GlaucomaSEENCT04735653

The Support, Educate, Empower (SEE) Program

A study testing Personalized Glaucoma Coaching in people with Glaucoma, run by University of Michigan at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Glaucoma
What is being tested?: Personalized Glaucoma Coaching
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 236 participants
Where: 2 sitesUnited States
Study dates: 27 Apr 2021to 31 Jul 2024
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Taking greater or equal to 1 ocular hypotensive medication with a diagnosis of any kind of glaucoma, suspected glaucoma or ocular hypertension
Did not opt-out from recruitment letter

Who cannot join

Do not speak English
Have a diagnosed serious mental illness (for example, Schizophrenia)
Diagnosed cognitive impairment
Do not instill their own eye drops
Had laser or incisional glaucoma surgery within three months of enrollment or scheduled during the six-month study period
Unable to attend all study visits
Active ocular infection or uveitis

Trial locations and contacts

2 sites in 1 country.

United States2 sites

University of Michigan
Ann Arbor, Michigan, 48109
Henry Ford Hospital
Detroit, Michigan, 48202

Other trials in United States

About this study

Official title: Support, Educate, Empower: The SEE Personalized Glaucoma Coaching Trial

This study will test whether the Support, Educate, Empower (SEE) personalized Glaucoma Coaching Program improves eye drop medication adherence among glaucoma patients compared to enhanced standard care in a randomized controlled clinical trial. As a secondary outcome, the study will test whether glaucoma related distress decreases among SEE program participants compared to the control group.

The study hypothesis is that glaucoma patients with poor adherence who receive motivational-interviewing based counseling and personalized education from a trained non-physician glaucoma coach through the SEE Program will improve their medication adherence compared to glaucoma patients standard care enhanced by additional educational handouts.

Conditions: Glaucoma
Being tested: Personalized Glaucoma Coaching, Enhanced Standard care
Keywords: Ophthalmology, Glaucoma, Medication Adherence, Motivational Interviewing, Tailored Education, Self Management
Medical subject headings: Glaucoma, Medication Adherence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Personalized Glaucoma CoachingBehavioural
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. Glaucoma medication adherence will be monitored electronically for all participants between the baseline visit and the exit visit six months later.
Enhanced Standard careBehavioural
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. Glaucoma medication adherence will be monitored electronically for all participants between the baseline visit and the exit visit six months later.

Study groups in NCT04735653
Study group	Role	What they receive
Personalized Glaucoma Coaching	Experimental	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 sessions and one call after each subsequent session. Participants can elect to receive any of the following types of alarm when a dose of medication is due: visual or audible alert or automated text or phone call reminder. Glaucoma medication adherence will be monitored electronically for all participants between the baseline visit and the exit visit six months later. Receives: Behavioral: Personalized Glaucoma Coaching
Enhanced standard care	Active comparator	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. Glaucoma medication adherence will be monitored electronically for all participants between the baseline visit and the exit visit six months later. Receives: Behavioral: Enhanced Standard care

What is being measured

The primary outcome is the main question the study is designed to answer.

Mean Percent Electronically Monitored Medication Adherence Over Six Months
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.
Measured: Up to 6 months
Percentage of Participants Who Achieved >= 80% Medication Adherence Over the 6 Month Study Period
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.
Measured: Up to 6 months

Secondary outcomes (1)

Change in Glaucoma-related Distress
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.
Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

27 Apr 202131 Jul 2024

First posted3 Feb 2021
Study start27 Apr 2021
Primary completion31 Jul 2024
Study completion31 Jul 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for GlaucomaStudies of the same condition, open and under way.
More trials run by University of MichiganThe sponsor's other registered studies.
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: Single blind
Who is masked: Outcomes assessor
Enrolment: 236 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04735653
Sponsor's protocol ID: HUM00188154
Other IDs: 1R01EY031337-01
Acronym: SEE
Status last verified: Oct 2025
First submitted: 28 Jan 2021
Last updated: 3 Nov 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Newman-Casey PA, Niziol LM, Lu MC, Darnley-Fisch D, Imami N, Mitchell J, MacKenzie C, Heisler M. Effect of the Support, Educate, Empower Personalized Glaucoma Coaching Program on Medication Adherence: The SEE Program Randomized Clinical Trial. JAMA Ophthalmol. 2026 Apr 1;144(4):299-306. doi: 10.1001/jamaophthalmol.2026.0001.
PubMed 41746659

