Behavioral Approaches to Reduce Diabetes Distress in Adults With Type 1 Diabetes: A Pragmatic SMART
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: ReCharge, TakeCharge.
- Кому может быть актуально
- Состояния в реестре: Diabetes type1, Diabetes Mellitus, Type 1, Diabetes, Autoimmune, Diabetes Mellitus. Базовые параметры: от 30 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
Fusing Rapid-cycle Testing and Adaptive Trial Designs: A Scientific Pipeline to Translate and Individualize Evidence-based Psychosocial and Behavioral Interventions in Routine Type 1 Diabetes Care
Обзор
This study is designed to compare two behavioral approaches to reduce diabetes distress ("the expected burdens, concerns, fears, and threats that arise from the challenges of living with diabetes") in adults with type 1 diabetes. At the study baseline, participants will be randomized to take part in one of two virtual, group-based interventions (the "Primary" intervention) utilizing either an emotions-focused or a problem-solving approach to reduce diabetes distress. After the initial intervention, participants will complete surveys to assess their response to the material. Participants who are determined to be "non-responders" (i.e., the Primary intervention was not effective) will be re-randomized to one of two "Supplementary" interventions, which will include individualized sessions to learn and/or practice strategies related to either the psychological or problem-solving approach.
Подробное описание
The study will compare the effectiveness of an emotions-focused approach with a problem-solving based approach to reduce diabetes distress (DD). The investigators will enroll N=200 adults 30 years and older with type 1 diabetes (T1D) and elevated DD from a single clinical site to participate in a 12-week study. All interventions and assessments will be delivered in a pragmatic and entirely virtual format. The investigators will utilize a precision medicine trial design (Sequential Multiple Assignment Randomized Trial; SMART) to compare two evidence-based, virtual group interventions to reduce DD in adults with T1D (primary aim). The secondary aims of the study are to estimate next best steps for participants who do not respond to group-based interventions, and to estimate optimal treatments or sequences of treatments for different individuals based on their individual characteristics, including response to prior treatment.
The study includes an initial randomization to one of two 5-week Primary Interventions: "ReCharge", an Acceptance and Commitment Therapy (ACT)-focused approach that will help to reduce the emotional burden of diabetes management; or "TakeCharge", a problem-solving focused approach that will equip participants with new skills to manage type 1 diabetes. Participants will complete a series of assessments to determine their response to the Primary Intervention. Participants who did not respond to the Primary Intervention will be re-randomized to participate in one of two Supplementary Interventions over a 5-week period, where they will have three virtual, individualized sessions for exposure and practice with either the ReCharge or TakeCharge curriculum.
The investigators will evaluate the Reach, Effectiveness, Adoption, Implementation, and Maintenance of all phases of the study. By collecting both quantitative data and key qualitative feedback from providers and participants, the investigators will be able to assess and improve the pragmatic design of these evidence-based interventions for routine integration into healthcare settings. Completion of primary and secondary aims will inform a future program which saves resources and expands the availability of guidelines-oriented care to all patients with T1D.
Вмешательства
- Поведенческое ReCharge
ReCharge is an emotions-focused intervention that utilizes core components of Acceptance and Commitment Therapy (ACT) to address and minimize diabetes distress. This 5-week, group-based, virtual intervention will include a stepwise process to address diabetes distress and provide opportunities to practice new skills. Weekly assignments between the sessions will reinforce class material and give additional practice opportunities. Participants will be expected to interact in each session and will - Поведенческое TakeCharge
TakeCharge is a problem-solving focused intervention that empowers participants to identify and make meaningful changes in their blood glucose management and other diabetes-related behaviors. This 5-week, group-based, virtual intervention will include a stepwise process to analyze data and resolve challenging situations surrounding diabetes management and provide opportunities to practice new skills. Weekly assignments between the sessions will reinforce class material and give additional practi
Первичные конечные точки
- Change in Total Diabetes Distress (T1-DDS Total Score) [Срок оценки: Baseline, Interim (6 weeks), Endpoint (12 weeks)]
Вторичные конечные точки (12)
- Change in Core Diabetes Distress (T1-DDAS Core Score) [Срок оценки: Baseline, Interim (6 weeks), Endpoint (12 weeks)]
- Change in Sources of Diabetes Distress (T1-DDS Subscale Scores) [Срок оценки: Baseline, Interim (6 weeks), Endpoint (12 weeks)]
- Change in Perceived Stress [Срок оценки: Baseline, Interim (6 weeks), Endpoint (12 weeks)]
- Change in Diabetes Quality of Life [Срок оценки: Baseline, Interim (6 weeks), Endpoint (12 weeks)]
- Change in Perceived Confidence in Diabetes [Срок оценки: Baseline, Interim (6 weeks), Endpoint (12 weeks)]
- Change in Diabetes Specific Self-Compassion [Срок оценки: Baseline, Interim (6 weeks), Endpoint (12 weeks)]
- Change in Hypoglycemic Attitudes and Behaviors [Срок оценки: Baseline, Interim (6 weeks), Endpoint (12 weeks)]
- Change in Hemoglobin A1c (HbA1c) [Срок оценки: Baseline, Endpoint (12 weeks)]
- Change in Percent of Time in Range (TIR) [Срок оценки: Baseline, Endpoint (12 weeks)]
- Change in Percent of Time Below Range (TBR) [Срок оценки: Baseline, Endpoint (12 weeks)]
- Change in Percent of Time Above Range (TAR) [Срок оценки: Baseline, Endpoint (12 weeks)]
- Glycemic Variability [Срок оценки: Baseline, Endpoint (12 weeks)]
Критерии участия
Критерии включения
- Adults 30 years and older
- Type 1 diabetes OR latent autoimmune diabetes in adults (LADA) clinically managed as type 1 diabetes
- Elevated diabetes distress, defined as a score >= 2.0 on the T1-DDAS core scale
- English speaking
Критерии исключения
- Does not receive diabetes care at UNC Endocrinology at Eastowne
- Cannot commit to the pre-scheduled weekly, virtual sessions
- Diagnosis of any major medical or psychiatric condition that would preclude participation
- Diagnosis of dementia or other conditions that affect memory or information retention, such as cognitive impairment
- Visual or auditory impairment that would interfere with participation in a group intervention
- Receiving inpatient psychiatric treatment or history of a suicide attempt within the past 12 months at the time of enrollment
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Последовательный дизайн
- Маскирование
- Двойное слепое
- Основная цель
- Лечение
Центры проведения
США · 1 центр
- University of North Carolina at Chapel Hill — Chapel Hill
Идентификаторы
NCT: NCT06405373 · 23-2228b · 12-22-ACE-18