Trial Outcomes & Findings for Incentives in Diabetic Eye Assessment by Screening (NCT NCT02339909)
NCT ID: NCT02339909
Last Updated: 2023-10-19
Results Overview
The participants will be invited to a specific appointment between three months and one year from their previous missed appointment. The primary outcome refers to the number of participants who did attend their appointment.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
1051 participants
Primary outcome timeframe
At designated appointment date (between three months and one year from previous missed appointment)
Results posted on
2023-10-19
Participant Flow
Due to the nature of the study, informed consent could not be collected. The number of participants Started in the Participant Flow (1274) refers to the number randomised. Following randomisation, but prior to being sent the intervention letter, 223 participants became ineligible, so 1051 participants were actually enrolled in the study.
Participant milestones
| Measure |
Control
The intervention for the "Control" group consists of the standard invitation letter from the Screening service. (The trial is testing the impact of the different invitation letters on the primary outcome of screening attendance.)
Control: Participants receiving the "active comparator", (i.e. "control") intervention, will be sent the standard diabetic retinopathy screening appointment letter.
|
Fixed Incentive
The intervention for the "fixed incentive" group consists of the standard invitation letter from the Screening service, with additional text offering a fixed financial incentive (£10) if they attend screening. (The trial is testing the impact of the different invitation letters on the primary outcome of screening attendance.)
Fixed financial incentive: Participants receiving the "fixed financial incentive" intervention will be sent a screening appointment letter offering them a fixed amount of £10 if they attend their screening appointment.
|
Probabilistic Incentive
The intervention for the "probabilistic incentive" group consists of the standard invitation letter from the Screening service, with additional text offering a probabilistic financial incentive (entry into a lottery offering at least a 1 in 100 chance to win £1000) if they attend screening. (The trial is testing the impact of the different invitation letters on the primary outcome of screening attendance.)
Probabilistic financial incentive: Participants receiving the "probabilistic financial incentive" intervention will be sent a screening appointment letter offering them an entry into a lottery with at least a 1 in 100 chance of winning £1000 if they attend their screening appointment.
|
|---|---|---|---|
|
Overall Study
STARTED
|
524
|
375
|
375
|
|
Overall Study
COMPLETED
|
435
|
312
|
304
|
|
Overall Study
NOT COMPLETED
|
89
|
63
|
71
|
Reasons for withdrawal
| Measure |
Control
The intervention for the "Control" group consists of the standard invitation letter from the Screening service. (The trial is testing the impact of the different invitation letters on the primary outcome of screening attendance.)
Control: Participants receiving the "active comparator", (i.e. "control") intervention, will be sent the standard diabetic retinopathy screening appointment letter.
|
Fixed Incentive
The intervention for the "fixed incentive" group consists of the standard invitation letter from the Screening service, with additional text offering a fixed financial incentive (£10) if they attend screening. (The trial is testing the impact of the different invitation letters on the primary outcome of screening attendance.)
Fixed financial incentive: Participants receiving the "fixed financial incentive" intervention will be sent a screening appointment letter offering them a fixed amount of £10 if they attend their screening appointment.
|
Probabilistic Incentive
The intervention for the "probabilistic incentive" group consists of the standard invitation letter from the Screening service, with additional text offering a probabilistic financial incentive (entry into a lottery offering at least a 1 in 100 chance to win £1000) if they attend screening. (The trial is testing the impact of the different invitation letters on the primary outcome of screening attendance.)
Probabilistic financial incentive: Participants receiving the "probabilistic financial incentive" intervention will be sent a screening appointment letter offering them an entry into a lottery with at least a 1 in 100 chance of winning £1000 if they attend their screening appointment.
|
|---|---|---|---|
|
Overall Study
Became ineligible after randomisation
|
89
|
63
|
71
|
Baseline Characteristics
Incentives in Diabetic Eye Assessment by Screening
Baseline characteristics by cohort
| Measure |
Control
n=435 Participants
The intervention for the "Control" group consists of the standard invitation letter from the Screening service. (The trial is testing the impact of the different invitation letters on the primary outcome of screening attendance.)
Control: Participants receiving the "active comparator", (i.e. "control") intervention, will be sent the standard diabetic retinopathy screening appointment letter.
|
Fixed Incentive
n=312 Participants
The intervention for the "fixed incentive" group consists of the standard invitation letter from the Screening service, with additional text offering a fixed financial incentive (£10) if they attend screening. (The trial is testing the impact of the different invitation letters on the primary outcome of screening attendance.)
Fixed financial incentive: Participants receiving the "fixed financial incentive" intervention will be sent a screening appointment letter offering them a fixed amount of £10 if they attend their screening appointment.
|
Probabilistic Incentive
n=304 Participants
The intervention for the "probabilistic incentive" group consists of the standard invitation letter from the Screening service, with additional text offering a probabilistic financial incentive (entry into a lottery offering at least a 1 in 100 chance to win £1000) if they attend screening. (The trial is testing the impact of the different invitation letters on the primary outcome of screening attendance.)
Probabilistic financial incentive: Participants receiving the "probabilistic financial incentive" intervention will be sent a screening appointment letter offering them an entry into a lottery with at least a 1 in 100 chance of winning £1000 if they attend their screening appointment.
|
Total
n=1051 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Customized
16-65 years
|
229 Participants
n=5 Participants
|
173 Participants
n=7 Participants
|
176 Participants
n=5 Participants
|
578 Participants
n=4 Participants
|
|
Age, Customized
Over 65 years
|
206 Participants
n=5 Participants
|
139 Participants
n=7 Participants
|
128 Participants
n=5 Participants
|
473 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
172 Participants
n=5 Participants
|
142 Participants
n=7 Participants
|
128 Participants
n=5 Participants
|
442 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
263 Participants
n=5 Participants
|
170 Participants
n=7 Participants
|
176 Participants
n=5 Participants
|
609 Participants
n=4 Participants
|
|
Region of Enrollment
United Kingdom
|
435 participants
n=5 Participants
|
312 participants
n=7 Participants
|
304 participants
n=5 Participants
|
1051 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: At designated appointment date (between three months and one year from previous missed appointment)The participants will be invited to a specific appointment between three months and one year from their previous missed appointment. The primary outcome refers to the number of participants who did attend their appointment.
