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

Diabetes Clinical Trial

Official title:

Diabetes and Cardiovascular Risks in Primary Care

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00223340
• Other study ID #: 1 R34 DK 067300-1A1 [NIDDK]
• Secondary ID: 1 R34 DK 067300-
• Status: Completed
• Phase: N/A
• First received: September 13, 2005
• Last updated: June 28, 2012
• Start date: March 2005
• Est. completion date: June 2007

Study information

• Verified date: June 2012
• Source: The University of Texas Health Science Center at San Antonio
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: June 2007
• Est. primary completion date: June 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Single Blind

Related Conditions & MeSH terms

• Diabetes

Intervention

Behavioral:
• Patient Activation and Diabetes Registry

Locations

Country	Name	City	State
United States	The University of Texas Health Science Center at San Antonio (Texas)	San Antonio	Texas

Sponsors (2)

Lead Sponsor	Collaborator
The University of Texas Health Science Center at San Antonio	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Document changes made to study procedures to better implement this study's interventions that are designed to reduce risks of heart disease and stroke			No
Secondary	Patient Outcome Measures: Hemoglobin A1c (HbA1c), lipids (low-density lipoprotein [LDL] non-high-density lipoprotein [HDL] triglycerides), blood pressure			No
Secondary	Patient assessed health status, diabetes self-care activities and knowledge of cardiovascular (CV) risk factors			No
Secondary	Physician Outcome Measures: Physician knowledge, attitude and readiness to change practice; Physician-level measure of patient-centeredness of encounter and interpersonal communication			No
Secondary	Assessment of Chronic Illness Care (ACIC) Surveys			No