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Qatar Diabetes Mobile Application Trial (QDMAT)

12 februari 2020 bijgewerkt door: 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.

Studie Overzicht

Toestand

Onbekend

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Verwacht)

180

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar tot 60 jaar (Volwassen)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Ondersteunende zorg
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Actieve vergelijker: 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
Apparaat: Droobi
A new mobile application, specifically built for the diabetes patients in Qatar with the help of local expertise.
Ander: Standard of care
Standard of care including physicians, dietetics and diabetes educators support
Placebo-vergelijker: 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
Ander: Standard of care
Standard of care including physicians, dietetics and diabetes educators support

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Difference in mean HbA1c
Tijdsspanne: 6 months
Difference in mean HbA1C between the intervention arm and the standard care
6 months
Difference in mean HbA1c
Tijdsspanne: 3 months
Difference in mean HbA1C between the intervention arm and the standard care
3 months

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Subject perceptions of diabetes self management
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 6 months
Difference in number of recommended insulin dose adjustments per subject between intervention and usual care arm
6 months
Changes in reported hypoglycemia
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 6 months
Percent of missed clinical appointments in each arm.
6 months
Weight
Tijdsspanne: 6 months
Changes in weight from baseline at 6 months
6 months
Blood Pressure
Tijdsspanne: 6 months
Changes in blood pressure from baseline at 6 months
6 months
Lipids
Tijdsspanne: 6 months
Changes in lipids from baseline at 6 months
6 months

Andere uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Exploratory outcome
Tijdsspanne: 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
Tijdsspanne: 6 months
Increased mobile application acceptance by documentation of patients experiences with the mobile application
6 months
Exploratory outcome
Tijdsspanne: 6 months
Reduction in hospital admissions
6 months

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Hamad Medical Corporation

Medewerkers

Qatar Computing Research Institute (QCRI)
Droobi Health

Onderzoekers

  • Hoofdonderzoeker: Noor N Suleiman, MD, Hamad Medical Corporation

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Nuttige links

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

22 augustus 2019

Primaire voltooiing (Verwacht)

17 augustus 2020

Studie voltooiing (Verwacht)

31 december 2020

Studieregistratiedata

Eerst ingediend

11 juni 2019

Eerst ingediend dat voldeed aan de QC-criteria

23 juni 2019

Eerst geplaatst (Werkelijk)

26 juni 2019

Updates van studierecords

Laatste update geplaatst (Werkelijk)

17 februari 2020

Laatste update ingediend die voldeed aan QC-criteria

12 februari 2020

Laatst geverifieerd

1 februari 2020

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 17292

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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