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The Effect of Patients' Participation in Improving Diabetes Care

NCT ID: NCT00533494

Last Updated: 2007-11-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

2000-01-31

Study Completion Date

2003-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Type 2 Diabetes Mellitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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B

Feedback to physicians + reminder letters to patients

Group Type ACTIVE_COMPARATOR

physician feedback (A)

Intervention Type BEHAVIORAL

Feedback information to physicians

A

Feedback information to physicians

Group Type ACTIVE_COMPARATOR

physician feedback (A)

Intervention Type BEHAVIORAL

Feedback information to physicians

Interventions

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physician feedback (A)

Feedback information to physicians

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Soroka University Medical Center

OTHER

Sponsor Role lead

Principal Investigators

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Shimon Weitzman, MD, MPH

Role: STUDY_CHAIR

Department of Epidemiology- Faculty of Health Sciences-Ben Gurion University

Hava Tabenkin, MD, LLB

Role: PRINCIPAL_INVESTIGATOR

Department of Family Medicine, Afula - Clalit Health Services

Sheldon Greenfield, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Medicine, School of Medicine,UCI

Sherrie H Kaplan, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Medicine, School of Medicine,ICI

Locations

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Clalit Health Services

Beersheva, Afula, Migdal Haemek, , Israel

Site Status

Countries

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Israel

Other Identifiers

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sor166899ctil

Identifier Type: -

Identifier Source: org_study_id