A Prospective Study on Diabetes Management Through an Integrated Delivery System (DMIDS)
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| First Received Date ICMJE | February 7, 2006 | ||||||||
| Last Updated Date | January 26, 2010 | ||||||||
| Start Date ICMJE | July 2003 | ||||||||
| Primary Completion Date | December 2007 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Through the health manager's coordination and consultation, diabetic patients will have better glycemic control for fasting plasma glucose, HbA1c, and blood cholesterol level. | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT00288678 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
Patients in the intervention group will have better health status such as lower hospitalization rate, shorter length of stay in hospitals, and fewer diabetic complications. | ||||||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | A Prospective Study on Diabetes Management Through an Integrated Delivery System | ||||||||
| Official Title ICMJE | A Prospective Study on Diabetes Management Through an Integrated Delivery System | ||||||||
| Brief Summary |
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| Detailed Description | Five general hospitals, including both public and private, are chosen as regional coordinating centers in this project. Collaborating with community physicians, project coordinating-centers randomize diabetic patients, who have signed informed consent, into either intervention or control group. While two annual comprehensive lab tests are offered to the control group, an additional package of consultations and coordinating services provided by health managers is appended to the intervention group. Qualified health managers are cultivated in five selected medical institutes to support primary care physicians in managing diabetic patients. Responsibilities of health managers include tracking and updating enrolled patients' information, providing adequate and scheduled consultations, arranging specialty referrals for patients in needs, and transferring stable patients back to their original physicians. The feasibility phase of the project implementation will last for three years and it will be followed by a phase of full-scale implementation for another two years. Glycemic control as well as health status of participants will be the indicators to evaluate outcome of the project. At the same time, the periodic measurements on glucose, blood pressures, lipids and the incidence of complications will also be analyzed to set up an optimal target for diabetic control in Taiwan. |
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| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Phase 3 | ||||||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) |
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| Condition ICMJE | Diabetes Mellitus | ||||||||
| Intervention ICMJE | Procedure: Health Education | ||||||||
| Study Arm (s) | Not Provided | ||||||||
| 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 | 1222 | ||||||||
| Completion Date | December 2007 | ||||||||
| Primary Completion Date | December 2007 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
3.2-hour plasma glucose 200 mg/dl (11.1 mmol/l) during an oral glucose tolerance test (OGTT). The test should be performed using a glucose load containing the equivalent of 75-g anhydrous glucose dissolved in water. Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 30 Years to 70 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||
| Location Countries ICMJE | Taiwan | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT00288678 | ||||||||
| Other Study ID Numbers ICMJE | HP-PP08 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | Center for Healthy Policy Research and Development, National Health Research Institutes, Taiwan | ||||||||
| Study Sponsor ICMJE | National Health Research Institutes, Taiwan | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| Information Provided By | National Health Research Institutes, Taiwan | ||||||||
| Verification Date | February 2008 | ||||||||
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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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