Back to resultsTREAT (Telemedicine for Reach, Education, Access, and Treatment) (TREAT)
Primary Purpose
Type 2 Diabetes
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Telemedicine diabetes intervention
Sponsored by
About this trial
This is an interventional health services research trial for Type 2 Diabetes focused on measuring Type 2 Diabetes
Eligibility Criteria
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
Sites / Locations
- UPMC Northwest
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Telemedicine Diabetes Intervention
Arm Description
Outcomes
Primary Outcome Measures
Change in HbA1c % from baseline
Secondary Outcome Measures
Patient satisfaction
Full Information
NCT ID
NCT01339208
First Posted
April 14, 2011
Last Updated
May 26, 2015
Sponsor
University of Pittsburgh
Collaborators
United States Department of Defense
1. Study Identification
Unique Protocol Identification Number
NCT01339208
Brief Title
TREAT (Telemedicine for Reach, Education, Access, and Treatment)
Acronym
TREAT
Official Title
TREAT (Telemedicine for Reach, Education, Access, and Treatment)
Study Type
Interventional
2. Study Status
Record Verification Date
April 2011
Overall Recruitment Status
Completed
Study Start Date
June 2011 (undefined)
Primary Completion Date
March 2015 (Actual)
Study Completion Date
March 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pittsburgh
Collaborators
United States Department of Defense
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes
Keywords
Type 2 Diabetes
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
35 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Telemedicine Diabetes Intervention
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Telemedicine diabetes intervention
Intervention Description
3 month duration telemedicine consultation and diabetes education
Primary Outcome Measure Information:
Title
Change in HbA1c % from baseline
Time Frame
3 and 6 month
Secondary Outcome Measure Information:
Title
Patient satisfaction
Time Frame
6 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frederico Toledo, MD
Organizational Affiliation
University of Pittsburgh
Official's Role
Principal Investigator
Facility Information:
Facility Name
UPMC Northwest
City
Seneca
State/Province
Pennsylvania
ZIP/Postal Code
16346
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
25061149
Citation
Toledo FG, Ruppert K, Huber KA, Siminerio LM. Efficacy of the Telemedicine for Reach, Education, Access, and Treatment (TREAT) model for diabetes care. Diabetes Care. 2014 Aug;37(8):e179-80. doi: 10.2337/dc13-1909. No abstract available.
Results Reference
derived
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TREAT (Telemedicine for Reach, Education, Access, and Treatment)
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