Diabetic RetinopathyNCT03094819
PROTECT2: Diabetes Care - Eye Exam
A study testing Financial Incentive and Retinal Care DR in people with Diabetic Retinopathy and Diabetic Macular Edema, run by Retinal Care Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Diabetic Retinopathy, Diabetic Macular Edema
- What is being tested?
- Financial Incentive and Retinal Care DR
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4,500 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Mar 2016to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- 18 through 75 years of age
- Have a PCP appointment scheduled within 90 days of the date of medical record review.
Who cannot join
- Patients not diagnosed with diabetes
- History of photosensitive epilepsy
- Inability or unwillingness of the participant to give verbal or written informed consent.
Trial locations and contacts
1 site in 1 country.
United States1 site
Dean McGee Eye Institute
Oklahoma City, Oklahoma, 73104-5065
About this study
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.
Read the detailed description
The primary objective of this study is to compare the qualified eye examination rate in two groups of patients with diabetes receiving a new intervention, with the rate in a control group of patients with diabetes receiving usual care only.
Secondary objectives are to:
- Improve our understanding of the barriers to obtaining eye examinations;
- Evaluate the communication between eye care providers (ECP) and referring primary care providers (PCP), as determined by rates of follow-up reports sent and received;
- Characterize eye examinations provided to patients with diabetes;
- Explore the relationships between systemic variables known to affect the severity of diabetic retinopathy and the patient's risk of vision-threatening diabetic retinopathy.
Design and Primary Endpoint
- The pilot study is a single cohort prospective study to gather pilot data and finalize operational details of the main study.
- The 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.
Interventions and Duration
Eligible patients will be randomized to one of three groups in a 1:1:2 ratio.
- Group 1. 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. 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.
- Retinal Care DR Service. 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.
All participants, regardless of their group, will be in the study for about one year.
Sample Size and Population Patients meeting the inclusion and exclusion criteria will be recruited at up to four (4) study sites until the sample size of 4,500 participants is enrolled. This includes up to 500 patients at each site in the pilot study, and weighted randomization in the main study to ensure enrollment of approximately 500 patients in the Retinal Care DR Service group at each site to evaluate the operational characteristics of the Retinal Care DR Service in populations representative of those anticipated in commercial use.
- Conditions
- Diabetic Retinopathy, Diabetic Macular Edema
- Being tested
- Financial Incentive, Retinal Care DR
- Medical subject headings
- Diabetic Retinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Financial IncentiveBehavioural
Participants will receive usual care and a $25 payment if they obtain a confirmed eye examination.
Retinal Care DRBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Retinal Care DR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Qualified eye examination rate
Percent of participants in each study group obtaining a qualified eye examination.
Measured: 12 months
Secondary outcomes (9)
PCP report rate
Percent of eye examinations with a follow-up report sent to the PCP.
Measured: 12 months
PCP medical record rate
Percent of eye examinations with a follow-up report sent to the PCP, where the results of the follow-up report are documented in the PCP medical record.
Measured: 12 months
Eye examination barriers
Descriptive analysis of barriers to obtaining an eye examination.
Measured: 12 months
Increased risk group eye examination rate
Percent of participants at increased risk for vision-threatening diabetic retinopathy who are subsequently seen by an eye care provider.
Measured: 12 months
Eye examination findings
Descriptive analysis of eye examination findings for participants at increased risk for vision-threatening diabetic retinopathy.
Measured: 12 months
Eye examination components
Descriptive analysis of eye examination components for participants at increased risk for vision-threatening diabetic retinopathy.
Measured: 12 months
Eye care costs
Numerical analysis of eye care costs using provider reported and claims data.
Measured: 12 months
Risk correlations
Correlation analysis of systemic variables known to affect the severity of diabetic retinopathy and retinal specialist interpretation of participant's risk assessment data.
