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

• ClinicalTrials.gov Identifier: NCT00223340
• Recruitment Status: Completed
• First Posted: September 22, 2005
• Last Update Posted: July 2, 2012
• Sponsor: The University of Texas Health Science Center at San Antonio
• Collaborator: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Information provided by (Responsible Party): The University of Texas Health Science Center at San Antonio

Tracking Information

• First Submitted Date: September 13, 2005
• First Posted Date: September 22, 2005
• Last Update Posted Date: July 2, 2012
• Study Start Date: March 2005
• Actual Primary Completion Date: June 2007 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: January 24, 2006): Document changes made to study procedures to better implement this study's interventions that are designed to reduce risks of heart disease and stroke
• Original Primary Outcome Measures (submitted: September 13, 2005): Document changes made to study procedures to better implement this study's interventions that are designed to reduce risks of heart disease and stroke.

Current Secondary Outcome Measures (submitted: January 24, 2006)

• 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

Original Secondary Outcome Measures (submitted: September 13, 2005)

• PATIENT Outcome Measures: HbA1c, Lipids (LDL, non-HDL, Triglycerides), Blood Pressure; Patient assessed health status, diabetes self-care activities and knowledge of 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.

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: The ABC Planning Study: Diabetes and Cardiovascular Risks in Primary Care
• Official Title: Diabetes and Cardiovascular Risks in Primary Care
• 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 Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Factorial Assignment; Masking: Single
• Condition: Diabetes
• Intervention: Behavioral: Patient Activation and Diabetes Registry
• Study Arms: Not Provided
• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Enrollment (submitted: September 13, 2005): 400
• Original Enrollment: Same as current
• Study Completion Date: June 2007
• Actual Primary Completion Date: June 2007 (Final data collection date for primary outcome measure)

Eligibility Criteria

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00223340
• Other Study ID Numbers: 1 R34 DK 067300-1A1 [NIDDK]; 1 R34 DK 067300-1A1 [NIDDK]
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: The University of Texas Health Science Center at San Antonio
• Study Sponsor: The University of Texas Health Science Center at San Antonio
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Investigators

• Principal Investigator: Michael L Parchman, MD, MPH; Univ. of Texas Health Science Center at San Antonio

• PRS Account: The University of Texas Health Science Center at San Antonio
• Verification Date: June 2012