Achieving Health in Emerging Adults With Diabetes (AHEAD) Program: A Clinical Trial Designed to Understand if Participation in a Clinical Program Developed Specifically to Support Emerging Adults With Type 1 Diabetes Leads to Improved Diabetes Outcomes.
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: AHEAD Program.
- Кому может быть актуально
- Состояния в реестре: Diabetes Mellitus, Type 1 Diabetes. Базовые параметры: 16 лет — 19 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
Achieving Health in Emerging Adults With Diabetes (AHEAD) Study
Обзор
The goal of this study is to determine whether the Achieving Health in Emerging Adults with Diabetes (AHEAD) Program helps emerging adults with type 1 diabetes improve their blood glucose management during the transition from pediatric to adult care. Participants will be randomized to receive Usual Care or the AHEAD Program, which provides tailored support to emerging adults to build autonomy and competence to facilitate independent diabetes management. Researchers will compare changes in glycemia and participant-reported outcomes between groups.
Подробное описание
Many emerging adults with type 1 diabetes find it difficult to maintain their blood glucose levels within the recommended range most of the time. This can increase their risk for serious short- and long-term diabetes-related health problems. Managing diabetes becomes especially difficult during the transition from pediatric care to adult care when emerging adults are expected to manage their condition on their own.
The Achieving Health in Emerging Adults with Diabetes (AHEAD) Program was developed to support emerging adults with their transition to independence. It focuses on helping them build autonomy and competence needed to manage their diabetes independently. The program is based on self-determination theory and best practices for supporting successful health care transition to adult care.
In this study, 306 emerging adults will be randomly assigned to either the AHEAD Program or Usual Care arms. Participants will have 6 clinic visits and complete surveys prior to their clinic visits. AHEAD participants will receive support from a team of diabetes providers who have expertise in supporting emerging adults living with diabetes every three months. Usual Care participants will continue to receive the diabetes care as they do currently every three months.
Researchers will evaluate changes in glycemia and participant-reported outcomes (e.g., diabetes distress, transition readiness). The study will also assess the cost and cost-effectiveness of AHEAD, as well as factors related to its implementation.
Вмешательства
- Поведенческое AHEAD Program
Participants will complete self-assessments around health care transition readiness and mental health prior to an AHEAD clinic visit. Emerging adults will then received tailored clinical support based on their self-assessments and work to build their autonomy and competence to manage their diabetes and health care independently with the support of their AHEAD providers.
Первичные конечные точки
- Hemoglobin A1c (HbA1c) [Срок оценки: From enrollment (baseline clinic visit: 0 months) to the end of intervention period (6th clinic visit: 15-24 months).]
Вторичные конечные точки (11)
- Time In Ranges [Срок оценки: From enrollment (baseline clinic visit: 0 months) to the end of intervention period (6th clinic visit: 15-24 months).]
- Diabetes Distress [Срок оценки: From enrollment (baseline clinic visit: 0 months) to the end of intervention period (6th clinic visit: 15-24 months).]
- Diabetes-Specific Health Care Transition Readiness [Срок оценки: From enrollment (baseline clinic visit: 0 months) to the end of intervention period (6th clinic visit: 15-24 months).]
- General Health Care Transition Readiness [Срок оценки: From enrollment (baseline clinic visit: 0 months) to the end of intervention period (6th clinic visit: 15-24 months).]
- Diabetes Family Conflict [Срок оценки: From enrollment (baseline clinic visit: 0 months) to the end of intervention period (6th clinic visit: 15-24 months).]
- Relatedness [Срок оценки: From enrollment (baseline clinic visit: 0 months) to the end of intervention period (6th clinic visit: 15-24 months).]
- Autonomy Treatment Self-Regulation Questionnaire [Срок оценки: From enrollment (baseline clinic visit: 0 months) to the end of intervention period (6th clinic visit: 15-24 months).]
- Disordered eating [Срок оценки: From enrollment (baseline clinic visit: 0 months) to the end of intervention period (6th clinic visit: 15-24 months).]
- Depression [Срок оценки: From enrollment (baseline clinic visit: 0 months) to the end of intervention period (6th clinic visit: 15-24 months).]
- Generalized Anxiety [Срок оценки: From enrollment (baseline clinic visit: 0 months) to the end of intervention period (6th clinic visit: 15-24 months).]
- Social needs [Срок оценки: From enrollment (baseline clinic visit: 0 months) to the end of intervention period (6th clinic visit: 15-24 months).]
Критерии участия
Критерии включения
- 16-19 years of age
- Have had type 1 diabetes ≥ 12 months
- Had a recent HbA1c ≥7.0%
- Currently receive outpatient diabetes care at a Seattle Children's Hospital Diabetes Clinic located in Bellevue, Everett, Federal Way, or Seattle
- Are able to complete written surveys
- Will be able to receive clinical care in WA State for the next 2 years
Критерии исключения
- Have had a pilot program AHEAD clinic visit
- Most recent Usual Care diabetes visit was with a current AHEAD provider
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
- Лечение
Центры проведения
США · 1 центр
- Seattle Children's — Seattle
Идентификаторы
NCT: NCT07292558 · H25-03574 · 4-SRA-2024-1580-M-B