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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00223340
Recruitment Status : Completed
First Posted : September 22, 2005
Last Update Posted : July 2, 2012
Sponsor:
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

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.

Condition or disease Intervention/treatment Phase
Diabetes Behavioral: Patient Activation and Diabetes Registry Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single
Official Title: Diabetes and Cardiovascular Risks in Primary Care
Study Start Date : March 2005
Actual Primary Completion Date : June 2007
Study Completion Date : June 2007



Primary Outcome Measures :
  1. 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 :
  1. Patient Outcome Measures: Hemoglobin A1c (HbA1c), lipids (low-density lipoprotein [LDL] non-high-density lipoprotein [HDL] triglycerides), blood pressure
  2. Patient assessed health status, diabetes self-care activities and knowledge of cardiovascular (CV) risk factors
  3. Physician Outcome Measures: Physician knowledge, attitude and readiness to change practice; Physician-level measure of patient-centeredness of encounter and interpersonal communication
  4. Assessment of Chronic Illness Care (ACIC) Surveys


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00223340


Locations
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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
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Principal Investigator: Michael L Parchman, MD, MPH Univ. of Texas Health Science Center at San Antonio
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Responsible Party: The University of Texas Health Science Center at San Antonio
ClinicalTrials.gov Identifier: NCT00223340    
Other Study ID Numbers: 1 R34 DK 067300-1A1 [NIDDK]
1 R34 DK 067300-1A1 [NIDDK]
First Posted: September 22, 2005    Key Record Dates
Last Update Posted: July 2, 2012
Last Verified: June 2012
Keywords provided by The University of Texas Health Science Center at San Antonio:
patient activation
primary care
diabetes
cardiovascular risk
Additional relevant MeSH terms:
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Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases