The Effect of Patients' Participation in Improving Diabetes Care

November 11, 2007 updated by: Soroka University Medical Center
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Beersheva, Afula, Migdal Haemek, Israel
        • Clalit health services

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
HbA1c, LDL, systolic blood pressure
Time Frame: Baseline and 1 year after 1-year intervention
Baseline and 1 year after 1-year intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Soroka University Medical Center

Investigators

  • 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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2000

Study Completion (Actual)

September 1, 2003

Study Registration Dates

First Submitted

September 20, 2007

First Submitted That Met QC Criteria

September 20, 2007

First Posted (Estimate)

September 21, 2007

Study Record Updates

Last Update Posted (Estimate)

November 14, 2007

Last Update Submitted That Met QC Criteria

November 11, 2007

Last Verified

April 1, 2003

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • sor166899ctil

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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