A 6-month Clinical Study to Evaluate the Effect of a Digital Disease Management Tool in Patients With T2DM
8. mai 2019 oppdatert av: AstraZeneca
A Real-world, Point-of-care, Randomized, Parallel Group, Open, 6-month Clinical Study to Evaluate the Effect of a Digital Disease Management Tool in Patients With Type 2 Diabetes Mellitus
Type 2 diabetes mellitus is a complex, chronic disease that requires a comprehensive treatment plan aimed at meeting multitude therapeutic targets associated with micro- and macro-vascular risk reduction.
There is evidence that patient support in various forms can have a significant positive impact on adherence to treatment and the meeting of targets in patients with type 2 diabetes mellitus.
The purpose of this study is to evaluate if the use of a digital disease management tool (Smart phone- web portal-based tool), in addition to Standard of Care for T2DM, will improve glycemic control.
Other variables important in T2DM (such as weight, blood pressure, and lipid levels), will also be evaluated along with patient-reported outcomes, such as satisfaction with treatment and adherence to their antihyperglycemic treatment.
Study duration is 6 months
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
Type 2 diabetes mellitus (T2DM) is a complex, chronic disease that requires a comprehensive treatment plan aimed at meeting multitude therapeutic targets associated with micro- and macro-vascular risk reduction. There is evidence that patient support in various forms can have a significant positive impact on adherence to treatment and the meeting of targets in patients with type 2 diabetes mellitus. A digital disease-management tool, smart phone- and web-based portal, has been developed that incorporates the following features aimed at improving patient and population outcomes:
Treatment management to help patients remember to take medications and track adherence; Goal setting, including medical nutrition therapy, appropriately prescribed physical activity, and weight loss for those patients who are overweight or obese; Tracking and data collection for blood glucose, weight, and exercise, as entered by the patient or automatically for activity via Bluetooth pedometer or activity tracker; Assessments to capture patient beliefs in order to tailor personalized content to individual needs; educational and motivational content in the form of short messages, text, and videos covering T2DM and its treatment, and lifestyle advice; Web portals to display collected data back to the patient and healthcare practitioner in real-time to allow better and timely management of diabetes.
This tool is added to the Standard of Care for T2DM. Data are collected for patients utilizing this tool, compared with those who are not. Clinical assessments as part of the Standard of Care are collected, as well as standard Patient Reported Outcomes for this disease.
Glycemic control is considered to be the goal of a T2DM disease management plan.
Studietype
Observasjonsmessig
Registrering (Faktiske)
328
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Alabama
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Birmingham, Alabama, Forente stater, 35209
- Research Site
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Birmingham, Alabama, Forente stater, 35216
- Research Site
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Arizona
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Peoria, Arizona, Forente stater, 85381
- Research Site
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Surprise, Arizona, Forente stater, 85374
- Research Site
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California
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Lincoln, California, Forente stater, 95648
- Research Site
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Montclair, California, Forente stater, 91763
- Resezrch Site
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North Hollywood, California, Forente stater, 91606
- Research Site
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Spring Valley, California, Forente stater, 91978
- Research Site
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Van Nuys, California, Forente stater, 91405
- Research Site
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Colorado
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Colorado Springs, Colorado, Forente stater, 80906
- Research Site
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Florida
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Cooper City, Florida, Forente stater, 33024
- Research Site
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DeLand, Florida, Forente stater, 32720
- Research Site
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Hialeah, Florida, Forente stater, 33012
- Research Site
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Jacksonville, Florida, Forente stater, 32277
- Reserarch Site
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Lake City, Florida, Forente stater, 32055
- Research Site
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Ormond Beach, Florida, Forente stater, 32174
- Research Site
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Pembroke Pines, Florida, Forente stater, 33026
- Research Site
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Port Orange, Florida, Forente stater, 32127
- Research Site
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Tampa, Florida, Forente stater, 33634
- Research Site
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Illinois
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Evanston, Illinois, Forente stater, 60201
- Research Site
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Kentucky
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Lexington, Kentucky, Forente stater, 40503
- Research Site
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Maryland
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Oxon Hill, Maryland, Forente stater, 20745
