Qatar Diabetes Mobile Application Trial (QDMAT)
2020年2月12日 更新者：Hamad Medical Corporation
Diabetes mobile technology is an emerging and rapidly expanding field that seeks to combine cutting edge behavioral insights with best practice in diabetes self management education to improve patient empowerment and deliver better patient outcomes.The question that arises is whether or not, diabetes mobile applications are effective in improving glycemic control, clinical outcomes, quality of life and overall patient satisfaction, in diabetic patients in Qatar.
To answer this, we plan to enroll 90 diabetic patients into a custom-made diabetes app for Qatar (Droobi) (as intervention group) in comparison with 90 diabetic patients followed in the current standard care, matched in characteristics (as control group).
We have the hypothesis that with utilization of the mobile application, patients will have improved glycemic control, improved self management and patient empowerment; together with improved patient-educator/doctor interaction.
調査の概要
研究の種類
介入
入学 (予想される)
180
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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Doha、カタール
- 募集
- Hamad General Hospital
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コンタクト：
- Noor Suleiman, MD
- メール：nsuleiman@hamad.qa
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年～60年 (大人)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
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.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：支持療法
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
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アクティブコンパレータ：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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プラセボコンパレーター：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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Difference in mean HbA1c
時間枠：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
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Subject perceptions of diabetes self management
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：6 months
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Changes in lipids from baseline at 6 months
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6 months
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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Exploratory outcome
時間枠：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
時間枠：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
時間枠：6 months
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Reduction in hospital admissions
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6 months
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
捜査官
- 主任研究者：Noor N Suleiman, MD、Hamad Medical Corporation
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
一般刊行物
- 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.
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2019年8月22日
一次修了 (予想される)
2020年8月17日
研究の完了 (予想される)
2020年12月31日
試験登録日
最初に提出
2019年6月11日
QC基準を満たした最初の提出物
2019年6月23日
最初の投稿 (実際)
2019年6月26日
学習記録の更新
投稿された最後の更新 (実際)
2020年2月17日
QC基準を満たした最後の更新が送信されました
2020年2月12日
最終確認日
2020年2月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
2型糖尿病の臨床試験
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National Human Genome Research Institute (NHGRI)完了