Impact of a Diabetes Transitions Tool Kit on Post-Hospitalization Glycemic Control (DTTK)
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| First Received Date ICMJE | December 14, 2011 | ||||||||
| Last Updated Date | April 18, 2012 | ||||||||
| Start Date ICMJE | December 2011 | ||||||||
| Estimated Primary Completion Date | June 2013 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Glycemic Control [ Time Frame: 1 month from discharge ] [ Designated as safety issue: No ] Mean glucose (from glucometer downloads) over the 30 days after discharge, and change in glycated albumin from hospitalization to 30 days after discharge. |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT01495975 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
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| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Impact of a Diabetes Transitions Tool Kit on Post-Hospitalization Glycemic Control | ||||||||
| Official Title ICMJE | Impact of a Web-based Diabetes Transitions Tool Kit on Post-Hospitalization Glycemic Control | ||||||||
| Brief Summary | The goal of this research is to evaluate the impact and feasibility of using web-based patient-provider communication and a remote glucose monitoring tool to improve post-hospitalization glycemic control and patient self-care. The investigators hypothesize that providing patients this web-based tool over a 4-week period after discharge to home will result in more effective glycemic control compared to usual care, and that patients with access to the "tool kit" will have a trend towards improved diabetes self-management and less diabetes-related distress. |
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| Detailed Description | Diabetes affects 12-25% of all hospitalized adult patients, and 30% of hospitalized diabetes patients have one or more readmissions within one year. While glycemic control is rarely the primary reason for admission, poor glycemic control has been associated with increased rates of hospitalization and worse clinical outcomes, including infections, poor wound healing, and death. Hospitalization has been proposed as a "teachable moment" for patients with diabetes, as they have intensive contact with a full range of expert clinicians, but the effects of changes implemented during hospitalization after discharge are poorly studied. The objective of this study is to conduct a randomized controlled trial to test a novel approach to diabetes management in the transition from inpatient to outpatient care. We will assign 40 hospitalized adult patients with type 2 diabetes to usual care or access to a web-based patient-provider communication and remote glucose monitoring tool ("Diabetes Transitions Tool Kit"). Our aims are to evaluate feasibility of implementation of the tool as well as impact on post-discharge glycemic control, diabetes-related self-care and distress. We hypothesize that providing patients this web-based tool over a 4-week period after discharge to home will result in more effective glycemic control compared to usual care, and that patients with access to the "tool kit" will have a trend towards improved diabetes self-management and less diabetes-related distress. Feasibility and preliminary data from this pilot study will be the foundation for larger-scale interventions that may ultimately improve the delivery of diabetes care in the transition from hospital to home. |
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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 | Other: Diabetes Transitions Tool Kit
Access to a remote glucose monitoring and a web-based patient-provider communication portal, the Diabetes Transitions Toolkit (DTTK), for the month after discharge. |
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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 | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 40 | ||||||||
| Estimated Completion Date | July 2013 | ||||||||
| Estimated Primary Completion Date | June 2013 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01495975 | ||||||||
| Other Study ID Numbers ICMJE | 2011p-001573, 5K23DK080228-05 | ||||||||
| Has Data Monitoring Committee | Yes | ||||||||
| Responsible Party | Deborah Wexler, MD, Massachusetts General Hospital | ||||||||
| Study Sponsor ICMJE | Deborah Wexler, MD | ||||||||
| Collaborators ICMJE | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | ||||||||
| Investigators ICMJE |
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| Information Provided By | Massachusetts General Hospital | ||||||||
| Verification Date | January 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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