Trial Outcomes & Findings for The Support, Educate, Empower (SEE) Program (NCT NCT04735653)
NCT ID: NCT04735653
Last Updated: 2025-11-03
Results Overview
Medication adherence will be measured objectively using electronic monitors with a bottle-in-bottle technique where all glaucoma medications are placed inside electronic pill bottles. An adherent event is defined as using an eye drop medication within a specified time window of a dose on the previous day. Adherence will be calculated as the percentage of doses taken on time divided by total doses prescribed over the six-month study period. The calculation censored participants at the time of withdrawal, loss to follow-up, or disengagement (attended the exit visit but may have gone some time before this visit without adherence monitor activity) and their adherence was calculated only during the reduced time on study. Additionally, times noted where monitors malfunctioned or went unused due to vacation or hospitalization were excluded.
COMPLETED
NA
236 participants
Up to 6 months
2025-11-03
Participant Flow
236 participants were consented. 235 were randomized. The unrandomized individual was determined to be ineligible post-consenting.
Participant milestones
| Measure |
SEE Intervention - Personalized Glaucoma Coaching
SEE Intervention - Personalized Glaucoma Coaching: This is a six-month personalized glaucoma coaching program where a coach trained in motivational interviewing (MI)-based counseling uses a web based tool that generates tailored education to help glaucoma patients identify their barriers to optimal medication adherence and explore potential solutions during three in-person coaching sessions. The coach provides between-session support through four phone calls, with two phone calls between the first and second session and one phone call after each subsequent session. Participants can elect to receive any of the following type of alarm when a dose of medication is due: visual or audible alert or automated text or phone call reminder.
|
Enhanced Care Control
Enhanced Care Control: Participants will receive non-tailored educational materials about glaucoma from leading sources by mail every 2 months for a total of 3 mailings during the 6-month study period.
|
|---|---|---|
|
Overall Study
STARTED
|
117
|
118
|
|
Overall Study
COMPLETED
|
90
|
107
|
|
Overall Study
NOT COMPLETED
|
27
|
11
|
Reasons for withdrawal
| Measure |
SEE Intervention - Personalized Glaucoma Coaching
SEE Intervention - Personalized Glaucoma Coaching: This is a six-month personalized glaucoma coaching program where a coach trained in motivational interviewing (MI)-based counseling uses a web based tool that generates tailored education to help glaucoma patients identify their barriers to optimal medication adherence and explore potential solutions during three in-person coaching sessions. The coach provides between-session support through four phone calls, with two phone calls between the first and second session and one phone call after each subsequent session. Participants can elect to receive any of the following type of alarm when a dose of medication is due: visual or audible alert or automated text or phone call reminder.
|
Enhanced Care Control
Enhanced Care Control: Participants will receive non-tailored educational materials about glaucoma from leading sources by mail every 2 months for a total of 3 mailings during the 6-month study period.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
17
|
7
|
|
Overall Study
Withdrawal by Subject
|
8
|
2
|
|
Overall Study
Death
|
0
|
2
|
|
Overall Study
Removed due to determination of participant noncompliance
|
2
|
0
|
Baseline Characteristics
The Support, Educate, Empower (SEE) Program
Baseline characteristics by cohort
| Measure |
Total
n=235 Participants
Total of all reporting groups
|
SEE Intervention - Personalized Glaucoma Coaching
n=117 Participants
SEE Intervention - Personalized Glaucoma Coaching: This is a six-month personalized glaucoma coaching program where a coach trained in motivational interviewing (MI)-based counseling uses a web based tool that generates tailored education to help glaucoma patients identify their barriers to optimal medication adherence and explore potential solutions during three in-person coaching sessions. The coach provides between-session support through four phone calls, with two phone calls between the first and second session and one phone call after each subsequent session. Participants can elect to receive any of the following type of alarm when a dose of medication is due: visual or audible alert or automated text or phone call reminder.
|
Enhanced Care Control
n=118 Participants
Enhanced Care Control: Participants will receive non-tailored educational materials about glaucoma from leading sources by mail every 2 months for a total of 3 mailings during the 6-month study period.
