Outreach for Diabetes Cure

NCT01384045 | Completed

• 1 other identifier: 08-0005
• Study Type: interventional
• Target: 2,800
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Type II Diabetes

Keywords

Type II Diabetes; Diabetes

Outcome Measures

Primary Outcomes (1)

• Composite Measure of Guideline Concordance

  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

  After 1 year

Secondary Outcomes (1)

• Individual measures of guideline concordance

  After 1 year

Study Arms (2)

Usual Care

NO INTERVENTION

Patients continue to receive usual diabetes care without outreach by health promotions staff.

Arm 1-Health Promotoin Outreach

EXPERIMENTAL

Active outreach by health promotion staff to send diabetes report card and schedule services including laboratory testing and visits.

Other: Health promotion outreach

Interventions

Health promotion outreach OTHER

Calling patients who are due for diabetes related services, sending them an interventional letter and assisting them in getting over due serves.

Arm 1-Health Promotoin Outreach

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

Sponsors & Collaborators

• University of Colorado, Denver: lead

Study Sites (1)

University of Colorado Hopspital

Aurora, Colorado, 80045, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 27, 2011
• First Posted: June 28, 2011
• Study Start: February 1, 2009
• Primary Completion: June 1, 2011
• Study Completion: June 1, 2011
• Last Updated: December 18, 2012

Record last verified: 2011-06

Locations

US (1)