The ABC Planning Study: Diabetes and Cardiovascular Risks in Primary Care

Not Applicable

Completed

• Conditions: Diabetes

• Registration Number: NCT00223340
• Lead Sponsor: The University of Texas Health Science Center at San Antonio

Brief Summary

The purpose of this pilot study is to collect preliminary information about the best way to implement an intervention to reduce the risks of heart disease and stroke.

Detailed Description

This study has two types of interventions. The clinics and patients are randomly assigned to either a control or intervention group. All clinics have both control and intervention patients. In the clinic intervention, we help doctors monitor patient information about the risk factors of heart disease and stroke. In the patient intervention, we contact patients by phone to discuss these risk factors before their doctor visits.

Study Timeline

• Study Start: 2005-03
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-22
• Primary Completion: 2007-06
• Study Completion: 2007-06
• Status Verified: 2012-06
• Last Update Submitted: 2012-06-28
• Last Update Posted: 2012-07-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

• Patient must be diagnosed with diabetes for at least 12 months.
• Patient must be with current physician for at least 12 months.
• Study staff must be able to reach patient by telephone.

Exclusion Criteria

• Pregnant women are excluded.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Primary Outcome Measures

Name	Time	Method
Document changes made to study procedures to better implement this study's interventions that are designed to reduce risks of heart disease and stroke

Secondary Outcome Measures

Name	Time	Method
Patient Outcome Measures: Hemoglobin A1c (HbA1c), lipids (low-density lipoprotein [LDL] non-high-density lipoprotein [HDL] triglycerides), blood pressure
Patient assessed health status, diabetes self-care activities and knowledge of cardiovascular (CV) risk factors
Physician Outcome Measures: Physician knowledge, attitude and readiness to change practice; Physician-level measure of patient-centeredness of encounter and interpersonal communication
Assessment of Chronic Illness Care (ACIC) Surveys

Trial Locations

Locations (1)

The University of Texas Health Science Center at San Antonio (Texas); 🇺🇸 San Antonio, Texas, United States