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T2DXcel Mobile Application (T2DXcel)

17 augustus 2022 bijgewerkt door: Sunit P. Jariwala, Montefiore Medical Center

Developing and Evaluating the T2DXcel Mobile Application for Adult Patients With Type 2 Diabetes

Given the need for personalizable and adaptive mobile applications for patients with type 2 diabetes, this proposal will develop, evaluate, and refine a patient-centered mobile application (T2DXcel), which will deliver tailored and algorithm-based diabetes education to improve process and diabetes-related outcomes.

Studie Overzicht

Toestand

Voltooid

Interventie / Behandeling

Gedetailleerde beschrijving

The Bronx has the heaviest burden of diabetes within New York City (NYC) and statewide. The highest diabetes hospitalization and death rates in NYC occur in the Bronx, which has hospitalization rates approximately 25 percent above the statewide average. The Bronx is one of the poorest urban counties in the nation, and diabetes disproportionately impacts high-poverty communities. The borough has an ethnically and racially diverse population (53.5% of residents are Hispanic and 36.5% are black), and diabetes is highly prevalent among blacks and Hispanics. Obesity, a major risk factor for diabetes, is also prevalent with nearly 33% (much higher than the 24% prevalence of obesity in NYC) of Bronx adults being obese. Among the many social determinants of health, medical provider practice behaviors, suboptimal access to health care, lack of patient knowledge regarding proper medication administration and potential side effects, and difficulty adhering to medical regimens by patients and families all contribute to poor diabetes outcomes.

With appropriate medical care including education (especially regarding potentially modifiable lifestyle factors that contribute to diabetes), well-informed patients can achieve diabetes control. However, there are significant challenges in providing effective patient education in the ambulatory setting, such as time constraints and prioritizing other issues (e.g. comorbid conditions) above comprehensive diabetes education. While patient education and teaching self-management skills are critical to improve diabetes outcomes, such strategies will succeed only as part of more comprehensive interventions. Diabetes self-management education (DSME) has been linked to decreases in hemoglobin A1c, reductions in the onset and/or progression of diabetes complications, reductions in diabetes-related hospitalizations and readmissions, and improvements in quality of life, lifestyle behaviors (e.g. physical activity, healthier eating), self-efficacy, and coping skills. The American Association of Diabetes Educators (AADE) has described the AADE7 Self-Care Behaviors (healthy eating, being active, monitoring, taking medications, problem solving, healthy coping, reducing risks) as a framework to organize and structure patient-centered education. Despite the proven benefits of DSME, less than 10% of type 2 diabetes (T2D) patients receive structured education for a variety of reasons: providers' misunderstanding of DSME effectiveness and confusion about how to make referrals; many clinic sites' lack of access to DSME services; and some payers' lack of coverage for DSME services. With the increasing use of smartphones and the internet, health information technology (IT)-based approaches (e.g. mobile applications, text messaging platforms, internet-based educational modules, and telemedicine/telehealth interventions) - through standalone interventions or by supplementing education (i.e. by reinforcing content delivered in-person) - can increase patients' access to DSME, and have been linked to improvements in hemoglobin A1c and other outcomes. Mobile applications ('apps') can provide day-to-day support for patients with diabetes, but commonly lack evidence-based content and/or comprehensiveness. A recent study reported that only a small percentage of the diabetes apps available on the iOS and Android stores supported the AADE7 behaviors regarding problem solving, healthy coping, and reducing risks. Another recent article suggested that few apps provided personalized education or tailored therapeutic support. As with other chronic conditions, diabetes mobile applications are often characterized by low retention rates and decreased user engagement with the app following the initial download.

Given the need for personalizable and adaptive mobile applications for patients with type 2 diabetes, this proposal will develop, evaluate, and refine a patient-centered mobile application (T2DXcel), which will deliver tailored and algorithm-based diabetes education to improve process and diabetes-related outcomes.

