- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание NCT03998267
Qatar Diabetes Mobile Application Trial (QDMAT)
Обзор исследования
Статус
Условия
Вмешательство/лечение
Тип исследования
Регистрация (Ожидаемый)
Фаза
- Непригодный
Контакты и местонахождение
Контакты исследования
- Имя: Noor N Suleiman, MD
- Номер телефона: +97455816515
- Электронная почта: nsuleiman@hamad.qa
Учебное резервное копирование контактов
- Имя: Dabia H Al Mohanadi
- Номер телефона: +97455524801
- Электронная почта: DAlMohanadi@hamad.qa
Места учебы
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Doha, Катар
- Рекрутинг
- Hamad General Hospital
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Контакт:
- Noor Suleiman, MD
- Электронная почта: nsuleiman@hamad.qa
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Описание
Inclusion Criteria:
• Adults with T2DM (more than 18 yrs of age and younger than 60) who are able to provide consent
- Arabic speaking and non-arabic speaking T2DM patients, who can communicate in Arabic and or English language.
- Uncontrolled diabetes with HbA1c more than or equal to 8.5%
- T2DM on insulin with or without any other oral medication
- Subject must have a smart phone (must be an iOS (Apple) phone user) and must be interested in using a smart phone app.
- Subject must have no visual impairment.
- Minimal level of literacy (able to read and write in english or arabic).
- To be able to communicate via chat with the mobile app team through the app as evidenced by at least weekly use of any of the social media such as WhatsApp, Viber, Facebook Messenger etc
- Subject must be willing to utilize a mobile application for diabetes control
Exclusion Criteria:
• Recent history (3 months) of stroke or Myocardial infarction.
- Patients with proliferating retinopathy
- Patients with an acute illness during the past 2 weeks.
- Patients who plan to be away for more than 3 months.
- Patients with CKD requiring dialysis.
- Hypoglycemia unawareness.
- More than one episode of severe hypoglycemia in the previous 6 months.
- Female patients who are planning for pregnancy in the coming 6 months.
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Поддерживающая терапия
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
---|---|
Активный компаратор: Intervention arm
For the subjects using the app (intervention group): The mobile app team shall do the following:
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A new mobile application, specifically built for the diabetes patients in Qatar with the help of local expertise.
Standard of care including physicians, dietetics and diabetes educators support
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Плацебо Компаратор: Standard of care arm
For the subjects not using the app (the standard of care group):
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Standard of care including physicians, dietetics and diabetes educators support
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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
---|---|---|
Difference in mean HbA1c
Временное ограничение: 6 months
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Difference in mean HbA1C between the intervention arm and the standard care
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6 months
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Difference in mean HbA1c
Временное ограничение: 3 months
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Difference in mean HbA1C between the intervention arm and the standard care
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3 months
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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
---|---|---|
Subject perceptions of diabetes self management
Временное ограничение: 6 months
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Within subject changes in perceptions of diabetes self-management as assessed by diabetes self-management questionnaire (DSMQ) scores subsection glucose management and overall rating.
DSM-Q is a 16 item questionnaire to assess self-care activities associated with glycemic control.
Four subscales, 'Glucose Management' (GM), 'Dietary Control' (DC), 'Physical Activity' (PA), and 'Health-Care Use' (HU), as well as a 'Sum Scale' (SS) as a global measure of self-care.
Scale scores are calculated as sums of item scores and then transformed to a scale ranging from 0 to 10 (raw score / theoretical maximum score * 10.
A transformed score of ten thus represents the highest self-rating of the assessed behavior
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6 months
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Change in subjects attitudes towards disease
Временное ограничение: 6 months
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Within subject changes in attitudes towards disease assessed the proportion of subjects with diabetes distress scales (DDS) scores consistent with moderate or high distress.The DDS yields a total distress score plus 4 subscale (emotional burden,physical distress, regimen distress and interpersonal distress) scores each addressing a different kind of distress.
A mean item score 2.0-2.9 is considered moderate distress and a mean score of more than or equal to 3 is considered high stress.
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6 months
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Changes in insulin doses
Временное ограничение: 6 months
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Difference in number of recommended insulin dose adjustments per subject between intervention and usual care arm
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6 months
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Changes in reported hypoglycemia
Временное ограничение: 6 months
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Difference in the number of reported hypoglycemic events per subject between the intervention and usual care arm.
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6 months
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Time to achieve normoglycemia
Временное ограничение: 6 months
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Reduction in the time required to reach normoglycemia (in-range blood glucose readings) between the intervention and control groups.
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6 months
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Number of clinical interactions
Временное ограничение: 6 months
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• Differences in the number of clinical interactions per subjects with healthcare providers through the mobile app and through usual means in the standard care
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6 months
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Missed clinical appointments
Временное ограничение: 6 months
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Percent of missed clinical appointments in each arm.
