The Support, Educate, Empower (SEE) Program

University of Michigan

Status: Completed

Conditions: Glaucoma

Treatments: Behavioral: Enhanced Standard care; Behavioral: Personalized Glaucoma Coaching

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04735653

HUM00188154

1R01EY031337-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 236 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

236 participants in 2 patient groups

Personalized Glaucoma Coaching

Experimental group

Description:

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.

Treatment:

Behavioral: Personalized Glaucoma Coaching

Enhanced standard care

Active Comparator group

Description:

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.

Treatment:

Behavioral: Enhanced Standard care