- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00533494
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
-
-
-
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
|
Feedback information to physicians
|
Active Comparator: A
Feedback information to physicians
|
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
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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