Denne siden ble automatisk oversatt og nøyaktigheten av oversettelsen er ikke garantert. Vennligst referer til engelsk versjon for en kildetekst.

Qatar Diabetes Mobile Application Trial (QDMAT)

12. februar 2020 oppdatert av: 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.

Studieoversikt

Status

Ukjent

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Forventet)

180

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studer Kontakt Backup

Studiesteder

  • Qatar
      • Doha, Qatar
        • Rekruttering
        • Hamad General Hospital
        • Ta kontakt med:

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 60 år (Voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Støttende omsorg
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Aktiv komparator: 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
Enhet: Droobi
A new mobile application, specifically built for the diabetes patients in Qatar with the help of local expertise.
Annen: Standard of care
Standard of care including physicians, dietetics and diabetes educators support
Placebo komparator: 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
Annen: Standard of care
Standard of care including physicians, dietetics and diabetes educators support

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Difference in mean HbA1c
Tidsramme: 6 months
Difference in mean HbA1C between the intervention arm and the standard care
6 months
Difference in mean HbA1c
Tidsramme: 3 months
Difference in mean HbA1C between the intervention arm and the standard care
3 months

Sekundære resultatmål

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

Andre resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Exploratory outcome
Tidsramme: 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
Tidsramme: 6 months
Increased mobile application acceptance by documentation of patients experiences with the mobile application
6 months
Exploratory outcome
Tidsramme: 6 months
Reduction in hospital admissions
6 months

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Hamad Medical Corporation

Samarbeidspartnere

Qatar Computing Research Institute (QCRI)
Droobi Health

Etterforskere

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

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Hjelpsomme linker

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

22. august 2019

Primær fullføring (Forventet)

17. august 2020

Studiet fullført (Forventet)

31. desember 2020

Datoer for studieregistrering

Først innsendt

11. juni 2019

Først innsendt som oppfylte QC-kriteriene

23. juni 2019

Først lagt ut (Faktiske)

26. juni 2019

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

17. februar 2020

Siste oppdatering sendt inn som oppfylte QC-kriteriene

12. februar 2020

Sist bekreftet

1. februar 2020

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 17292

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Kliniske studier på Type 2 diabetes mellitus

Søk i lignende forsøk

Sponsorer og samarbeidspartnere

Medisinsk tilstand

Legemiddelintervensjoner

CROs by country

CROs in Guatemala

Forhold

Sjeldne sykdommer

Legemiddelintervensjoner

Kosttilskudd

Sponsor / samarbeidspartnere

Steder

3
Abonnere