Outreach for Diabetes Cure

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Colorado, Denver
ClinicalTrials.gov Identifier:
NCT01384045
First received: June 27, 2011
Last updated: December 17, 2012
Last verified: June 2011
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Randomized Trial of Health Promotion Outreach for Diabetes Cure

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Composite Measure of Guideline Concordance [ Time Frame: After 1 year ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT01384045     History of Changes
Other Study ID Numbers: 08-0005
Study First Received: June 27, 2011
Last Updated: December 17, 2012
Health Authority: Unites States: COMIRB

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

ClinicalTrials.gov processed this record on August 21, 2014