Outcome measures
| Measure |
Control
n=435 Participants
The intervention for the "Control" group consists of the standard invitation letter from the Screening service. (The trial is testing the impact of the different invitation letters on the primary outcome of screening attendance.)
Control: Participants receiving the "active comparator", (i.e. "control") intervention, will be sent the standard diabetic retinopathy screening appointment letter.
|
Fixed Incentive
n=312 Participants
The intervention for the "fixed incentive" group consists of the standard invitation letter from the Screening service, with additional text offering a fixed financial incentive (£10) if they attend screening. (The trial is testing the impact of the different invitation letters on the primary outcome of screening attendance.)
Fixed financial incentive: Participants receiving the "fixed financial incentive" intervention will be sent a screening appointment letter offering them a fixed amount of £10 if they attend their screening appointment.
|
Probabilistic Incentive
n=304 Participants
The intervention for the "probabilistic incentive" group consists of the standard invitation letter from the Screening service, with additional text offering a probabilistic financial incentive (entry into a lottery offering at least a 1 in 100 chance to win £1000) if they attend screening. (The trial is testing the impact of the different invitation letters on the primary outcome of screening attendance.)
Probabilistic financial incentive: Participants receiving the "probabilistic financial incentive" intervention will be sent a screening appointment letter offering them an entry into a lottery with at least a 1 in 100 chance of winning £1000 if they attend their screening appointment.
|
|---|---|---|---|
|
Number of Patients Attending Screening Appointment
|
34 Participants
|
17 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: Number of patients with additional management triggered as a result of test at designated screening appointment (between three months and one year)Population: These are the numbers of each group that attended screening and had retinopathy screening
The outcome measure from screening is an ordinal measure indicating whether there is no retinopathy, or varying degrees of retinopathy. This will be measured at the screening appointment (for those participants who attend their appointment). We report whether there is further management required as a result of screening.
Outcome measures
| Measure |
Control
n=34 Participants
The intervention for the "Control" group consists of the standard invitation letter from the Screening service. (The trial is testing the impact of the different invitation letters on the primary outcome of screening attendance.)
Control: Participants receiving the "active comparator", (i.e. "control") intervention, will be sent the standard diabetic retinopathy screening appointment letter.
|
Fixed Incentive
n=16 Participants
The intervention for the "fixed incentive" group consists of the standard invitation letter from the Screening service, with additional text offering a fixed financial incentive (£10) if they attend screening. (The trial is testing the impact of the different invitation letters on the primary outcome of screening attendance.)
Fixed financial incentive: Participants receiving the "fixed financial incentive" intervention will be sent a screening appointment letter offering them a fixed amount of £10 if they attend their screening appointment.
|
Probabilistic Incentive
n=10 Participants
The intervention for the "probabilistic incentive" group consists of the standard invitation letter from the Screening service, with additional text offering a probabilistic financial incentive (entry into a lottery offering at least a 1 in 100 chance to win £1000) if they attend screening. (The trial is testing the impact of the different invitation letters on the primary outcome of screening attendance.)
Probabilistic financial incentive: Participants receiving the "probabilistic financial incentive" intervention will be sent a screening appointment letter offering them an entry into a lottery with at least a 1 in 100 chance of winning £1000 if they attend their screening appointment.
|
|---|---|---|---|
|
Number of Patients Requiring Intervention After Sight Outcome From Diabetic Retinopathy Screening.
|
6 Participants
|
7 Participants
|
5 Participants
|
Adverse Events
Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Fixed Incentive
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Probabilistic Incentive
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Control
n=435 participants at risk
The intervention for the "Control" group consists of the standard invitation letter from the Screening service. (The trial is testing the impact of the different invitation letters on the primary outcome of screening attendance.)
Control: Participants receiving the "active comparator", (i.e. "control") intervention, will be sent the standard diabetic retinopathy screening appointment letter.
|
Fixed Incentive
n=312 participants at risk
The intervention for the "fixed incentive" group consists of the standard invitation letter from the Screening service, with additional text offering a fixed financial incentive (£10) if they attend screening. (The trial is testing the impact of the different invitation letters on the primary outcome of screening attendance.)
Fixed financial incentive: Participants receiving the "fixed financial incentive" intervention will be sent a screening appointment letter offering them a fixed amount of £10 if they attend their screening appointment.
|
Probabilistic Incentive
n=304 participants at risk
The intervention for the "probabilistic incentive" group consists of the standard invitation letter from the Screening service, with additional text offering a probabilistic financial incentive (entry into a lottery offering at least a 1 in 100 chance to win £1000) if they attend screening. (The trial is testing the impact of the different invitation letters on the primary outcome of screening attendance.)
Probabilistic financial incentive: Participants receiving the "probabilistic financial incentive" intervention will be sent a screening appointment letter offering them an entry into a lottery with at least a 1 in 100 chance of winning £1000 if they attend their screening appointment.
|
|---|---|---|---|
|
Investigations
Patient invited and not suitable for screening
|
0.00%
0/435 • 1 year
|
0.32%
1/312 • Number of events 1 • 1 year
|
0.00%
0/304 • 1 year
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place