NCT00167284

Brief Summary

With the advent of managed care, increasing responsibility for the care of patients with diabetes is being placed on primary care physicians. Evidence exists that physicians are not meeting established practice guidelines, and outcomes in patients with diabetes are less than optimal. It is thus the objective of this study to institute a community-based diabetes education intervention for both physicians and patients to enhance adherence to guidelines and improve patient outcomes. We will conduct a chart review (submitted under a separate IRB: #000733) in primary care practices to determine health status and guideline adherence. Following the chart review, physician practices will be assigned to one of three groups: physician + patient education, physician education alone, and usual care. Following the intervention, a repeat chart review will be conducted. Pre and posttest comparisons will be conducted to examine changes primarily in glycemic control, quality of life, patient knowledge, and physician adherence to practice guidelines. Secondarily, we will examine changes in therapeutic intervention, body mass index, and barriers to diabetes care. We will also examine individual barriers to diabetes care and their influence on outcomes in this population. The last phase of the study will encompass a second follow-up visit in which we will examine behavioral factors related to clinical change and sustainability of the intervention.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
270

participants targeted

Target at P75+ for not_applicable diabetes

Timeline
Completed

Started Oct 2001

Typical duration for not_applicable diabetes

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2001

Completed
3.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2005

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

September 9, 2005

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 14, 2005

Completed
Last Updated

September 14, 2005

Status Verified

September 1, 2005

First QC Date

September 9, 2005

Last Update Submit

September 9, 2005

Conditions

Keywords

chronic care model, diabetes, community, diabetes education

Outcome Measures

Primary Outcomes (3)

  • A1c

  • Blood Pressure

  • Lipids

Secondary Outcomes (4)

  • Quality of Well Being

  • Empowerment

  • Physician attitudes

  • Patient and physician barriers to diabetes care

Interventions

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • over age 18, diagnosed diabetes, physician is participating in study

You may not qualify if:

  • pregnancy, imprisonment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

PhysiciansPatient Education as Topic

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Health PersonnelHealth Care Facilities Workforce and ServicesHealth EducationPreventive Health ServicesHealth Services

Study Officials

  • Janice C Zgibor, PhD

    University of Pittsburgh

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
ECT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 9, 2005

First Posted

September 14, 2005

Study Start

October 1, 2001

Study Completion

February 1, 2005

Last Updated

September 14, 2005

Record last verified: 2005-09