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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

Tracking Information
First Submitted Date  ICMJE September 13, 2005
First Posted Date  ICMJE September 22, 2005
Last Update Posted Date July 2, 2012
Study Start Date  ICMJE March 2005
Actual Primary Completion Date June 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE
 (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.
Change History
Current Secondary Outcome Measures  ICMJE
 (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  ICMJE
 (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  ICMJE The ABC Planning Study: Diabetes and Cardiovascular Risks in Primary Care
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single
Condition  ICMJE Diabetes
Intervention  ICMJE Behavioral: Patient Activation and Diabetes Registry
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: September 13, 2005)
400
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE June 2007
Actual Primary Completion Date June 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00223340
Other Study ID Numbers  ICMJE 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  ICMJE Not Provided
Responsible Party The University of Texas Health Science Center at San Antonio
Study Sponsor  ICMJE The University of Texas Health Science Center at San Antonio
Collaborators  ICMJE National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators  ICMJE
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

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP