Measured: 3 months and 6 months post-baseline.
Provider Qualitative Interview.
Health care providers will discuss their thoughts about using the app and offer opinions about the app and how it can improve.
Measured: Baseline and 6 months post-baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2025
- Study start24 Apr 2026
- Primary completionAug 2028 (estimated)
- Study completionAug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Social Needs StatusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Emre Sezgin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Emre Sezgin, Nationwide Children's Hospital
- Investigators
- Emre Sezgin, PhD, Principal investigator, Nationwide Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07168382
- Sponsor's protocol ID
- STUDY00004369
- Status last verified
- May 2026
- First submitted
- 14 Aug 2025
- Last updated
- 11 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 42008466Sezgin 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.
PubMed 41332826
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AI-Based Personalized Health and Self-Care: Investigating A Mobile Virtual Assistant to Address Health-Related Social Needs
- ClinicalTrials.gov ID
- NCT07168382
- Acronym / sponsor ID
- STUDY00004369
- 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, Caregiver Burden, Health Status, Child and Infant Care
- Keywords
- Social Needs, Chatbot, Community Resources
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Emre SezginUniversity, hospital or other
- Study start
- 24 Apr 2026 (actual)
- Primary completion
- Aug 2028 (estimated)
- Study completion
- Aug 2028 (estimated)
- First posted
- 11 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Chatbot Access | Experimental | Behavioral: DAPHNE Chatbot InterventionThe 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. |
| Standard of Care | Active comparator | Other: Standard HRSN Screening and Referral (Usual 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. |
| Health Care Providers | Experimental | Behavioral: DAPHNE Chatbot InterventionAll health care providers will receive access to the chatbot. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- 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
- Must be 18 years or older
Key exclusion criteria (1 listed)
- Due to the intervention only being translated into English, non-English Speakers will be excluded from this study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DAPHNE Chatbot InterventionThe 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. | Behavioural | Chatbot Access, Health Care Providers |
| 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. | Other | Standard of Care |
Primary outcome
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.
12 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2026.
- Derived from this study: PubMed 42008466Sezgin 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.
- Derived from this study: PubMed 41332826Sezgin 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Emre Sezgin, PhD principal investigator
Nationwide Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DAPHNE Chatbot Intervention in people with Social Needs Status and Unmet Health-Related Social Needs and Access to Community Resources, run by Emre Sezgin at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Emre Sezgin, PhD ((614) 722-3179, Emre.Sezgin@nationwidechildrens.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
System Usability Scale (SUS) (time frame: 1 month post-baseline and 3 months post-baseline for Caregivers. Providers will complete this at baseline only.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07168382, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2026.