- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание NCT02432586
Pilot Study: Intensive Education in a Residential Camp Setting for Families of Young Children With Type 1 Diabetes (TotCamp)
Обзор исследования
Статус
Условия
Вмешательство/лечение
Подробное описание
We propose to deliver a structured multidisciplinary family-centered intervention over a 3-day weekend, with a second similar "booster" session 6 months later. The intervention will be based at our regional diabetes camp, Camp Sweeney. The proposed camp encounters aim to provide:
- An opportunity for intensive education beyond that achievable in a single class, and without the unfavorable impacts of multiple weekday classes on family and work time.
- Varied educational modalities including didactic sessions, practical demonstrations and role playing.
- Close observation of each child throughout the day and night by experienced diabetes counselors and medical staff to identify and help correct maladaptive family behaviors.
- A safe environment where parents can participate in group therapy sessions without child care worries.
- An opportunity for age-appropriate child-centered educational and therapeutic activities.
- An opportunity for families to form mutually-supportive friendships.
- Fun weekends away where the parents have help caring for their diabetic children.
We will conduct this pilot study, which will enroll 18 preschool children age 3-5.5 years, with the goal of obtaining preliminary results for 15 subjects.
The primary outcome, to be determined approximately one month before and after each of the two camp sessions, is improvement in Hemoglobin A1c (HbA1c). This outcome will be compared with that of historical controls.
Exploratory Hypotheses:
Compared with pretreatment baseline and historical controls, subjects attending two 3-day sessions at a family diabetes camp will improve:
- HbA1c 3 months after the first camp session
- Hypoglycemia frequency, as measured by continuous glucose monitoring
- Medical system utilization, as measured by telephone call frequency and also by emergency room visits and hospitalizations
- Behavioral/QoL assessments, including the parents of young children version of the hypoglycemia fear survey (HFS-P-YC), the Behavioral Pediatrics Feeding Assessment Scale (BPFAS), and the general and diabetes modules of the PedsQL.
- Diabetes knowledge, assessed by questionnaire
- Development of friendships between subject families, assessed by questionnaire
Тип исследования
Регистрация (Действительный)
Фаза
- Непригодный
Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Описание
Inclusion Criteria:
- Age 3-5.5 years old (+/- 2 months) at the date of first camp session they are eligible to join.
- Child and Parents fluent in either English or Spanish.
- Type 1 diabetes mellitus diagnosed for at least 10 months previous to date of first camp they are eligible to join.
- Taking insulin
- Custodial parent or guardian (preferable both parents or guardians) willing to attend both session of camp and the activities scheduled for them.
- Parent or guardian must sign consent before any study procedures are performed.
Exclusion Criteria:
- Neonatal diabetes (diagnosis in the first 3 months of life) or documented MODY; i.e., a likely genetic form of diabetes rather than an autoimmune etiology.
- Post-surgical diabetes (e.g., pancreatectomy for congenital hyperinsulinism). Such patients often cannot secrete glucagon, leading to a particularly severe inability to defend against hypoglycemia.
- Other severe chronic disease (e.g., cancer, cystic fibrosis) which in the judgment of the investigator is likely to significantly affect glycemic control.
- Patients cannot be taking systemic corticosteroids at enrollment because of adverse effects on glycemic control, but we will not disqualify subjects who require such therapy during the study. Inhaled or topical corticosteroids are permissible.
- Patients with hypothyroidism or hyperthyroidism must be clinically euthyroid and have free T4 and TSH within age-appropriate reference ranges at last medically indicated testing. Patients with out of range values may be retested after medication dose adjustment.
- Developmental delay or behavioral disorder in the patient of sufficient severity, in the judgment of the investigator, to interfere with group activities.
- Medical or psychiatric disorder in a parent of sufficient severity, in the judgment of the investigator, to interfere with group activities.
- Celiac disease is not an exclusion criterion.
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Поддерживающая терапия
- Распределение: Н/Д
- Интервенционная модель: Одногрупповое задание
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
---|---|
Другой: Intensive Education
Attendance of 2 intensive education sessions
|
Participants will attend a 3 day family-centered, multidisciplinary, intensive education session at our regional diabetes camp, Camp Sweeney.
