Trial Outcomes & Findings for Patient Navigator Intervention for Diabetic Retinopathy (NCT NCT05188703)
NCT ID: NCT05188703
Last Updated: 2026-03-11
Results Overview
The number of participants who had their baseline eye exam will be determined using the electronic health record
COMPLETED
NA
35 participants
baseline
2026-03-11
Participant Flow
35 participants signed consent, 2 lost to follow up prior to starting intervention, 33 participants started the intervention.
Participant milestones
| Measure |
Intervention Arm
Intervention consists of standard of care eye exam and enrollment in a patient navigation program.
|
|---|---|
|
Overall Study
STARTED
|
33
|
|
Overall Study
Completed Month 3 Interview
|
30
|
|
Overall Study
Completed Month 6 Interview
|
26
|
|
Overall Study
Completed Month 9 Interview
|
25
|
|
Overall Study
Completed Month 12 Interview
|
25
|
|
Overall Study
COMPLETED
|
25
|
|
Overall Study
NOT COMPLETED
|
8
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Patient Navigator Intervention for Diabetic Retinopathy
Baseline characteristics by cohort
| Measure |
Intervention Arm
n=35 Participants
Intervention consists of standard of care eye exam and enrollment in a patient navigation program.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=9 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
29 Participants
n=9 Participants
|
|
Age, Categorical
>=65 years
|
6 Participants
n=9 Participants
|
|
Age, Continuous
|
52.26 years
STANDARD_DEVIATION 13.65 • n=9 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=9 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
9 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
25 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=9 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Black or African American
|
15 Participants
n=9 Participants
|
|
Race (NIH/OMB)
White
|
13 Participants
n=9 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=9 Participants
|
|
Region of Enrollment
United States
|
35 participants
n=9 Participants
|
PRIMARY outcome
Timeframe: baselineThe number of participants who had their baseline eye exam will be determined using the electronic health record
Outcome measures
| Measure |
Intervention Arm
n=33 Participants
Intervention consists of standard of care eye exam and enrollment in a patient navigation program.
|
|---|---|
|
Number of Participant Who Had Baseline Eye Exam
|
33 Participants
|
PRIMARY outcome
Timeframe: up to 18 monthPercentage of participants who completed a follow-up eye exam 12-18 months after baseline eye exam will be determined using the electronic health record
Outcome measures
| Measure |
Intervention Arm
n=33 Participants
Intervention consists of standard of care eye exam and enrollment in a patient navigation program.
|
|---|---|
|
Percentage of Participants Who Completed a Follow-up Eye Exam 12-18 Months After Baseline Eye Exam
|
71 percentage of participants
|
Adverse Events
Intervention Arm
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place