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Идёт набор NCT07168382

AI-Based Personalized Health and Self-Care

Без фазы С лечением 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

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: DAPHNE Chatbot Intervention, Standard HRSN Screening and Referral (Usual Care).
Кому может быть актуально
Состояния в реестре: 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. Базовые параметры: Без ограничений · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

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

Обзор

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.

Вмешательства

  • Поведенческое 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
  • Другое 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.

Первичные конечные точки

  • System Usability Scale (SUS) [Срок оценки: 1 month post-baseline and 3 months post-baseline for Caregivers. Providers will complete this at baseline only.]
  • Web Evaluation Questionnaire (WEQ) [Срок оценки: 1 month and 3 months post-baseline]
  • Feasibility of Intervention Measure (FIM) [Срок оценки: Caregivers will complete at 3 months and 6 months post-baseline. Providers will complete at baseline and 6 months post-baseline.]
  • Retention Rate [Срок оценки: 1 month, 3 months, and 6 months post-baseline]
  • Social Determinants of Health [Срок оценки: Caregivers will complete at 3 months post-baseline and 6 months post-baseline.]
Вторичные конечные точки (12)
  • User Chatbot Engagement [Срок оценки: Continuous through 6 months post-baseline]
  • Provider Workflow Integration Expectancy [Срок оценки: Baseline and 6 months post-baseline]
  • Caregiver Qualitative interview [Срок оценки: 3 months and 6 months post-baseline.]
  • Patient Comprehension Questionnaire (PCQ) [Срок оценки: Baseline and 3 months post-baseline]
  • Technical Performance Metrics [Срок оценки: Continuously throughout 6 months of study involvement.]
  • Perceived Research Burden Assessment (PeRBA) [Срок оценки: 1 month, 3 months, and 6 months post-baseline.]
  • Recruitment rate [Срок оценки: Continuous throughout 6 months of study involvement.]
  • Caregiver Quality of Life Survey [Срок оценки: Baseline, 3 months post-baseline, and 6 months post-baseline.]
  • Caregiver Stress Inventory [Срок оценки: Baseline, 3 months post-baseline, 6 months post-baseline.]
  • Caregiver Self-Efficacy Scale [Срок оценки: Baseline, 3 months, and 6 months post-baseline.]
  • Resource Access Satisfaction Survey [Срок оценки: 3 months and 6 months post-baseline.]
  • Provider Qualitative Interview. [Срок оценки: Baseline and 6 months post-baseline]

Критерии участия

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

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Организация здравоохранения

Центры проведения

США · 1 центр
  • Nationwide Children's Hospital — Columbus

Публикации

  • 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

Идентификаторы

NCT: NCT07168382 · STUDY00004369

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