NCT01553266

Brief Summary

The purpose of this study is to evaluate the implementation of the Mobile Diabetes Education Team (MDET) intervention in the Greater Toronto Area, as well as the intervention's effectiveness in improving patient clinical and care process outcomes. The study's hypotheses are that the MDET intervention results in the following outcomes:

  • Improvement in patient clinical outcomes;
  • An increase in the proportion of primary care physicians (PCPs) performing patient care processes according to clinical practice guidelines;
  • An increase in the proportion of referrals to, and patients' utilization of, diabetes education programs (DEPs).

Trial Health

100
On Track

Trial Health Score

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

Enrollment
900

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2012

Longer than P75 for all trials

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

First Submitted

Initial submission to the registry

February 29, 2012

Completed
1 day until next milestone

Study Start

First participant enrolled

March 1, 2012

Completed
13 days until next milestone

First Posted

Study publicly available on registry

March 14, 2012

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 12, 2014

Completed
3.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 12, 2017

Completed
Last Updated

April 18, 2017

Status Verified

December 1, 2013

Enrollment Period

2 years

First QC Date

February 29, 2012

Last Update Submit

April 17, 2017

Conditions

Diabetes Mellitus

Keywords

Diabetes Mellitusdiabetes carediabetes self-management educationprimary care physiciansinterprofessional collaborationdiabetes education programsqualitativequantitativeimplementationevaluationhealth servicescoordinated careintegrated carepatient care processes

Outcome Measures

Primary Outcomes (1)

  • Change from 12 months prior to intervention in HbA1c up to 12 months during the intervention

    Change in patients' results for HbA1c from 12 months prior to intervention up to 12 months during the intervention.

    At 12 months prior to intervention; up to 12 months during the intervention

Secondary Outcomes (18)

  • Change from 12 months prior to intervention in low-density lipoprotein (LDL-C) up to 12 months during the intervention

    At 12 months prior to intervention; up to 12 months during the intervention

  • Change from 12 months prior to intervention in total cholesterol-high density lipoprotein ratio (TC-HDL ratio) up to 12 months during the intervention

    At 12 months prior to intervention; up to 12 months during the intervention

  • Change from 12 months prior to intervention in blood pressure up to 12 months during the intervention

    At 12 months prior to intervention; up to 12 months during the intervention

  • Change from 12 months prior to intervention in testing for HbA1c up to 12 months during the intervention

    At 12 months prior to intervention; up to 12 months during the intervention

  • Change from 12 months prior to intervention in blood pressure testing up to 12 months during the intervention

    At 12 months prior to intervention; up to 12 months during the intervention

  • +13 more secondary outcomes

Study Arms (2)

MDET intervention

Behavioral: Mobile Diabetes Education Teams intervention

Control group

Patients who have not received the MDET intervention.

Interventions

Mobile Diabetes Education Teams interventionBEHAVIORAL

A MDET (one Registered Nurse and Registered Dietician) supports primary care physicians by providing diabetes management education to the PCPs' patients onsite, one to four times a month based on patient volume.

Also known as: MDET
MDET intervention

Eligibility Criteria

Age18 Years+
Sexall(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Those living with diabetes

You may qualify if:

  • Has Diabetes Mellitus, Type 2;
  • Is 18 years of age or older;
  • Has an HbA1c of \> 8%.

You may not qualify if:

  • Has type of diabetes that requires intense and specialized treatment, such as Type 1 diabetes, gestational diabetes, or patients on a multiple, daily insulin regime.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Gucciardi E, Fortugno M, Horodezny S, Lou W, Sidani S, Espin S, Webster F, Shah BR. Will Mobile Diabetes Education Teams (MDETs) in primary care improve patient care processes and health outcomes? Study protocol for a randomized controlled trial. Trials. 2012 Sep 13;13:165. doi: 10.1186/1745-6215-13-165.

    PMID: 22974080DERIVED

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Enza Gucciardi, PhD

    Toronto Metropolitan University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

February 29, 2012

First Posted

March 14, 2012

Study Start

March 1, 2012

Primary Completion

March 12, 2014

Study Completion

April 12, 2017

Last Updated

April 18, 2017

Record last verified: 2013-12