Using Conversation Maps to Reinforce Self-Care
| Tracking Information | |||||
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| First Received Date ICMJE | May 7, 2009 | ||||
| Last Updated Date | October 17, 2012 | ||||
| Start Date ICMJE | December 2008 | ||||
| Primary Completion Date | March 2012 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Improved frequency of recommended self-care behaviors (Self-Care Inventory-R) [ Time Frame: 3, 6, and 12 months post intervention ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00895986 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| 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 | Using Conversation Maps to Reinforce Self-Care | ||||
| Official Title ICMJE | Achieving and Maintaining Glycemic Control: Using Conversation Maps to Reinforce Self-Care | ||||
| Brief Summary | Many people with type 2 diabetes are not able to keep their blood glucose in good control. Improving blood glucose control and maintaining that improvement is important for diabetes patients because doing so delays the onset and progression of severe complications of diabetes. Although educational programs may be helpful, their effect is not always long-lasting. This project is studying whether the Conversation Maps program (an interactive diabetes education program) reinforces diabetes education and information and thus helps type 2 diabetes patients take better care of their diabetes and blood glucose levels. Half of the patients will attend the Conversation Maps program and half of the patients will attend an educational program about blood pressure and cholesterol. Also, all patients will come in for 4 or 5 appointments to complete surveys and other tests and have their blood drawn. The group of patients who attend the Conversation Maps program will be compared to the group of patients who attend the blood pressure and cholesterol program to see if the educational programs helped diabetes patients to improve their diabetes control and quality of life and to maintain that improvement over time. |
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| Detailed Description | Not Provided | ||||
| 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: Supportive Care |
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| Condition ICMJE | Type 2 Diabetes | ||||
| Intervention ICMJE |
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| Study Arm (s) |
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| 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 | 134 | ||||
| Completion Date | March 2012 | ||||
| Primary Completion Date | March 2012 (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 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 | NCT00895986 | ||||
| Other Study ID Numbers ICMJE | ADA 7-08-CR-62, CHS #08-07 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Joslin Diabetes Center | ||||
| Study Sponsor ICMJE | Joslin Diabetes Center | ||||
| Collaborators ICMJE | American Diabetes Association | ||||
| Investigators ICMJE |
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| Information Provided By | Joslin Diabetes Center | ||||
| Verification Date | October 2012 | ||||
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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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