|
|---|---|---|---|
|
Age, Continuous
|
67.3 years
STANDARD_DEVIATION 10.9 • n=18 Participants
|
66.4 years
STANDARD_DEVIATION 11.5 • n=3 Participants
|
68.2 years
STANDARD_DEVIATION 10.4 • n=15 Participants
|
|
Sex/Gender, Customized
Female
|
124 Participants
n=18 Participants
|
64 Participants
n=3 Participants
|
60 Participants
n=15 Participants
|
|
Sex/Gender, Customized
Male
|
110 Participants
n=18 Participants
|
53 Participants
n=3 Participants
|
57 Participants
n=15 Participants
|
|
Sex/Gender, Customized
Not Reported
|
1 Participants
n=18 Participants
|
0 Participants
n=3 Participants
|
1 Participants
n=15 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
6 Participants
n=18 Participants
|
2 Participants
n=3 Participants
|
4 Participants
n=15 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
202 Participants
n=18 Participants
|
101 Participants
n=3 Participants
|
101 Participants
n=15 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
27 Participants
n=18 Participants
|
14 Participants
n=3 Participants
|
13 Participants
n=15 Participants
|
|
Race/Ethnicity, Customized
Black
|
139 Participants
n=18 Participants
|
68 Participants
n=3 Participants
|
71 Participants
n=15 Participants
|
|
Race/Ethnicity, Customized
White
|
68 Participants
n=18 Participants
|
32 Participants
n=3 Participants
|
36 Participants
n=15 Participants
|
|
Race/Ethnicity, Customized
Asian
|
10 Participants
n=18 Participants
|
6 Participants
n=3 Participants
|
4 Participants
n=15 Participants
|
|
Race/Ethnicity, Customized
Other
|
10 Participants
n=18 Participants
|
5 Participants
n=3 Participants
|
5 Participants
n=15 Participants
|
|
Race/Ethnicity, Customized
Not Reported
|
8 Participants
n=18 Participants
|
6 Participants
n=3 Participants
|
2 Participants
n=15 Participants
|
|
Region of Enrollment
United States
|
235 Participants
n=18 Participants
|
117 Participants
n=3 Participants
|
118 Participants
n=15 Participants
|
PRIMARY outcome
Timeframe: Up to 6 monthsPopulation: Data is shown for participants who provided data for this outcome.
Medication adherence will be measured objectively using electronic monitors with a bottle-in-bottle technique where all glaucoma medications are placed inside electronic pill bottles. An adherent event is defined as using an eye drop medication within a specified time window of a dose on the previous day. Adherence will be calculated as the percentage of doses taken on time divided by total doses prescribed over the six-month study period. The calculation censored participants at the time of withdrawal, loss to follow-up, or disengagement (attended the exit visit but may have gone some time before this visit without adherence monitor activity) and their adherence was calculated only during the reduced time on study. Additionally, times noted where monitors malfunctioned or went unused due to vacation or hospitalization were excluded.
Outcome measures
| Measure |
SEE Intervention - Personalized Glaucoma Coaching
n=113 Participants
SEE Intervention - Personalized Glaucoma Coaching: This is a six-month personalized glaucoma coaching program where a coach trained in motivational interviewing (MI)-based counseling uses a web based tool that generates tailored education to help glaucoma patients identify their barriers to optimal medication adherence and explore potential solutions during three in-person coaching sessions. The coach provides between-session support through four phone calls, with two phone calls between the first and second session and one phone call after each subsequent session. Participants can elect to receive any of the following type of alarm when a dose of medication is due: visual or audible alert or automated text or phone call reminder.
|
Enhanced Care Control
n=114 Participants
Enhanced Care Control: Participants will receive non-tailored educational materials about glaucoma from leading sources by mail every 2 months for a total of 3 mailings during the 6-month study period.
|
|---|---|---|
|
Mean Percent Electronically Monitored Medication Adherence Over Six Months
|
77.6 percent adherence
Standard Deviation 19.7
|
58.0 percent adherence
Standard Deviation 25.2
|
PRIMARY outcome
Timeframe: Up to 6 monthsPopulation: Data is shown for participants who provided data for this outcome.
Medication adherence will be measured objectively using electronic monitors with a bottle-in-bottle technique where all glaucoma medications are placed inside electronic pill bottles. An adherent event is defined as using an eye drop medication within a specified time window of a dose on the previous day. Adherence will be calculated as the percentage of doses taken on time divided by total doses prescribed over the six-month study period. The calculation censored participants at the time of withdrawal, loss to follow-up, or disengagement (attended the exit visit but may have gone some time before this visit without adherence monitor activity) and their adherence was calculated only during the reduced time on study. Additionally, times noted where monitors malfunctioned or went unused due to vacation or hospitalization were excluded. Continuous percentage adherence was dichotomized to a binary outcome as \>= 80% vs \< 80% medication adherence.