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6 months
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Weight
Временное ограничение: 6 months
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Changes in weight from baseline at 6 months
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6 months
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Blood Pressure
Временное ограничение: 6 months
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Changes in blood pressure from baseline at 6 months
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6 months
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Lipids
Временное ограничение: 6 months
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Changes in lipids from baseline at 6 months
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6 months
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Другие показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
---|---|---|
Exploratory outcome
Временное ограничение: 6 months
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Increased mobile application usability by the system usability scale (SUS) at 6 months.
It consists of a 10 item questionnaire with five response options for respondents; from Strongly agree to Strongly disagree.
The participant's scores for each question are converted to a new number, added together and then multiplied by 2.5 to convert the original scores of 0-40 to 0-100.
An SUS score above a 68 would be considered above average and anything below 68 is below average, however the best way to interpret the results involves "normalizing" the scores to produce a percentile ranking
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6 months
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Exploratory outcome
Временное ограничение: 6 months
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Increased mobile application acceptance by documentation of patients experiences with the mobile application
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6 months
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Exploratory outcome
Временное ограничение: 6 months
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Reduction in hospital admissions
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6 months
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Соавторы и исследователи
Спонсор
Следователи
- Главный следователь: Noor N Suleiman, MD, Hamad Medical Corporation
Публикации и полезные ссылки
Общие публикации
- Kitsiou S, Pare G, Jaana M, Gerber B. Effectiveness of mHealth interventions for patients with diabetes: An overview of systematic reviews. PLoS One. 2017 Mar 1;12(3):e0173160. doi: 10.1371/journal.pone.0173160. eCollection 2017.
- Polonsky WH, Fisher L, Earles J, Dudl RJ, Lees J, Mullan J, Jackson RA. Assessing psychosocial distress in diabetes: development of the diabetes distress scale. Diabetes Care. 2005 Mar;28(3):626-31. doi: 10.2337/diacare.28.3.626.
- Bonoto BC, de Araujo VE, Godoi IP, de Lemos LL, Godman B, Bennie M, Diniz LM, Junior AA. Efficacy of Mobile Apps to Support the Care of Patients With Diabetes Mellitus: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. JMIR Mhealth Uhealth. 2017 Mar 1;5(3):e4. doi: 10.2196/mhealth.6309.
- Alotaibi MM, Istepanian R, Philip N. A mobile diabetes management and educational system for type-2 diabetics in Saudi Arabia (SAED). Mhealth. 2016 Aug 24;2:33. doi: 10.21037/mhealth.2016.08.01. eCollection 2016.
- Cui M, Wu X, Mao J, Wang X, Nie M. T2DM Self-Management via Smartphone Applications: A Systematic Review and Meta-Analysis. PLoS One. 2016 Nov 18;11(11):e0166718. doi: 10.1371/journal.pone.0166718. eCollection 2016.
- Seto E, Istepanian RS, Cafazzo JA, Logan A, Sungoor A. UK and Canadian perspectives of the effectiveness of mobile diabetes management systems. Annu Int Conf IEEE Eng Med Biol Soc. 2009;2009:6584-7. doi: 10.1109/IEMBS.2009.5333998.
- Istepanian RS, Zitouni K, Harry D, Moutosammy N, Sungoor A, Tang B, Earle KA. Evaluation of a mobile phone telemonitoring system for glycaemic control in patients with diabetes. J Telemed Telecare. 2009;15(3):125-8. doi: 10.1258/jtt.2009.003006.
- Ristau R, Yang J, White J. Evaluation and Evolution of Diabetes Mobile Applications: Key Factors for Health Care Professionals Seeking to Guide Patients.
- Alhuwail D. Diabetes Applications for Arabic Speakers: A Critical Review of Available Apps for Android and iOS Operated Smartphones. Stud Health Technol Inform. 2016;225:587-91.
- Schmitt A, Gahr A, Hermanns N, Kulzer B, Huber J, Haak T. The Diabetes Self-Management Questionnaire (DSMQ): development and evaluation of an instrument to assess diabetes self-care activities associated with glycaemic control. Health Qual Life Outcomes. 2013 Aug 13;11:138. doi: 10.1186/1477-7525-11-138.
- Suleiman N, Alkasem M, Al Amer Z, Salameh O, Al-Thani N, Hamad MK, Baagar K, Abdalhakam I, Othman M, Dughmosh R, Al-Mohanadi D, Al Sanousi A, Bashir M, Chagoury O, Taheri S, Abou-Samra AB. Qatar Diabetes Mobile Application Trial (QDMAT): an open-label randomised controlled trial to examine the impact of using a mobile application to improve diabetes care in type 2 diabetes mellitus-a study protocol. Trials. 2022 Jun 16;23(1):504. doi: 10.1186/s13063-022-06334-5.
Полезные ссылки
Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
Первичное завершение (Ожидаемый)
Завершение исследования (Ожидаемый)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
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
- 17292
Планирование данных отдельных участников (IPD)
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Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .
Клинические исследования Сахарный диабет 2 типа
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Trabzon Arakli Bayram Halil Public HospitalРекрутингДиабет Type2, ингибитор SGLT2, инфекция мочевыводящих путейТурция