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The Effect of Patients' Participation in Improving Diabetes Care

This study has been completed.
Sponsor:
Information provided by:
Soroka University Medical Center
ClinicalTrials.gov Identifier:
NCT00533494
First received: September 20, 2007
Last updated: November 11, 2007
Last verified: April 2003
History of Changes
  Purpose

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 Intervention Phase
Type 2 Diabetes Mellitus
 Behavioral: physician feedback (A)
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Supportive Care

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Soroka University Medical Center:

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

Study Start Date: January 2000
Study Completion Date: September 2003
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   30 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00533494

Locations
Israel
Clalit Health Services
Beersheva, Afula, Migdal Haemek, Israel
Sponsors and Collaborators
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
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00533494     History of Changes
Other Study ID Numbers: sor166899ctil
Study First Received: September 20, 2007
Last Updated: November 11, 2007
Health Authority: Israel: Ministry of Health

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

ClinicalTrials.gov processed this record on May 21, 2013