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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01EY031337-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Eye Institute (NEI) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Personalized Glaucoma Coaching | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | Up to 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Paula Newman-Casey, MD MS | University of Michigan | Principal Investigator |
| Suzanne Winter, MS | University of Michigan | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan | Ann Arbor | Michigan | 48109 | United States | ||
| Henry Ford Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41746659 | Derived | 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. |
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236 participants were consented. 235 were randomized. The unrandomized individual was determined to be ineligible post-consenting.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Data is shown for participants who provided data for this outcome. | Posted | Mean | Standard Deviation | percent adherence | Up to 6 months |
|
6 months
IOP was checked five times in the intervention group and twice in the control group.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| High Intraocular Pressure (IOP) | Eye disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Paula Anne Newman-Casey | University of Michigan Medical School | 734-763-6967 | panewman@med.umich.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 19, 2024 | Aug 15, 2025 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Nov 20, 2023 | Aug 27, 2025 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D005901 | Glaucoma |
| D055118 | Medication Adherence |
| ID | Term |
|---|---|
| D009798 | Ocular Hypertension |
| D005128 | Eye Diseases |
| D010349 | Patient Compliance |
| D010342 | Patient Acceptance of Health Care |
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|
| Enhanced Standard care | Behavioral | 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. |
|
| 6 months |
| Detroit |
| Michigan |
| 48202 |
| United States |
| Death |
|
| Removed due to determination of participant noncompliance |
|
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex/Gender, Customized | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| OG000 |
| 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. |
| OG001 | 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. |
|
|
|
| Primary | 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. | Data is shown for participants who provided data for this outcome. | Posted | Count of Participants | Participants | Up to 6 months |
|
|
|
|
| Secondary | 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. | Data is reported for people who came to the exit visit and provided both baseline and 6-month data | Posted | Mean | Standard Deviation | score on a scale | 6 months |
|
|
|
|
| 0 |
| 117 |
| 0 |
| 117 |
| 18 |
| 117 |
| EG001 | 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. | 2 | 118 | 0 | 118 | 7 | 118 |
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| D000074822 |
| Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |
| 6 month change from Baseline |
|