A second 'booster' session will be conducted 6 months later.
|
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
---|---|---|
Change in Hemoglobin A1c one month pre-camp to one month post-camp Session 1
Временное ограничение: One month pre-camp, one month post-camp
|
As compared to historical controls
|
One month pre-camp, one month post-camp
|
Change in Hemoglobin A1c one month pre-camp to one month post-camp Session 2
Временное ограничение: One month pre-camp, one month post-camp
|
As compared to historical controls
|
One month pre-camp, one month post-camp
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
---|---|---|
Change in Hypoglycemia frequency one month pre-camp to one month post-camp Session 1
Временное ограничение: One month pre-camp, one month post-camp
|
As measured by continuous glucose monitoring, and quantitated as area under the curve for blood glucoses <70 mg/dL.
|
One month pre-camp, one month post-camp
|
Change in Hypoglycemia frequency one month pre-camp to one month post-camp Session 2
Временное ограничение: One month pre-camp, one month post-camp
|
As measured by continuous glucose monitoring, and quantitated as area under the curve for blood glucoses <70 mg/dL.
|
One month pre-camp, one month post-camp
|
Medical system utilization ( emergency room visits, hospitalizations related to T1DM)
Временное ограничение: Duration of participation in study, expected to be 10 months
|
Composite measure.
As compared to historical controls.
|
Duration of participation in study, expected to be 10 months
|
Change in PedsQL Family Impact Module one month pre-camp to one month post-camp Session 1
Временное ограничение: One month pre-camp, one month post-camp
|
Parent report
|
One month pre-camp, one month post-camp
|
Change in PedsQL Family Impact Module one month pre-camp to one month post-camp Session 2
Временное ограничение: One month pre-camp, one month post-camp
|
Parent report
|
One month pre-camp, one month post-camp
|
Change in PedsQL Pediatric Quality of Life Inventory one month pre-camp to one month post-camp Session 1
Временное ограничение: One month pre-camp, one month post-camp
|
Parent report for Toddlers, Parent report for Young Children, Young Child Report
|
One month pre-camp, one month post-camp
|
Change in PedsQL Pediatric Quality of Life Inventory one month pre-camp to one month post-camp Session 2
Временное ограничение: One month pre-camp, one month post-camp
|
Parent report for Toddlers, Parent report for Young Children, Young Child Report
|
One month pre-camp, one month post-camp
|
Change in PedsQL Diabetes Module one month pre-camp to one month post-camp Session 1
Временное ограничение: One month pre-camp, one month post-camp
|
Parent report for Toddlers, Parent report for Young Children, Young Child Report
|
One month pre-camp, one month post-camp
|
Change in PedsQL Diabetes Module one month pre-camp to one month post-camp Session 2
Временное ограничение: One month pre-camp, one month post-camp
|
Parent report for Toddlers, Parent report for Young Children, Young Child Report
|
One month pre-camp, one month post-camp
|
Change in Hypoglycemia Fear Survey one month pre-camp to one month post-camp Session 1
Временное ограничение: One month pre-camp, one month post-camp
|
Parents of young children version
|
One month pre-camp, one month post-camp
|
Change in Hypoglycemia Fear Survey one month pre-camp to one month post-camp Session 2
Временное ограничение: One month pre-camp, one month post-camp
|
Parents of young children version
|
One month pre-camp, one month post-camp
|
Change in Behavioral Pediatrics Feeding Assessment one month pre-camp to one month post-camp Session 1
Временное ограничение: One month pre-camp, one month post-camp
|
Behavior section
|
One month pre-camp, one month post-camp
|
Change in Behavioral Pediatrics Feeding Assessment one month pre-camp to one month post-camp Session 2
Временное ограничение: One month pre-camp, one month post-camp
|
Behavior section
|
One month pre-camp, one month post-camp
|
Соавторы и исследователи
Следователи
- Главный следователь: Perrin White, MD, UT Southwestern Medical Center
Даты записи исследования
Изучение основных дат
Начало исследования
Первичное завершение (Действительный)
Завершение исследования (Действительный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Оценивать)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- STU 042014-061
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
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