The Effect of Patients' Participation in Improving Diabetes 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. Identifier: NCT00533494
Recruitment Status : Completed
First Posted : September 21, 2007
Last Update Posted : November 14, 2007
Information provided by:
Soroka University Medical Center

Brief Summary:
Despite the advent of efficacious medicines, there is a gap between ideal and actual care in the achievement of recommended outcomes among diabetic patients. The study enrolled 429 diabetic patients attending four HMO clinics in Israel, two in the northern region and two in the southern region. All clinics were randomly selected from all clinics affiliated with the Faculty of Health Sciences of the Ben Gurion University. The objective of the study was to compare the effects of a multi-component physician-patient intervention to physician feedback alone on a combined outcome of diabetes, blood pressure and serum lipids control. We hypothesized that in medical practices where physicians have received feedback on quality of care indicators, patients who received a letter encouraging them to discuss a list of important diabetes-related issues with their doctors, would experience better outcomes compared to patients who did no received such a letter.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Behavioral: physician feedback (A) Phase 3

Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Study Start Date : January 2000
Actual Study Completion Date : September 2003

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: B
Feedback to physicians + reminder letters to patients
Behavioral: physician feedback (A)
Feedback information to physicians
Active Comparator: A
Feedback information to physicians
Behavioral: physician feedback (A)
Feedback information to physicians

Primary Outcome Measures :
  1. HbA1c, LDL, systolic blood pressure [ Time Frame: Baseline and 1 year after 1-year intervention ]

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Ages Eligible for Study:   30 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Known diabetic patients enrolled in the four primary care clinics
  • Age 30 years and older.

Exclusion Criteria:

  • Below age 30 years
  • Type 1 diabetes
  • Spoke neither Hebrew nor Russian
  • Bedridden or confined to home.

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 identifier (NCT number): NCT00533494

Clalit Health Services
Beersheva, Afula, Migdal Haemek, Israel
Sponsors and Collaborators
Soroka University Medical Center
Study Chair: Shimon Weitzman, MD, MPH Department of Epidemiology- Faculty of Health Sciences-Ben Gurion University
Principal Investigator: Hava Tabenkin, MD, LLB Department of Family Medicine, Afula - Clalit Health Services
Principal Investigator: Sheldon Greenfield, MD Department of Medicine, School of Medicine,UCI
Principal Investigator: Sherrie H Kaplan, PhD Department of Medicine, School of Medicine,ICI Identifier: NCT00533494     History of Changes
Other Study ID Numbers: sor166899ctil
First Posted: September 21, 2007    Key Record Dates
Last Update Posted: November 14, 2007
Last Verified: April 2003

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases