TREAT (Telemedicine for Reach, Education, Access, and Treatment) (TREAT)

May 26, 2015 updated by: Linda Siminerio, University of Pittsburgh
The purpose of this study is to evaluate the feasibility and clinical efficacy of an innovative care model that combines Telemedicine consultations, educator therapeutic management and diabetes education to empower patients to be in greater control of their own diabetes care for improvements in diabetes outcomes.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study will assess whether a new care delivery model combining telemedicine videoconference diabetes consultations with diabetes self-management teaching is efficacious in reducing HbA1c in patients with type 2 diabetes in rural areas. The control group will consist of patients with type 2 diabetes receiving "usual care", i.e., who have not received a referral to the endocrinologist telemedicine team. Secondary outcomes include patient satisfaction, level of understanding of self-management skills, and hypoglycemia

Study Type

Interventional

Enrollment (Actual)

35

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Seneca, Pennsylvania, United States, 16346
        • UPMC Northwest

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age 18 or older with type 2 diabetes
  • Referral by a primary care provider.
  • HbA1c equal or greater than 7.0%.

Exclusion Criteria:

  • Type 1 diabetes
  • Gestational Diabetes

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Telemedicine Diabetes Intervention
Other: Telemedicine diabetes intervention
3 month duration telemedicine consultation and diabetes education

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in HbA1c % from baseline
Time Frame: 3 and 6 month
3 and 6 month

Secondary Outcome Measures

Outcome Measure
Time Frame
Patient satisfaction
Time Frame: 6 month
6 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Pittsburgh

Collaborators

United States Department of Defense

Investigators

  • Principal Investigator: Frederico Toledo, MD, University of Pittsburgh

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2011

Primary Completion (Actual)

March 1, 2015

Study Completion (Actual)

March 1, 2015

Study Registration Dates

First Submitted

April 14, 2011

First Submitted That Met QC Criteria

April 19, 2011

First Posted (Estimate)

April 20, 2011

Study Record Updates

Last Update Posted (Estimate)

May 28, 2015

Last Update Submitted That Met QC Criteria

May 26, 2015

Last Verified

April 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PRO10100547

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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