The Support, Educate, Empower (SEE) Program

NCT04735653 | Completed Results

• 2 other identifiers: HUM001881541R01EY031337-01
• Study Type: interventional
• Target: 236
• Locations: 1 country
• Sites: 2

Brief Summary

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

Keywords

Ophthalmology; Glaucoma; Medication Adherence; Motivational Interviewing; Tailored Education; Self Management

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (1)

• Change in Glaucoma-related Distress

  6 months

Study Arms (2)

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.

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.

Behavioral: Enhanced Standard care

Interventions

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.

Personalized Glaucoma Coaching

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.

Enhanced standard care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Michigan: lead
• National Eye Institute (NEI): collaborator

Study Sites (2)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Henry Ford Hospital

Detroit, Michigan, 48202, United States

Location

MeSH Terms

Conditions

Glaucoma; Medication Adherence

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Dr. Paula Anne Newman-Casey
• Organization: University of Michigan Medical School

panewman@med.umich.edu

734-763-6967

Study Officials

• Paula Newman-Casey, MD MS

  University of Michigan

  PRINCIPAL INVESTIGATOR

• Suzanne Winter, MS

  University of Michigan

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Ophthalmology and Visual Sciences

Study Record Dates

• First Submitted: January 28, 2021
• First Posted: February 3, 2021
• Study Start: April 27, 2021
• Primary Completion: July 31, 2024
• Study Completion: July 31, 2024
• Last Updated: November 3, 2025
• Results First Posted: November 3, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)