Pilot-Testing Strategies to Improve Outcomes for Youth With Type 2 Diabetes by Addressing Health-Related Social Needs
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: Tailored Resources, Universal Empowerment, Text Messages, Community Health Workers (CHW).
- Кому может быть актуально
- Состояния в реестре: Diabetes in Adolescence, Type 2 Diabetes, Social Needs. Базовые параметры: от 13 лет · 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
Optimizing Navigation for Wellness And Resources Utilization in Youth With Type 2 Diabetes
Обзор
The goal of this clinical trial is to pilot test different strategies to address health related social needs (HRSN) experienced by adolescent and young adult patients with type 2 diabetes and their families. The main questions it aims to answer are: * How feasible are the strategies? * How acceptable are the strategies? * How reliably and consistently can the strategies be implemented? Participants will: Attend regularly scheduled diabetes clinic visits. Complete surveys and interviews. Be connected to community resources and organizations to help address HRSN.
Вмешательства
- Поведенческое Tailored Resources
Participants will be offered resource lists and warm referrals specific to health-related social needs (HRSN) on a screener. Their clinical team will be sent screener results and asked to talk about and address HRSN at the visit without additional guidance. Participants will be offered physical resources related to disclosed HRSN (e.g., food box for food insecurity). - Поведенческое Universal Empowerment
Regardless of disclosed health-related social needs (HRSN), participants will be offered resource lists and warm referral links for food, housing, and transportation needs. At clinic visit, all will be offered physical resources and the opportunity to meet with a social worker. In place of screening results, the clinical team will be sent a message requesting that, when seeing the patient in clinic, they use the provided, easily accessible empowering script about HRSN. - Поведенческое Text Messages
Participants will receive text messages once per month for 3 months. Messages will state that community-based resources to address health-related social needs (HRSN) are available if needed, with a link to opt-in to resource lists and warm referral links. Messages will include contact information for the study and clinical teams for optional HRSN discussion. Community Health Worker will not be assigned. - Поведенческое Community Health Workers (CHW)
Participants will be assigned a trained CHW to support connection with resources to address HRSN.
Первичные конечные точки
- Acceptability of Intervention: Health-Related Social Needs Screener [Срок оценки: at baseline clinic visit]
- Acceptability of Intervention: Tailored Approach to Address Health-Related Social Needs [Срок оценки: 1-week after baseline; 3 months]
- Acceptability of Intervention: Universal Empowerment Approach to Address Health-Related Social Needs [Срок оценки: at baseline visit; 1-week after baseline; 3 months]
- Acceptability of Intervention: Text Messages to Address Health-Related Social Needs [Срок оценки: 3 months]
- Acceptability of Intervention: Community Health Workers to Address Health-Related Social Needs [Срок оценки: 3 months]
- Fidelity of Intervention [Срок оценки: 1-week after baseline; 3 months; 6 months]
Вторичные конечные точки (5)
- Health-related social needs: Food Insecurity [Срок оценки: Baseline, 3 months, 6 months]
- Health-related social needs: Housing Insecurity [Срок оценки: Baseline, 3 months, 6 months]
- Health-related social needs: Transportation Insecurity [Срок оценки: Baseline, 3 months, 6 months]
- Hemoglobin A1C [Срок оценки: Baseline, 3 months, 6 months]
- Body Mass Index [Срок оценки: Baseline, 3 months, 6 months]
Критерии участия
Adolescent-Caregiver Dyads will be recruited together.
Adolescent Inclusion Criteria:
- Age 13 to 22 years old
- known diagnosis of type 2 diabetes
- followed clinically at UPMC Children's Hospital of Pittsburgh
- able to provide assent/consent
Caregiver Inclusion Criteria:
- Adult (18 years or older) identifying as a primary caretaker of an adolescent or young adult with type 2 diabetes
- Has an adolescent/young adult who agrees to participate in the study
- able to provide consent
Критерии исключения
- Inability to complete study questionnaires in English
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Да
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Факторный дизайн
- Маскирование
- Открытое
- Основная цель
- Организация здравоохранения
Центры проведения
США · 1 центр
- UPMC Children's Hospital of Pittsburgh — Pittsburgh
Идентификаторы
NCT: NCT07216118 · STUDY25030030 · 1R01DK142766-01