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- Ensaio Clínico NCT03998267
Qatar Diabetes Mobile Application Trial (QDMAT)
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Tipo de estudo
Inscrição (Antecipado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: Noor N Suleiman, MD
- Número de telefone: +97455816515
- E-mail: nsuleiman@hamad.qa
Estude backup de contato
- Nome: Dabia H Al Mohanadi
- Número de telefone: +97455524801
- E-mail: DAlMohanadi@hamad.qa
Locais de estudo
-
-
-
Doha, Catar
- Recrutamento
- Hamad General Hospital
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Contato:
- Noor Suleiman, MD
- E-mail: nsuleiman@hamad.qa
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
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.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Cuidados de suporte
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
---|---|
Comparador Ativo: Intervention arm
For the subjects using the app (intervention group): The mobile app team shall do the following:
|
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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Comparador de Placebo: 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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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Difference in mean HbA1c
Prazo: 6 months
|
Difference in mean HbA1C between the intervention arm and the standard care
|
6 months
|
Difference in mean HbA1c
Prazo: 3 months
|
Difference in mean HbA1C between the intervention arm and the standard care
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3 months
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Subject perceptions of diabetes self management
Prazo: 6 months
|
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
Prazo: 6 months
|
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.
|
6 months
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Changes in insulin doses
Prazo: 6 months
|
Difference in number of recommended insulin dose adjustments per subject between intervention and usual care arm
|
6 months
|
Changes in reported hypoglycemia
Prazo: 6 months
|
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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 6 months
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Changes in blood pressure from baseline at 6 months
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6 months
|
Lipids
Prazo: 6 months
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Changes in lipids from baseline at 6 months
|
6 months
|
Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Exploratory outcome
Prazo: 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
|
Exploratory outcome
Prazo: 6 months
|
Increased mobile application acceptance by documentation of patients experiences with the mobile application
|
6 months
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Exploratory outcome
Prazo: 6 months
|
Reduction in hospital admissions
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6 months
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Noor N Suleiman, MD, Hamad Medical Corporation
Publicações e links úteis
Publicações Gerais
- 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.
Links úteis
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Antecipado)
Conclusão do estudo (Antecipado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 17292
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