Measured: 12 months
Participant perceptions
Descriptive analysis of participant perceptions of the Retinal Care DR Service.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2017
- Study start17 Mar 2016
- Primary completion30 Jun 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic RetinopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 4,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Retinal Care Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Dean A. McGee Eye Institute
- Responsible party
- Sponsor
- Investigators
- Ronald M Kingsley, MD, Principal investigator, Dean McGee Eye Institute / University of Oklahoma Health Sciences Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03094819
- Sponsor's protocol ID
- 09-PLN-001
- Status last verified
- Apr 2022
- First submitted
- 1 Apr 2016
- Last updated
- 29 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PROTECT2: Diabetes Care - Eye Exam
- ClinicalTrials.gov ID
- NCT03094819
- Acronym / sponsor ID
- 09-PLN-001
- Conditions
- Diabetic Retinopathy, Diabetic Macular Edema
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 4,500 participants (estimated)
- Lead sponsor
- Retinal Care Inc.Industry (pharma, biotech, devices)
- Collaborators
- Dean A. McGee Eye Institute
- Study start
- 17 Mar 2016 (actual)
- Primary completion
- 30 Jun 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 29 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The primary objective of this study is to compare the qualified eye examination rate in two groups of patients with diabetes receiving a new intervention, with the rate in a control group of patients with diabetes receiving usual care only.
Secondary objectives are to:
- Improve our understanding of the barriers to obtaining eye examinations;
- Evaluate the communication between eye care providers (ECP) and referring primary care providers (PCP), as determined by rates of follow-up reports sent and received;
- Characterize eye examinations provided to patients with diabetes;
- Explore the relationships between systemic variables known to affect the severity of diabetic retinopathy and the patient's risk of vision-threatening diabetic retinopathy.
Design and Primary Endpoint
- The pilot study is a single cohort prospective study to gather pilot data and finalize operational details of the main study.
- The 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.
Interventions and Duration
Eligible patients will be randomized to one of three groups in a 1:1:2 ratio.
- Group 1. 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. 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.
- Retinal Care DR Service. 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.
All participants, regardless of their group, will be in the study for about one year.
Sample Size and Population Patients meeting the inclusion and exclusion criteria will be recruited at up to four (4) study sites until the sample size of 4,500 participants is enrolled. This includes up to 500 patients at each site in the pilot study, and weighted randomization in the main study to ensure enrollment of approximately 500 patients in the Retinal Care DR Service group at each site to evaluate the operational characteristics of the Retinal Care DR Service in populations representative of those anticipated in commercial use.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 | Behavioral: Financial IncentiveParticipants 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. |
| Retinal Care DR | Experimental | Behavioral: Retinal Care DRParticipants 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
- 18 through 75 years of age
- Have a PCP appointment scheduled within 90 days of the date of medical record review.
Key exclusion criteria (3 listed)
- Patients not diagnosed with diabetes
- History of photosensitive epilepsy
- Inability or unwillingness of the participant to give verbal or written informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Financial IncentiveParticipants will receive usual care and a $25 payment if they obtain a confirmed eye examination. | Behavioural | Financial Incentive |
| Retinal Care DRParticipants 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. | Behavioural | Retinal Care DR |
Primary outcome
Qualified eye examination rate
Time frame: 12 months
Percent of participants in each study group obtaining a qualified eye examination.
9 secondary outcomes
PCP report rate
Time frame: 12 months
PCP medical record rate
Time frame: 12 months
Eye examination barriers
Time frame: 12 months
Increased risk group eye examination rate
Time frame: 12 months
Eye examination findings
Time frame: 12 months
Eye examination components
Time frame: 12 months
Eye care costs
Time frame: 12 months
Risk correlations
Time frame: 12 months
Participant perceptions
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ronald M Kingsley, MD principal investigator
Dean McGee Eye Institute / University of Oklahoma Health Sciences Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Financial Incentive and Retinal Care DR in people with Diabetic Retinopathy and Diabetic Macular Edema, run by Retinal Care Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Qualified eye examination rate (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2022.