- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT00194558
Outcomes and Cost Consequences of Using an Internet Co-Management Module to Improve the Quality of Type 1 Diabetes Care
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
We will conduct a 12-month randomized controlled trial comparing usual care versus chronic disease management using the Internet among patients with type 1 diabetes on multiple daily injections with insulin glargine and rapid-acting analogs. Specifically, the objectives of the study are to:
- Evaluate the difference in glycemic control (HbA1c) between intervention and control,
- Evaluate the difference in resource utilization and costs of care between intervention and control, and
- Evaluate the difference in satisfaction with care between intervention and control.
A total of 80-85 subjects will be recruited from patients receiving care in the Diabetes Care Center (DCC) at the University of Washington in Seattle. As part of a pretest-posttest experimental design, intervention-group subjects will be trained in the use of an existing diabetes disease-management module comprising six related Web sites that are accessed from home via links displayed within the University's "MyUW" Internet portal. These sites allow patients to:
- View their entire electronic medical record including clinical reminders, the same record used by providers,
- Upload blood glucose readings stored in a digital meter,
- Manually enter medication, nutrition, and exercise data into an online daily diary,
- Communicate with providers regarding treatment recommendations or other questions using a clinical e-mail service,
- Obtain additional information from a traditional education site whose content and links were sanctioned by the Medical Director of the DCC, and
- Employ a second education site to collaboratively generate action plans intended to enhance self-efficacy.
In addition to login and password protection, access to confidential information from home requires the use of secondary authentication (SecureID). All clinical and other data can be viewed by patients and providers in online trended displays that will be used by a nurse practitioner to review cases no less than weekly. As the control group, subjects receiving usual care will not have access to the diabetes module and related case-management services being evaluated.
The primary clinical outcome for the study is the between group differences in glycemic control using HbA1c as the metric. A co-primary outcome is all direct medical care utilization. Satisfaction with diabetes care, employing both a quantitative survey (Patient Assessment of Chronic Illness Care) and semi-structured interviews performed on a 20% purposive sub-sample of intervention patients, is a secondary outcome measure.
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
Washington
-
Seattle, Washington, Förenta staterna, 98195
- University of Washington, Diabetes Care Center
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
- Computer and Internet access at home
- Receiving care at the University of Washington Diabetes Care Center
Exclusion Criteria:
- Non-English speaking
Studieplan
Hur är studien utformad?
Designdetaljer
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vad mäter studien?
Primära resultatmått
Resultatmått |
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Hemoglobin A1c
|
Sekundära resultatmått
Resultatmått |
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Utilization
|
Tillfredsställelse med vården
|
Samarbetspartners och utredare
Sponsor
Samarbetspartners
Utredare
- Huvudutredare: Harold I Goldberg, MD, University of Washington
Studieavstämningsdatum
Studera stora datum
Studiestart
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 04-3892-G-01
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