- Research Site
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Nebraska
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Omaha, Nebraska, Forente stater, 68134
- Research Site
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Nevada
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Las Vegas, Nevada, Forente stater, 89128
- Research Site
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New Mexico
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Albuquerque, New Mexico, Forente stater, 87102
- Research Site
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New York
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Brooklyn, New York, Forente stater, 11235
- Research Site
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New Windsor, New York, Forente stater, 12553
- Research Site
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Westfield, New York, Forente stater, 14787
- Research Site
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North Carolina
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Greensboro, North Carolina, Forente stater, 27410
- Research Site
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Ohio
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Franklin, Ohio, Forente stater, 45005
- Research Site
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Pennsylvania
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Downingtown, Pennsylvania, Forente stater, 19335
- Research Site
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South Carolina
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Charleston, South Carolina, Forente stater, 29407
- Research Site
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Greer, South Carolina, Forente stater, 29651
- Research Site
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Myrtle Beach, South Carolina, Forente stater, 29588
- Research Site
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Spartanburg, South Carolina, Forente stater, 29301
- Research Site
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Tennessee
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Tullahoma, Tennessee, Forente stater, 37388
- Research Site
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Texas
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Houston, Texas, Forente stater, 77058
- Research Site
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Houston, Texas, Forente stater, 77040
- Research Site
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Lampasas, Texas, Forente stater, 76550
- Research Site
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Plano, Texas, Forente stater, 75024
- Research Site
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Utah
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Salt Lake City, Utah, Forente stater, 84107
- Research Site
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Virginia
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Burke, Virginia, Forente stater, 22015
- Research Site
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Manassas, Virginia, Forente stater, 20110
- Research Site
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Richmond, Virginia, Forente stater, 23235
- Research Site
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Washington
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Federal Way, Washington, Forente stater, 98003
- Research Site
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Olympia, Washington, Forente stater, 98502
- Research Site
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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 99 år (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Prøvetakingsmetode
Sannsynlighetsprøve
Studiepopulasjon
Patients with Type 2 diabetes mellitus who are on 1 or more non-insulin antihyperglycemic medications for at least 6 months prior to enrollment.
Beskrivelse
Inclusion Criteria:
- Provision of written informed consent;
- Diagnosed with T2DM;
- Male or female aged >/= 18 years at time of consent;
- Treatment with 1 or more non-insulin antihyperglycemic medications for at least 6 months prior to enrollment;
- Own or have access to a smart phone with internet access and have access to the internet via a tablet or personal computer at least once a day;
- HbA1c levels must be obtained at the enrollment visit or up to 14 days prior to Visit 1 and must be >/=7.5% and </=11.0%. Most of the hbA1c values obtained within the past 9 months must also be within this range;
- Body mass index >/= 25 and </=55 kg/mm2 within the last 3 months;
- Ability to communicate in English;
- Judged by their primary care physician to have suitable hearing, vision, manual dexterity, ability to understand instructions, and ability to use and understand smart phone and internet applications;
- Negative pregnancy test for female subjects of childbearing potential.
Exclusion Criteria:
- Pregnancy;
- Insulin use at baseline;
- Current use of a smart phone- or web portal-based tool designed to help with management of T2DM;
- History of Type 1 diabetes or ketoacidosis;
- Currently taking weight loss medication;
- Involvement in the planning and/or conduct of this study;
- Previous enrollment in the present study;
- Participation in a clinical study with an investigational product or a disease state management program during the last 30 days;
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
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Standard of Care (SOC)
Participants have standard of care with no access to digital disease management tool
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SOC + digital disease management
Participants have access to the digital disease management tool in addition to standard of care
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The purpose of the study is to evaluate if the provision of a digital disease management tool, in addition to SOC for T2DM, will improve glycemic control.
