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Qatar Diabetes Mobile Application Trial (QDMAT)

12 février 2020 mis à jour par: 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.

Aperçu de l'étude

Statut

Inconnue

Les conditions

Intervention / Traitement

Type d'étude

Interventionnel

Inscription (Anticipé)

180

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans à 60 ans (Adulte)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

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.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Soins de soutien
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Comparateur actif: Intervention arm

For the subjects using the app (intervention group): The mobile app team shall do the following:

  • Educate/train patients on app usage
  • Patients will be subscribed to the app and their profile on the app will be created
  • Subjects will log in their blood sugar readings and communicate with the mobile app team (educators and physician) via the app
  • Additionally patients will be placed on a diet and lifestyle plan as agreed upon by the patient and health care provider team, best suited towards the patient's needs
  • Throughout the study, patient will receive notifications and advice on how to follow diet and lifestyle changes
  • Throughout the study; patient interaction and app usage will be tracked
  • Patients will additionally be interviewed by the research team together with Droobi to capture app experience at 3 months and 6 months
Dispositif: Droobi
A new mobile application, specifically built for the diabetes patients in Qatar with the help of local expertise.
Autre: Standard of care
Standard of care including physicians, dietetics and diabetes educators support
Comparateur placebo: Standard of care arm

For the subjects not using the app (the standard of care group):

  • At time 0, will be seen by the dietician and diabetes educators at HGH endocrine clinics as part of standards of care

  • The educators contact number and diabetes hotline number will be provided to the patients

    o The diabetes hotline number #16099 is a new service provided to diabetes patients at the national diabetes center to help communicate with the diabetes educators with questions relating to their diabetes management, medication adjustment such as dose titrations etc.

  • Appointments thereafter with the educator and/or dietician will be decided and scheduled according to the individual patient needs, with a minimum visit every 3 months during the study period
Autre: Standard of care
Standard of care including physicians, dietetics and diabetes educators support

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Difference in mean HbA1c
Délai: 6 months
Difference in mean HbA1C between the intervention arm and the standard care
6 months
Difference in mean HbA1c
Délai: 3 months
Difference in mean HbA1C between the intervention arm and the standard care
3 months

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Subject perceptions of diabetes self management
Délai: 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
6 months
Change in subjects attitudes towards disease
Délai: 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
Changes in insulin doses
Délai: 6 months
Difference in number of recommended insulin dose adjustments per subject between intervention and usual care arm
6 months
Changes in reported hypoglycemia
Délai: 6 months
Difference in the number of reported hypoglycemic events per subject between the intervention and usual care arm.
6 months
Time to achieve normoglycemia
Délai: 6 months
Reduction in the time required to reach normoglycemia (in-range blood glucose readings) between the intervention and control groups.
6 months
Number of clinical interactions
Délai: 6 months
• Differences in the number of clinical interactions per subjects with healthcare providers through the mobile app and through usual means in the standard care
6 months
Missed clinical appointments
Délai: 6 months
Percent of missed clinical appointments in each arm.
6 months
Weight
Délai: 6 months
Changes in weight from baseline at 6 months
6 months
Blood Pressure
Délai: 6 months
Changes in blood pressure from baseline at 6 months
6 months
Lipids
Délai: 6 months
Changes in lipids from baseline at 6 months
6 months

Autres mesures de résultats

Mesure des résultats
Description de la mesure
Délai
Exploratory outcome
Délai: 6 months
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
6 months
Exploratory outcome
Délai: 6 months
Increased mobile application acceptance by documentation of patients experiences with the mobile application
6 months
Exploratory outcome
Délai: 6 months
Reduction in hospital admissions
6 months

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Hamad Medical Corporation

Collaborateurs

Qatar Computing Research Institute (QCRI)
Droobi Health

Les enquêteurs

  • Chercheur principal: Noor N Suleiman, MD, Hamad Medical Corporation

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Liens utiles

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

22 août 2019

Achèvement primaire (Anticipé)

17 août 2020

Achèvement de l'étude (Anticipé)

31 décembre 2020

Dates d'inscription aux études

Première soumission

11 juin 2019

Première soumission répondant aux critères de contrôle qualité

23 juin 2019

Première publication (Réel)

26 juin 2019

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

17 février 2020

Dernière mise à jour soumise répondant aux critères de contrôle qualité

12 février 2020

Dernière vérification

1 février 2020

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • 17292

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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