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The Effect of Patients' Participation in Improving Diabetes Care

Primary Purpose

Type 2 Diabetes Mellitus

Status
Completed
Phase
Phase 3
Locations
Israel
Study Type
Interventional
Intervention
physician feedback (A)
Sponsored by
Soroka University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Type 2 Diabetes Mellitus

Eligibility Criteria

30 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Clalit Health Services

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

B

A

Arm Description

Feedback to physicians + reminder letters to patients

Feedback information to physicians

Outcomes

Primary Outcome Measures

HbA1c, LDL, systolic blood pressure

Secondary Outcome Measures

Full Information

First Posted
September 20, 2007
Last Updated
November 11, 2007
Sponsor
Soroka University Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT00533494
Brief Title
The Effect of Patients' Participation in Improving Diabetes Care
Study Type
Interventional

2. Study Status

Record Verification Date
April 2003
Overall Recruitment Status
Completed
Study Start Date
January 2000 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 2003 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Soroka University Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized

8. Arms, Groups, and Interventions

Arm Title
B
Arm Type
Active Comparator
Arm Description
Feedback to physicians + reminder letters to patients
Arm Title
A
Arm Type
Active Comparator
Arm Description
Feedback information to physicians
Intervention Type
Behavioral
Intervention Name(s)
physician feedback (A)
Intervention Description
Feedback information to physicians
Primary Outcome Measure Information:
Title
HbA1c, LDL, systolic blood pressure
Time Frame
Baseline and 1 year after 1-year intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shimon Weitzman, MD, MPH
Organizational Affiliation
Department of Epidemiology- Faculty of Health Sciences-Ben Gurion University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Hava Tabenkin, MD, LLB
Organizational Affiliation
Department of Family Medicine, Afula - Clalit Health Services
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sheldon Greenfield, MD
Organizational Affiliation
Department of Medicine, School of Medicine,UCI
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sherrie H Kaplan, PhD
Organizational Affiliation
Department of Medicine, School of Medicine,ICI
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clalit Health Services
City
Beersheva, Afula, Migdal Haemek
Country
Israel

12. IPD Sharing Statement

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The Effect of Patients' Participation in Improving Diabetes Care

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