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Glaucoma trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Support, Educate, Empower: The SEE Personalized Glaucoma Coaching Trial
ClinicalTrials.gov ID: NCT04735653
Acronym / sponsor ID: SEE / HUM00188154
Conditions: Glaucoma
Keywords: Ophthalmology, Glaucoma, Medication Adherence, Motivational Interviewing, Tailored Education, Self Management
Study type: Interventional
Recruitment status: Completed
Enrolment: 236 participants (actual)
Lead sponsor: University of MichiganUniversity, hospital or other
Collaborators: National Eye Institute (NEI)
Study start: 27 Apr 2021 (actual)
Primary completion: 31 Jul 2024 (actual)
Study completion: 31 Jul 2024 (actual)
First posted: 3 Feb 2021 (actual)
Results: Posted 3 Nov 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Health services research
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Personalized Glaucoma Coaching	Experimental	Behavioral: Personalized Glaucoma CoachingThis 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 sessions and one call after each subsequent session. Participants can elect to receive any of the following types of alarm when a dose of medication is due: visual or audible alert or automated text or phone call reminder. Glaucoma medication adherence will be monitored electronically for all participants between the baseline visit and the exit visit six months later.
Enhanced standard care	Active comparator	Behavioral: Enhanced Standard careParticipants 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. Glaucoma medication adherence will be monitored electronically for all participants between the baseline visit and the exit visit six months later.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Taking greater or equal to 1 ocular hypotensive medication with a diagnosis of any kind of glaucoma, suspected glaucoma or ocular hypertension
Did not opt-out from recruitment letter

Key exclusion criteria (7 listed)

Do not speak English
Have a diagnosed serious mental illness (for example, Schizophrenia)
Diagnosed cognitive impairment
Do not instill their own eye drops
Had laser or incisional glaucoma surgery within three months of enrollment or scheduled during the six-month study period

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
Personalized Glaucoma CoachingThis 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. Glaucoma medication adherence will be monitored electronically for all participants between the baseline visit and the exit visit six months later.	Behavioural	Personalized Glaucoma Coaching
Enhanced Standard careParticipants 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. Glaucoma medication adherence will be monitored electronically for all participants between the baseline visit and the exit visit six months later.	Behavioural	Enhanced standard care

Primary outcome

Mean Percent Electronically Monitored Medication Adherence Over Six Months
Time frame: Up to 6 months
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.
Percentage of Participants Who Achieved >= 80% Medication Adherence Over the 6 Month Study Period
Time frame: Up to 6 months
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.

1 secondary outcome

Change in Glaucoma-related Distress
Time frame: 6 months

Results and safety

Results posted to the registry on 3 Nov 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
SEE Intervention - Personalized Glaucoma Coaching	117	90
Enhanced Care Control	118	107

Primary outcome: Mean Percent Electronically Monitored Medication Adherence Over Six Months

Time frame: Up to 6 months. Mean (Standard Deviation). Unit: percent adherence

Measure	SEE Intervention - Personalized Glaucoma Coaching n = 113	Enhanced Care Control n = 114
Value	77.6 (19.7)	58.0 (25.2)

SEE Intervention - Personalized Glaucoma Coaching vs Enhanced Care Control: p <0.001, Wilcoxon (Mann-Whitney)

Population analysed: Data is shown for participants who provided data for this outcome.

Primary outcome: Percentage of Participants Who Achieved >= 80% Medication Adherence Over the 6 Month Study Period

Time frame: Up to 6 months. Count of participants. Unit: Participants

Measure	SEE Intervention - Personalized Glaucoma Coaching n = 113	Enhanced Care Control n = 114
Adherence >= 80%	62	27
Adherence < 80%	51	87

SEE Intervention - Personalized Glaucoma Coaching vs Enhanced Care Control: p <0.001, Chi-squared

Population analysed: Data is shown for participants who provided data for this outcome.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 6 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
SEE Intervention - Personalized Glaucoma Coaching	0 of 117 (0%)	18 of 117 (15.4%)	0 of 117
Enhanced Care Control	0 of 118 (0%)	7 of 118 (5.9%)	2 of 118

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 41746659Newman-Casey PA, Niziol LM, Lu MC, Darnley-Fisch D, Imami N, Mitchell J, MacKenzie C, Heisler M. Effect of the Support, Educate, Empower Personalized Glaucoma Coaching Program on Medication Adherence: The SEE Program Randomized Clinical Trial. JAMA Ophthalmol. 2026 Apr 1;144(4):299-306. doi: 10.1001/jamaophthalmol.2026.0001.
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.

Paula Newman-Casey, MD MS principal investigator

University of Michigan

Suzanne Winter, MS study director

University of Michigan

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Personalized Glaucoma Coaching in people with Glaucoma, run by University of Michigan at 2 sites 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 2 inclusion and 7 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: finished, as of the sponsor's last update on 3 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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?

Yes. Results are posted in the registry (first posted 3 Nov 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Mean Percent Electronically Monitored Medication Adherence Over Six Months (time frame: Up to 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04735653, which also lists 1 linked publication.

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 3 Nov 2025.