Clinical Trials Directory

Trials / Completed

CompletedNCT04735653

The Support, Educate, Empower (SEE) Program

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
236 (actual)
Sponsor
University of Michigan · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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

Interventions

TypeNameDescription
BEHAVIORALPersonalized 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.
BEHAVIORALEnhanced 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.

Timeline

Start date
2021-04-27
Primary completion
2024-07-31
Completion
2024-07-31
First posted
2021-02-03
Last updated
2025-11-03
Results posted
2025-11-03

Locations

2 sites across 1 country: United States

Source: ClinicalTrials.gov record NCT04735653. Inclusion in this directory is not an endorsement.