TREAT (Telemedicine for Reach, Education, Access, and Tre... | NCT01339208

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

NCT01339208

Sponsor

University of Pittsburgh

Status

Completed

Last Update Posted

May 28, 2015Estimated

Enrollment

35Actual

Phase

Not Applicable

Conditions

Type 2 Diabetes

Interventions

Telemedicine diabetes intervention

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2011

Primary Completion Date

Mar 2015Actual

Completion Date

Mar 2015Actual

First Submitted Date

Apr 14, 2011

First Submission Date that Met QC Criteria

Apr 19, 2011

First Posted Date

Apr 20, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 26, 2015

Last Update Posted Date

May 28, 2015Estimated

Name	Class
United States Department of Defense	FED

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

35Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Telemedicine Diabetes Intervention	Experimental		Other: Telemedicine diabetes intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Telemedicine diabetes intervention	Other	3 month duration telemedicine consultation and diabetes education	Telemedicine Diabetes Intervention

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

Measure	Description	Time Frame
Patient satisfaction		6 month

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Frederico Toledo, MD	University of Pittsburgh	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
UPMC Northwest		Seneca	Pennsylvania	16346	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
25061149	Derived	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.

ID	Term
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases