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Financial Incentive for Eye Exams in Diabetic Retinopathy

N/A

Waitlist Available

Led By Ronald M Kingsley, MD

Research Sponsored by Retinal Care Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

Study Summary

This trial is designed to finalize operational details and gather pilot data for the main study. The main study is a prospective randomized controlled trial with three groups. The primary endpoint is the percentage of participants in each group who get a qualified eye examination within 12 months of enrolling.

Who is the study for?

This trial is for people aged 18-75 with diagnosed diabetes who have a primary care appointment scheduled within the next 90 days. It's not suitable for individuals with photosensitive epilepsy or those unable to consent to participate.Check my eligibility

What is being tested?

PROTECT2 is testing whether financial incentives and specialized retinal care can encourage diabetic patients to get an eye exam within a year of joining the study. Participants are randomly placed into three groups in this controlled trial.See study design

What are the potential side effects?

Since this trial involves financial incentives and retinal care rather than medication, traditional side effects are not applicable. However, there may be indirect effects related to receiving or not receiving additional care.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Qualified eye examination rate

Secondary outcome measures

Eye care costs

Eye examination barriers

Eye examination components

+6 more

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Retinal Care DRExperimental Treatment1 Intervention

Participants randomized to the Retinal Care DR Service group 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.

Group II: Financial IncentiveExperimental Treatment1 Intervention

Participants randomized to the Financial Incentive group will be offered a financial incentive in conjunction with their usual eye care. They will receive usual care and a $25 payment if they obtain a confirmed eye examination.

Group III: Group 1Active Control1 Intervention

Participants randomized to Group 1 will be the control group. They will be observed while they receive usual eye care without any study intervention.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Financial Incentive

2016

N/A

~63450

Do I qualify?Apply below to find out