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Completed

NCT Number: NCT04735653

The Support, Educate, Empower (SEE) Program

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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Key information

Conditions

Glaucoma Behavior Eye Diseases Health Behavior Medication Adherence Ocular Hypertension Patient Acceptance of Health Care Patient Compliance Treatment Adherence and Compliance

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Michigan, Ann Arbor, Michigan, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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.

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.

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. Change in Glaucoma-related Distress

    Time frame: 6 months

    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.

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Collaborators

  • National Eye Institute (NEI)

Registry information

Official study title

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

Acronym: SEE

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Feb 3, 2021
Registry last updated
Nov 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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