The Support, Educate, Empower (SEE) Program

Not Applicable

Active, not recruiting

• Conditions: Glaucoma

• Registration Number: NCT04735653
• Lead Sponsor: University of Michigan

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-01-28
• Study First Submitted QC: 2021-01-28
• Study First Posted: 2021-02-03
• Study Start: 2021-04-27
• Primary Completion: 2024-08-30
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-03
• Last Update Posted: 2025-02-04
• Study Completion: 2025-08-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 236

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Mean electronically monitored medication adherence at six months	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 proportion of doses taken on time divided by total doses prescribed over the six-month study period. For participants on more than one medication, adherence will be first measured at the medication level and then aggregated to the person level by dividing the total number of doses of all medication(s) taken on time by the total number of doses prescribed. Mean medication adherence will be compared at six months between the intervention and control groups.
Proportion of patients that are ≥80% adherent to their glaucoma medications by electronic monitoring will be compared at 6 months between the intervention and control groups.	Up to 6 months

Secondary Outcome Measures

Name	Time	Method
Glaucoma-related Distress	6 months	Glaucoma-related Distress will be measured by the Diabetes Distress Scale adapted for glaucoma, a 17-item scale where a higher score indicates a higher distress level. Mean Glaucoma-related Distress will be compared at 6 months between the intervention and control groups.

Trial Locations

Locations (2)

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States

Henry Ford Hospital; 🇺🇸 Detroit, Michigan, United States