- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00194506
Cyber Disease Management: Using the World Wide Web to Share the Medical Record With Patients at Home
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
We will conduct a randomized controlled trial to determine whether a fully computerized, diabetes mellitus (DM) disease-management module (known as Cyber-DM) can improve the quality of adult diabetes care. The module will be Web-based, include a graphical HTML "front end" user interface, and will be incorporated into each patient's existing Web-based electronic medical record --the Medical Information Networked Database (MIND) repository at the University of Washington Academic Medical Centers. This Web site will include five components that will enable patients to interact asynchronously from their homes with their clinic-based providers:
- An integrated view of their actual medical record as it relates to diabetes care that can generate customized patient education materials.
- Real-time clinical reminders of the need to obtain preventive services such as HbA1c, urine-protein and cholesterol determinations, and retinal examinations.
- An electronic version of the SDMTM diabetes-care algorithms indicating where on the "road-map" to adequate control they currently stand treatment-wise.
- The ability to download glucometer readings and medication-use information from home directly into the MIND repository.
- Secure email communication between patients, their primary care physicians, and clinic staff.
A total of 80-85 diabetic patients who are regular utilizers of the UW's General Internal Medicine Clinic and who have home Internet access will be randomized to the experimental and control arms of the trial. Control subjects will receive usual care. We hypothesize that use of Cyber-DM will increase compliance with guideline-indicated care processes, improve glycemic control, and reduce utilization costs. A trial this size would have the statistical power to detect a change in HbA1c of 0.50%. Secure Socket Layer technology, session specific "cookie" files, and a custom database application that manages logins/passwords and audits all accesses to the system will provide security for this information tool.
Undersøgelsestype
Tilmelding
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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Washington
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Seattle, Washington, Forenede Stater, 98195
- University of Washington, General Internal Medicine Clinic, Roosevelt
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- computer and Internet access at home
- receiving care for type 2 diabetes at the University of Washington, General Internal Medicine Clinic, Roosevelt
Exclusion Criteria:
- non-English speaking
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Uddannelse/Rådgivning/Træning
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
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Hæmoglobin A1c
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Sekundære resultatmål
Resultatmål |
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Utilization
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Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Harold I. Goldberg, MD, University of Washington
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart
Studieafslutning
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 00-3882-E/A 05
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