The impact of the tool will be assessed in comparison to a Control group who will receive SOC alone.
All participants will complete the PRO assessments.
This is a real world study carried out at the point of care.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Change from baseline to end of study (Month 6) in HbA1c levels
Tidsramme: 6 months
|
Assessed from blood samples taken at visits per standard of care
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6 months
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Percentage of patients who achieve HbA1c levels <7% at Month 6
Tidsramme: 6 Months
|
Assessed from blood samples taken at visits per standard of care
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6 Months
|
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Mean change in body weight (kg) from baseline to Month 6
Tidsramme: 6 Months
|
Measures taken at visits per standard of care
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6 Months
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Proportion of patients in both cohorts who intensify antihyperglycemic treatment from Visit 1
Tidsramme: 6 Months
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Defined as an increase in dose or addition of a new antihyperglycemic agent not received at baseline
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6 Months
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Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Number of times the smart phone- and/or web portal-based tool is accessed per patient
Tidsramme: 6 Months
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Calculated by adding the total number of discrete log-in attempts to the tool for each patient using the tool at least once
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6 Months
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Length of time from first to last usage of smart phone- and/or web portal-based tool across the course of the study
Tidsramme: 6 Months
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Determined by calculating the time from first to last log-in attempt for each patient accessing the tool at least twice during the course of the study
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6 Months
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Mean patient satisfaction with the digital disease management tool
Tidsramme: 6 Months
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Assessed by the User Satisfaction Survey
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6 Months
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Mean percent change from baseline to Month 6 in systolic blood pressure
Tidsramme: 6 Months
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Measures taken at visits per standard of care
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6 Months
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Mean percent change from baseline to Month 6 in low-density lipoprotein-cholesterol (LDL-C)
Tidsramme: 6 Months
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Assessed from blood samples taken at visits per standard of care
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6 Months
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Percent of patients who achieve blood pressure <140/90 mmHg at Month 6
Tidsramme: 6 Months
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Measures taken at visits per standard of care
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6 Months
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Percent of patients who achieve LDL-C <100 mg/dL at Month 6
Tidsramme: 6 Months
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Assessed from blood samples taken at visits per standard of care
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6 Months
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Differences in primary care office visits between active and control group during the 6-month study period
Tidsramme: 6 Months
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As reported in patient records
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6 Months
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Differences in Emergency Room visits between active and control group during the 6-month study period as reported in patients at the end of the study
Tidsramme: 6 Months
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As reported by patients at the end of the study
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6 Months
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Change in baseline to Month 6 in Diabetes Treatment Satisfaction Questionnaire - Status version score
Tidsramme: 6 Months
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As assessed in the Patient Reported Outcome measure Diabetes Treatment Satisfaction Questionnaire - Status version at the point-of-care visits
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6 Months
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Change in baseline to Month 6 in Diabetes Self-Management Questionnaire score (16-question) (patient perception on ability to manage their disease)
Tidsramme: 6 Months
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As assessed in the Patient Reported Outcomes measure Diabetes Self-Management Questionnaire at the point-of-care visits
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6 Months
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Change in baseline to Month 6 in Morisky Medication Adherence Scale (8-item) (adherence)
Tidsramme: 6 Months
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As assessed in the Patient Reported Outcome measure Morisky Medication Adherence Scale at the point-of-care visits
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6 Months
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Studiestol: Kevin Sooben, AstraZeneca
Publikasjoner og nyttige lenker
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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)
8. mai 2017
Primær fullføring (Faktiske)
21. mai 2018
Studiet fullført (Faktiske)
21. mai 2018
Datoer for studieregistrering
Først innsendt
20. mars 2017
Først innsendt som oppfylte QC-kriteriene
20. mars 2017
Først lagt ut (Faktiske)
24. mars 2017
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
9. mai 2019
Siste oppdatering sendt inn som oppfylte QC-kriteriene
8. mai 2019
Sist bekreftet
1. mai 2019
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- D1841C00004
Plan for individuelle deltakerdata (IPD)
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