The Comparative Effectiveness of Telemedicine to Detect Diabetic Retinopathy

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2011 by Legacy Health System.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
Oregon Health and Science University
Information provided by:
Legacy Health System
ClinicalTrials.gov Identifier:
NCT01364129
First received: April 27, 2011
Last updated: June 6, 2011
Last verified: April 2011
  Purpose

This project aims to: 1) evaluate the long-term effectiveness of telemedicine to detect diabetic retinopathy when compared to traditional surveillance methods, 2) identify the health belief factors related to adherence with annual diabetic eye exams, and 3) determine the cost-effectiveness of the telemedicine system from the perspective of the community clinic, the third-party payer, and the individual patient.


Condition Intervention
Diabetic Retinopathy
Procedure: Ophthalmic Telemedicine

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Screening
Official Title: The Comparative Effectiveness of Telemedicine to Detect Diabetic Retinopathy

Resource links provided by NLM:


Further study details as provided by Legacy Health System:

Primary Outcome Measures:
  • Proportion of Participants that Receive Annual Eye Exam [ Time Frame: Baseline; Change from Baseline at 1 Year, 2 Years, 3 Years, 4 Years, and 5 Years (number of follow-up exams depends on number of years enrolled in the study) ] [ Designated as safety issue: No ]
    This outcome measure will be used to determine (1) whether the telemedicine system increases the proportion of participants that receive an annual eye exam, and (2) what health belief factors are associated with adherence.


Enrollment: 567
Study Start Date: August 2006
Estimated Study Completion Date: June 2012
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Telemedicine
Participants in this group have digital images of their retina captured with a non-mydriatic camera and are encouraged to see an eye care provider yearly.
Procedure: Ophthalmic Telemedicine
Participants receiving the intervention have digital images of their retina captured with a non-mydriatic camera. The images are then sent to Devers Eye Institute for review and report generation.
No Intervention: Traditional Surveillance
Participants in this group are encouraged to see an eye care provider each year for a diabetic eye exam.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • diabetic, at least 18 years old, patient at a participating health clinic
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01364129

Locations
United States, Kansas
Hunter Health Clinic
Wichita, Kansas, United States, 67214
United States, Oregon
Yellowhawk Tribal Health Center
Pendleton, Oregon, United States, 97801
Sponsors and Collaborators
Legacy Health System
Oregon Health and Science University
Investigators
Principal Investigator: Steven L Mansberger, MD, MPH Legacy Health System, Devers Eye Institute
Principal Investigator: Thomas M Becker, MD, PhD Oregon Health and Science University
  More Information

No publications provided

Responsible Party: Steven L. Mansberger, MD, MPH, Legacy Health System
ClinicalTrials.gov Identifier: NCT01364129     History of Changes
Other Study ID Numbers: NPAIHB O5-P-O5, 1-U-48-DP-002673
Study First Received: April 27, 2011
Last Updated: June 6, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Legacy Health System:
Diabetes
Diabetic Retinopathy Screening
Ophthalmic Telemedicine
Comparative Effectiveness Research

Additional relevant MeSH terms:
Diabetic Retinopathy
Retinal Diseases
Eye Diseases
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases

ClinicalTrials.gov processed this record on September 11, 2014