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

The recruitment status of this study is unknown because the information has not been verified recently.

Verified April 2006 by The University of Texas Health Science Center at San Antonio. Recruitment status was Active, not recruiting

First Received on September 13, 2005. Last Updated on April 21, 2006 History of Changes

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:	The University of Texas Health Science Center at San Antonio
ClinicalTrials.gov Identifier:	NCT00223340

Purpose

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.

Condition	Intervention
Diabetes	Behavioral: Patient Activation and Diabetes Registry

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Factorial Assignment Masking: Single Blind Primary Purpose: Educational/Counseling/Training
Official Title:	Diabetes and Cardiovascular Risks in Primary Care

Resource links provided by NLM:

Genetics Home Reference related topics: 6q24-related transient neonatal diabetes mellitus

MedlinePlus related topics: Heart Diseases

U.S. FDA Resources

Further study details as provided by The University of Texas Health Science Center at San Antonio:

Primary Outcome Measures:

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:

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

Estimated Enrollment:	400
Study Start Date:	March 2005
Estimated Study Completion Date:	October 2006

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00223340

Locations

United States, Texas
The University of Texas Health Science Center at San Antonio (Texas)
San Antonio, Texas, United States, 78229

Sponsors and Collaborators

The University of Texas Health Science Center at San Antonio

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

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00223340 History of Changes
Other Study ID Numbers:	1 R34 DK 067300-1A1 [NIDDK], 1 R34 DK 067300-1A1 [NIDDK]
Study First Received:	September 13, 2005
Last Updated:	April 21, 2006
Health Authority:	United States: Food and Drug Administration

Keywords provided by The University of Texas Health Science Center at San Antonio:

patient activation
primary care
diabetes
cardiovascular risk

Additional relevant MeSH terms:

Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on February 09, 2012