- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT03998267
Qatar Diabetes Mobile Application Trial (QDMAT)
연구 개요
연구 유형
등록 (예상)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Noor N Suleiman, MD
- 전화번호: +97455816515
- 이메일: nsuleiman@hamad.qa
연구 연락처 백업
- 이름: Dabia H Al Mohanadi
- 전화번호: +97455524801
- 이메일: DAlMohanadi@hamad.qa
연구 장소
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Doha, 카타르
- 모병
- Hamad General Hospital
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연락하다:
- Noor Suleiman, MD
- 이메일: nsuleiman@hamad.qa
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 지지 요법
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
---|---|
활성 비교기: 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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위약 비교기: 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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Difference in mean HbA1c
기간: 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
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Subject perceptions of diabetes self management
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 6 months
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Changes in lipids from baseline at 6 months
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6 months
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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Exploratory outcome
기간: 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
기간: 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
기간: 6 months
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Reduction in hospital admissions
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6 months
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공동 작업자 및 조사자
수사관
- 수석 연구원: Noor N Suleiman, MD, Hamad Medical Corporation
간행물 및 유용한 링크
일반 간행물
- 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.
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (예상)
연구 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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