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Outreach for Diabetes Cure

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01384045
First Posted: June 28, 2011
Last Update Posted: December 18, 2012
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.
Information provided by (Responsible Party):
University of Colorado, Denver
  Purpose
Using a socioeconomic, race/ethnic, and gender-diverse sample of patients who receive diabetes care from a University of Colorado Hospital (UCH) primary care provider (PCP), carry out a randomized-controlled trial of usual care versus an outreach intervention designed to increase guideline concordance with American Diabetes Association (ADA) recommendations for blood pressure, Low-density lipoprotein (LDL), and glycosylated hemoglobin (A1c) goals, referrals for retinal exams, and aspirin therapy.Primary hypotheses: The proportion of patients meeting goal will be 10% higher in the intervention compared with control group in the following domains: 1. LDL<100 mg/dL; 2. A1c<7.0%; and 3. Systolic blood pressure<130 mm Hg or diastolic blood pressure<80 mm Hg.

Condition Intervention
Type II Diabetes Other: Health promotion outreach

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Randomized Trial of Health Promotion Outreach for Diabetes Cure

Further study details as provided by University of Colorado, Denver:

Primary Outcome Measures:
  • Composite Measure of Guideline Concordance [ Time Frame: After 1 year ]

    Composite measure of guideline concordance with 1 point for concordance with each of the following:

    1. hemoglobin a1c less than 7%
    2. ldl cholesterol less than 100 mgs per decaliter
    3. urinary micro albumin measured in preceding 12 months
    4. both systolic bp less than 130 mms mercury & diastolic bp less than 80 mms mercury


Secondary Outcome Measures:
  • Individual measures of guideline concordance [ Time Frame: After 1 year ]
    Individual measures of guideline concordance. Assessment of the outcome measures of the composite measures separately.


Enrollment: 2800
Study Start Date: February 2009
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Usual Care
Patients continue to receive usual diabetes care without outreach by health promotions staff.
Experimental: Arm 1-Health Promotoin Outreach
Active outreach by health promotion staff to send diabetes report card and schedule services including laboratory testing and visits.
Other: Health promotion outreach
Calling patients who are due for diabetes related services, sending them an interventional letter and assisting them in getting over due serves.

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • diagnosis of type II diabetes
  • visit to University of Colorado Hospital in primary care clinic in last 18 months
  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): NCT01384045


Locations
United States, Colorado
University of Colorado Hopspital
Aurora, Colorado, United States, 80045
Sponsors and Collaborators
University of Colorado, Denver
Investigators
Principal Investigator: Steven Ross, MD University of Colorado, Denver
Principal Investigator: Razzaghi Mitra, MD University of Colorado, Denver
Principal Investigator: Lobo Ingrid, MD University of Colorado, Denver
  More Information

Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT01384045     History of Changes
Other Study ID Numbers: 08-0005
First Submitted: June 27, 2011
First Posted: June 28, 2011
Last Update Posted: December 18, 2012
Last Verified: June 2011

Keywords provided by University of Colorado, Denver:
Type II Diabetes
Diabetes

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases