Internet-based Diabetes Education and Case Management
Tracking Information | |||||
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First Received Date ICMJE | March 17, 2005 | ||||
Last Updated Date | August 1, 2012 | ||||
Start Date ICMJE | February 2005 | ||||
Primary Completion Date | April 2007 (final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Change in HbA1c at 12 months [ Time Frame: 12 months ] [ Designated as safety issue: No ] | ||||
Original Primary Outcome Measures ICMJE |
Clinical data (e.g., HbA1c, blood pressure, quality of life questionnaires) | ||||
Change History | Complete list of historical versions of study NCT00105898 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures ICMJE |
Change in blood pressure, lipid profile and diabetes-related stress (self-report) at 12 months; cost-effectiveness analysis of the interventions. [ Time Frame: 12 months ] [ Designated as safety issue: No ] | ||||
Original Secondary Outcome Measures ICMJE |
Economic data (e.g., costs of case management, medication usage, and number(s) of ER visits/hospitalizations during the study period) | ||||
Current Other Outcome Measures ICMJE | |||||
Original Other Outcome Measures ICMJE | |||||
Descriptive Information | |||||
Brief Title ICMJE | Internet-based Diabetes Education and Case Management | ||||
Official Title ICMJE | Internet-based Diabetes Education and Case Management | ||||
Brief Summary | This study is comparing the effectiveness of web-based care management to either telephone-based care management or internet access alone, in patients with poorly controlled diabetes mellitus. |
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Detailed Description | Background: Patients with diabetes and elevated hemoglobin A1c (HbA1c) are at risk for diabetes-related complications. Care-management may be helpful in these patients, by providing direct contact between such high-risk patients and the healthcare system. Web-based systems have previously shown promise as a means of neutralizing access barriers such as scheduling and travel to appointments and may be of particular help in improving diabetes care. Objectives: We examined the efficacy of two methods of diabetes education and care management: (1) a traditional model that involved telephone contact and face-to-face encounters (2) a web-based model with access to a diabetes care management web site. We compared these interventions to a study group that received no education or care management but was provided with a computer and access to diabetes self-management websites. Methods: This study employed a randomized, parallel group design involving patients with diabetes mellitus and an elevated HbA1c ( 8.5%). Participants assigned to web-based care management received a notebook computer, Internet access and interacted with a care manager through a diabetes education and care management website. Participants receiving telephone-based care management interacted with a care manager using telephone and face-to-face contact. Both care management models employed medication algorithms to improve glucose and BP control. These care management groups were compared to a study group that had no care management but received a notebook computer and Internet access with their "home page" containing links to a series of diabetes self-management websites (i.e. computer only group). The primary outcome measures were HbA1c, blood pressure, and scores on the Problem Areas in Diabetes (PAID) questionnaire, each measured over 12-months. Status: Complete |
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Study Type ICMJE | Interventional | ||||
Study Phase | |||||
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 |
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Intervention ICMJE |
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Publications * |
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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 | 152 | ||||
Completion Date | June 2010 | ||||
Primary Completion Date | April 2007 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||
Ages | 25 Years to 79 Years | ||||
Accepts Healthy Volunteers | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Location Countries ICMJE | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT00105898 | ||||
Other Study ID Numbers ICMJE | TEL 02-100 | ||||
Has Data Monitoring Committee | No | ||||
Responsible Party | Department of Veterans Affairs | ||||
Study Sponsor ICMJE | Department of Veterans Affairs | ||||
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Investigators ICMJE |
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Information Provided By | Department of Veterans Affairs | ||||
Verification Date | August 2010 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |