Hypertension and Diabetes Initiative - Improving Hypertension Control in Individuals With Diabetes
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ClinicalTrials.gov Identifier: NCT00743808 |
Recruitment Status
:
Completed
First Posted
: August 29, 2008
Last Update Posted
: December 2, 2015
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Tracking Information | |||||||
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First Submitted Date | June 9, 2008 | ||||||
First Posted Date | August 29, 2008 | ||||||
Last Update Posted Date | December 2, 2015 | ||||||
Study Start Date | December 2006 | ||||||
Actual Primary Completion Date | May 2008 (Final data collection date for primary outcome measure) | ||||||
Current Primary Outcome Measures |
Systolic blood pressure [ Time Frame: 1 year ] | ||||||
Original Primary Outcome Measures | Same as current | ||||||
Change History | Complete list of historical versions of study NCT00743808 on ClinicalTrials.gov Archive Site | ||||||
Current Secondary Outcome Measures |
Measure changes in action taken related to improving blood pressure management as percent of providers reporting changing (initiating or adjusting) blood pressure medication [ Time Frame: 1 year ] | ||||||
Original Secondary Outcome Measures | Same as current | ||||||
Current Other Outcome Measures | Not Provided | ||||||
Original Other Outcome Measures | Not Provided | ||||||
Descriptive Information | |||||||
Brief Title | Hypertension and Diabetes Initiative - Improving Hypertension Control in Individuals With Diabetes | ||||||
Official Title | Improving Hypertension Control in Individuals With Diabetes | ||||||
Brief Summary | Twelve health organizations from around the US were selected to participate in a chart review Hypertension and Diabetes Initiative with the goal of improving blood pressure control in persons with diabetes. Hypothesis: A three-phase quality improvement initiative facilitated and monitored through the International Diabetes Center (IDC) will result in improved population-mean systolic blood pressure in the aggregate data pool of patients from all 12 participating sites at geographically distinct health systems. |
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Detailed Description | Phase 1 - Preparation: Each participating site begins to organize itself for the project. Baseline data will be collected and will be used to benchmark where each site is relative to blood pressure control/management of persons with diabetes prior to the implementation of the training programs. Phase 2 - Implementation: Sites begin to address the gaps they have identified that affect blood pressure outcomes of patients with diabetes. IDC provides two on-site training programs for providers and support staff. Phase 3 - Follow-up: IDC provides on-going support to each site via individual and collaborative conference calls and resources on the project Web site. Patient and visit data (audit form) will be collected six and 12 months after training. This data will be compared to the site's pre-training data. |
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Study Type | Observational | ||||||
Study Design | Observational Model: Cohort Time Perspective: Prospective |
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Target Follow-Up Duration | Not Provided | ||||||
Biospecimen | Not Provided | ||||||
Sampling Method | Probability Sample | ||||||
Study Population | Primary care clinic | ||||||
Condition | Hypertension | ||||||
Intervention | Other: quality improvement
3-phase quality improvement intervention |
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Study Groups/Cohorts | 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 | Completed | ||||||
Actual Enrollment |
11510 | ||||||
Original Actual Enrollment |
1 | ||||||
Actual Study Completion Date | September 2010 | ||||||
Actual Primary Completion Date | May 2008 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years to 75 Years (Adult, Senior) | ||||||
Accepts Healthy Volunteers | No | ||||||
Contacts | Contact information is only displayed when the study is recruiting subjects | ||||||
Listed Location Countries | Not Provided | ||||||
Removed Location Countries | |||||||
Administrative Information | |||||||
NCT Number | NCT00743808 | ||||||
Other Study ID Numbers | 03527-06-C | ||||||
Has Data Monitoring Committee | No | ||||||
U.S. FDA-regulated Product | Not Provided | ||||||
IPD Sharing Statement | Not Provided | ||||||
Responsible Party | HealthPartners Institute | ||||||
Study Sponsor | HealthPartners Institute | ||||||
Collaborators |
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Investigators |
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PRS Account | HealthPartners Institute | ||||||
Verification Date | August 2013 |