Determining the Effect on Patients of Internet-Based Diabetes Disease Management
| Tracking Information | |||||
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| First Received Date ICMJE | September 15, 2005 | ||||
| Last Updated Date | July 31, 2007 | ||||
| Start Date ICMJE | September 2003 | ||||
| Primary Completion Date | Not Provided | ||||
| Current Primary Outcome Measures ICMJE |
Hemoglobin A1c | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00220207 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Determining the Effect on Patients of Internet-Based Diabetes Disease Management | ||||
| Official Title ICMJE | A Randomized Controlled Trial of Diabetes Disease Management Over the Internet | ||||
| Brief Summary | This grant supports a 12-month randomized controlled trial comparing usual care versus collaborative disease management over the Internet among disadvantaged African-Americans with Type 2 diabetes. The project aims to: (1) determine the effect of case-managed, Web-based diabetes care on glycemic control, health care utilization, self-efficacy, and patient satisfaction; and (2) qualitatively identify enablers of the successful use of computers, the Internet, and e-Health applications by disadvantaged patients. |
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| Detailed Description | We propose to conduct a 12-month randomized controlled trial comparing usual care versus chronic disease management over the Internet among disadvantaged African-Americans with type 2 diabetes. Subjects will be recruited from patients receiving primary care at Harborview Medical Center, the County facility administered by the University of Washington in Seattle. As part of a pretest-posttest experimental design, 30 intervention subjects will be trained to use an existing diabetes disease-management module comprising six Web sites that are accessed from home via links displayed within the University's "MyUW" Internet portal. These sites allow patients to:
All data can be viewed by patients and providers in online trended displays that a clinical pharmacist will use to review cases no less often than weekly. As an attention control, 30 subjects will also be trained to use a provided personal computer to access Internet knowledge resources, but will not have access to the case-management services and module being evaluated. By comparing the two groups, we aim to:
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE | Diabetes Mellitus, Type 2 | ||||
| Intervention ICMJE | Behavioral: Internet co-management module | ||||
| Study Arm (s) | Not Provided | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 63 | ||||
| Completion Date | February 2007 | ||||
| Primary Completion Date | Not Provided | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years to 75 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00220207 | ||||
| Other Study ID Numbers ICMJE | 49154 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Not Provided | ||||
| Study Sponsor ICMJE | Robert Wood Johnson Foundation | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Robert Wood Johnson Foundation | ||||
| Verification Date | July 2007 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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