Studietype

Ingrijpend

Inschrijving (Werkelijk)

55

Fase

  • Fase 2
  • Fase 1

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

    • New York
      • Bronx, New York, Verenigde Staten, 10467
        • Montefiore Medical Center

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 en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

Inclusion Criteria:

English-speaking individuals >18 years with:

  1. T2D (diagnosis made by a healthcare provider) on an anti-diabetic medication with hemoglobin A1c > 6.5% at the time of recruitment and enrollment
  2. Diabetes care at Montefiore
  3. Able to give informed consent; and d) smartphone (iOS or Android) access

Exclusion Criteria:

  1. Pregnancy
  2. Chronic illness with organ failure (heart failure, severe liver disease, chronic kidney disease stage 3-4 or dialysis) or requiring chemotherapy or steroid use
  3. Severe psychiatric or cognitive problems that would prohibit an individual from completing the protocol

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: Onderzoek naar gezondheidsdiensten
  • Toewijzing: NVT
  • Interventioneel model: Opdracht voor een enkele groep
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Ander: T2DXcel mobile application
T2DXcel is a mobile application (patient-facing) that delivers guideline-based diabetes education.
T2DXcel is a mobile application (patient-facing) that delivers guideline-based diabetes education.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change from baseline hemoglobin A1c to 3 and 6 months
Tijdsspanne: Baseline, 3 months, 6 months
Patients' glycemic control measured by hemoglobin A1c
Baseline, 3 months, 6 months

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Patient satisfaction measured by the Client Satisfaction Questionnaire-8
Tijdsspanne: Baseline, 3 months, 6 months
Patient satisfaction measured by the Client Satisfaction Questionnaire-8
Baseline, 3 months, 6 months
Change from baseline diabetes knowledge to 3 months and 6 months
Tijdsspanne: Baseline, 3 months, 6 months
Diabetes knowledge as measured by the validated Diabetes Knowledge Questionnaire-24
Baseline, 3 months, 6 months
Change from baseline diabetes self-management capabilities to 3 months and 6 months
Tijdsspanne: Baseline, 3 months, 6 months
Diabetes self-management capabilities as measured by the Diabetes Self-Management Questionnaire
Baseline, 3 months, 6 months
Change from baseline diabetes self-efficacy to 3 months and 6 months
Tijdsspanne: Baseline, 3 months, 6 months
Diabetes self-efficacy as measured by the Diabetes Empowerment Scale-Short Form
Baseline, 3 months, 6 months
Change from baseline diabetes quality of life to 3 months and 6 months
Tijdsspanne: Baseline, 3 months, 6 months
Patients' diabetes quality of life measured by the Diabetes Quality of Life questionnaire
Baseline, 3 months, 6 months
Change from baseline LDL cholesterol to 3 months and 6 months
Tijdsspanne: Baseline, 3 months, 6 months
LDL cholesterol
Baseline, 3 months, 6 months

Medewerkers en onderzoekers

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

Onderzoekers

  • Hoofdonderzoeker: Sunit Jariwala, MD, Albert Einstein College of Medicine and Montefiore Medical Center

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)

1 maart 2020

Primaire voltooiing (Werkelijk)

1 juli 2022

Studie voltooiing (Werkelijk)

1 juli 2022

Studieregistratiedata

Eerst ingediend

23 maart 2019

Eerst ingediend dat voldeed aan de QC-criteria

23 maart 2019

Eerst geplaatst (Werkelijk)

26 maart 2019

Updates van studierecords

Laatste update geplaatst (Werkelijk)

18 augustus 2022

Laatste update ingediend die voldeed aan QC-criteria

17 augustus 2022

Laatst geverifieerd

1 augustus 2022

Meer informatie

Termen gerelateerd aan deze studie

Andere studie-ID-nummers

  • 2018-9590

Plan Individuele Deelnemersgegevens (IPD)

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

NEE

Beschrijving IPD-plan

Only aggregated and de-identified datasets will be shared with other researchers.

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

Klinische onderzoeken op Diabetes mellitus, type 2

Klinische onderzoeken op T2DXcel mobile application

3
Abonneren