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Hypertension and Diabetes Initiative - Improving Hypertension Control in Individuals With Diabetes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00743808
Recruitment Status : Completed
First Posted : August 29, 2008
Last Update Posted : December 2, 2015
Information provided by (Responsible Party):

Study Description
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.


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.

Condition or disease Intervention/treatment
Hypertension Other: quality improvement

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.

Study Design

Study Type : Observational
Actual Enrollment : 11510 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Improving Hypertension Control in Individuals With Diabetes
Study Start Date : December 2006
Primary Completion Date : May 2008
Study Completion Date : September 2010
Groups and Cohorts

Intervention Details:
    Other: quality improvement
    3-phase quality improvement intervention

Outcome Measures

Primary Outcome Measures :
  1. Systolic blood pressure [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. 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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Primary care clinic

Inclusion Criteria:

  • ICD-9 Code 250 (indicates type 1 or type 2 diabetes)
  • ICD- Code 648.0 (indicates pregnancy with type 1 or type 2 diabetes)
  • ICD-9 Code 357.2 or 362.0, indicating complications of diabetes.
  • A prescription for insulin or oral hypoglycemic agents
  • Include those 18-75 years

Exclusion Criteria:

  • Attend a dialysis unit (if the nephrologist is primary care manager)
  • Have gestational diabetes (ICD-9 Code 648.8)
  • Have a terminal illness (e.g., hospice patient)
  • Do not have a documented blood pressure within the past year (this is asked on the audit form)
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00743808

Sponsors and Collaborators
HealthPartners Institute
Advocate Medical Group
Baystate Health
William Beaumont Hospitals
Columbia Park Medical Group
Humboldt Del Norte Independent Practice Association
Metropolitan Health
Park Nicollet Clinic
PeaceHealth Medical Group
Sanford Clinic
TriHealth Inc.
University Hospitals Medical Practices
Warren Clinic
Principal Investigator: Margaret A Powers, PhD International Diabetes Center - Park Nicollet Institute
Principal Investigator: Robert M Cuddihy, MD International Diabetes Center - Park Nicollet Institute
More Information


Responsible Party: HealthPartners Institute
ClinicalTrials.gov Identifier: NCT00743808     History of Changes
Other Study ID Numbers: 03527-06-C
First Posted: August 29, 2008    Key Record Dates
Last Update Posted: December 2, 2015
Last Verified: August 2013

Keywords provided by HealthPartners Institute:
quality improvement
blood pressure

Additional relevant MeSH terms:
Vascular Diseases
Cardiovascular Diseases