E-diary vs Paper Diary in Binge Eating Disorder
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: The subject will complete e-diary for 2 weeks, complete paper diary for 2 weeks.
- Кому может быть актуально
- Состояния в реестре: Binge Eating Disorder. Базовые параметры: до 18 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
A Mixed Methods, Observational, Cross-over Study of Measurement Comparability and Usability of Electronic and Paper Formats of a Binge Eating Diary
Обзор
The purpose of this study is to examine how binge eating episodes are recorded using two different diary formats: a paper diary and an electronic diary and to see whether both formats collect information in the same way and to understand which of the two formats is easier to use
Подробное описание
Binge eating (BE) diary has already been successfully employed to measure binge eating behavior in clinical trials. This has been implemented using a paper diary (p-diary) completed daily in the evening. From the diary records, binge eating episodes are confirmed by a healthcare professional. Despite the advantages of electronic implementation and the clinical and research need for such a tool, no electronic diary (e-diary) has been systematically tested in comparison to paper diary through an empirical study.
The following scientific questions are to be answered with this project
1. Are the paper and electronic diary formats considered measurement comparable, such that data collected using the different formats across different studies or programs could be directly comparable? 2. Are there differences in usability that might limit completion rates or lead to under reporting using one or the other mode of data collection?
Вмешательства
- Другое The subject will complete e-diary for 2 weeks
The subject will complete one diary format and switch to the other after 2 weeks - Другое complete paper diary for 2 weeks
complete paper diary for 2 weeks
Первичные конечные точки
- The primary endpoint is the comparison of number of binge eating episodes recorded over a 14-day period between diary formats [Срок оценки: from enrollment v1,day 0 to v3,day 30]
Критерии участия
Критерии включения
- Diagnosis of Binge Eating Disorder based on The Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) (5) criteria (as assessed with BED module of the structural clinical interview \[SCID\] (6) for DSM-5)
- Reported frequency of minimum of 2 binge episodes/week
- Age: over 18 years of age
- Ability to understand and complete self-reporting measures 5 . The subject owns a smartphone compatible with Google Play or Apple App Store and is able to download and use apps appropriately.
Критерии исключения
- Comorbid psychiatric conditions requiring immediate hospitalization (as assessed with MSE)
- IInability to use smartphone or paper diary due to physical limitations or technical barriers (e.g., severe visual impairment)
- Inability to read/write in English
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Перекрёстный дизайн
- Маскирование
- Открытое
- Основная цель
- Другое
Центры проведения
США · 1 центр
- Lindner Center of HOPE — Mason
Идентификаторы
NCT: NCT07715812 · A-3650-0001