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PROTECT2: Diabetes Care - Eye Exam

NCT03094819 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 4500

Last updated 2022-04-29

No results posted yet for this study

Summary

The PROTECT2 pilot study is a single cohort prospective study to gather pilot data and finalize operational details of the main study.

The PROTECT2 main study is a prospective randomized controlled multi-center three group clinical trial. The primary endpoint is the percentage of participants in each study group obtaining a qualified eye examination within 12 months of their enrollment in the study.

Conditions

Interventions

BEHAVIORAL

Financial Incentive

Participants will receive usual care and a $25 payment if they obtain a confirmed eye examination.

BEHAVIORAL

Retinal Care DR

Participants will receive: (1) point of care risk assessment for vision- threatening diabetic retinopathy, (2) retinal specialist interpretation of their risk assessment data, and (3) care coordination designed to improve the eye examination rate for patients with diabetes at increased risk for vision- threatening diabetic retinopathy.

Sponsors & Collaborators

  • Dean A. McGee Eye Institute

    collaborator OTHER

  • Retinal Care Inc.

    lead INDUSTRY

Principal Investigators

  • Ronald M Kingsley, MD · Dean McGee Eye Institute / University of Oklahoma Health Sciences Center

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-03-17
Primary Completion
2023-06-30
Completion
2023-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03094819 on ClinicalTrials.gov