Outcome measures
| Measure |
SEE Intervention - Personalized Glaucoma Coaching
n=113 Participants
SEE Intervention - Personalized Glaucoma Coaching: This is a six-month personalized glaucoma coaching program where a coach trained in motivational interviewing (MI)-based counseling uses a web based tool that generates tailored education to help glaucoma patients identify their barriers to optimal medication adherence and explore potential solutions during three in-person coaching sessions. The coach provides between-session support through four phone calls, with two phone calls between the first and second session and one phone call after each subsequent session. Participants can elect to receive any of the following type of alarm when a dose of medication is due: visual or audible alert or automated text or phone call reminder.
|
Enhanced Care Control
n=114 Participants
Enhanced Care Control: Participants will receive non-tailored educational materials about glaucoma from leading sources by mail every 2 months for a total of 3 mailings during the 6-month study period.
|
|---|---|---|
|
Percentage of Participants Who Achieved >= 80% Medication Adherence Over the 6 Month Study Period
Adherence >= 80%
|
62 Participants
|
27 Participants
|
|
Percentage of Participants Who Achieved >= 80% Medication Adherence Over the 6 Month Study Period
Adherence < 80%
|
51 Participants
|
87 Participants
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Data is reported for people who came to the exit visit and provided both baseline and 6-month data
Glaucoma-related Distress will be measured by the Diabetes Distress Scale adapted for glaucoma, a 17-item scale where each item is assessed on a 6-point Likert scale. A composite score is calculated as a mean of the 17 items, ranging from 1 to 6, where a higher score indicates a higher distress level. Mean change in Glaucoma-related Distress will be compared between the intervention and control groups. Six-month change from baseline is calculated by subtracting the baseline value from the six-month score. Negative number for change indicates that participant distress decreased over time and a positive number for change would indicate that distress increased.
Outcome measures
| Measure |
SEE Intervention - Personalized Glaucoma Coaching
n=90 Participants
SEE Intervention - Personalized Glaucoma Coaching: This is a six-month personalized glaucoma coaching program where a coach trained in motivational interviewing (MI)-based counseling uses a web based tool that generates tailored education to help glaucoma patients identify their barriers to optimal medication adherence and explore potential solutions during three in-person coaching sessions. The coach provides between-session support through four phone calls, with two phone calls between the first and second session and one phone call after each subsequent session. Participants can elect to receive any of the following type of alarm when a dose of medication is due: visual or audible alert or automated text or phone call reminder.
|
Enhanced Care Control
n=107 Participants
Enhanced Care Control: Participants will receive non-tailored educational materials about glaucoma from leading sources by mail every 2 months for a total of 3 mailings during the 6-month study period.
|
|---|---|---|
|
Change in Glaucoma-related Distress
6 month change from Baseline
|
-0.6 score on a scale
Standard Deviation 0.9
|
-0.2 score on a scale
Standard Deviation 0.7
|
|
Change in Glaucoma-related Distress
Baseline
|
2.5 score on a scale
Standard Deviation 0.9
|
2.4 score on a scale
Standard Deviation 0.8
|
|
Change in Glaucoma-related Distress
6 months
|
1.9 score on a scale
Standard Deviation 0.8
|
2.2 score on a scale
Standard Deviation 0.9
|
Adverse Events
Enhanced Care Control
SEE Intervention - Personalized Glaucoma Coaching
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Enhanced Care Control
n=118 participants at risk
Enhanced Care Control: Participants will receive non-tailored educational materials about glaucoma from leading sources by mail every 2 months for a total of 3 mailings during the 6-month study period.
|
SEE Intervention - Personalized Glaucoma Coaching
n=117 participants at risk
SEE Intervention - Personalized Glaucoma Coaching: This is a six-month personalized glaucoma coaching program where a coach trained in motivational interviewing (MI)-based counseling uses a web based tool that generates tailored education to help glaucoma patients identify their barriers to optimal medication adherence and explore potential solutions during three in-person coaching sessions. The coach provides between-session support through four phone calls, with two phone calls between the first and second session and one phone call after each subsequent session. Participants can elect to receive any of the following type of alarm when a dose of medication is due: visual or audible alert or automated text or phone call reminder.
|
|---|---|---|
|
Eye disorders
High Intraocular Pressure (IOP)
|
5.9%
7/118 • Number of events 118 • 6 months
IOP was checked five times in the intervention group and twice in the control group.
|
15.4%
18/117 • Number of events 117 • 6 months
IOP was checked five times in the intervention group and twice in the control group.
|
Additional Information
Dr. Paula Anne Newman-Casey
University of Michigan Medical School
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place