NCT03094819

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
4,500

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 17, 2016

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

April 1, 2016

Completed
12 months until next milestone

First Posted

Study publicly available on registry

March 29, 2017

Completed
6.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2023

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

April 29, 2022

Status Verified

April 1, 2022

Enrollment Period

7.3 years

First QC Date

April 1, 2016

Last Update Submit

April 28, 2022

Conditions

Diabetic RetinopathyDiabetic Macular Edema

Outcome Measures

Primary Outcomes (1)

  • Qualified eye examination rate

    Percent of participants in each study group obtaining a qualified eye examination.

    12 months

Secondary Outcomes (9)

  • PCP report rate

    12 months

  • PCP medical record rate

    12 months

  • Eye examination barriers

    12 months

  • Increased risk group eye examination rate

    12 months

  • Eye examination findings

    12 months

  • +4 more secondary outcomes

Study Arms (3)

Group 1

NO 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.

Financial Incentive

EXPERIMENTAL

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.

Behavioral: Financial Incentive

Retinal Care DR

EXPERIMENTAL

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.

Behavioral: Retinal Care DR

Interventions

Financial IncentiveBEHAVIORAL

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

Financial Incentive
Retinal Care DRBEHAVIORAL

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.

Retinal Care DR

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosed diabetes using the criteria documented in the 2016 Physician Quality Reporting System (PQRS) Measure Specifications Manual for Claims and Registry Reporting of Individual Measures.
  • through 75 years of age
  • Have a PCP appointment scheduled within 90 days of the date of medical record review.

You may not qualify if:

  • Patients not diagnosed with diabetes
  • History of photosensitive epilepsy
  • Inability or unwillingness of the participant to give verbal or written informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dean McGee Eye Institute

Oklahoma City, Oklahoma, 73104-5065, United States

Location

MeSH Terms

Conditions

Diabetic Retinopathy

Condition Hierarchy (Ancestors)

Retinal DiseasesEye DiseasesDiabetic AngiopathiesVascular DiseasesCardiovascular DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System Diseases

Study Officials

  • Ronald M Kingsley, MD

    Dean McGee Eye Institute / University of Oklahoma Health Sciences Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 1, 2016

First Posted

March 29, 2017

Study Start

March 17, 2016

Primary Completion

June 30, 2023

Study Completion

December 31, 2023

Last Updated

April 29, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)