The Support, Educate, Empower (SEE) Program

University of Michigan236 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

SINGLE

Enrollment

236

Conditions

Glaucoma

Interventions

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 careBEHAVIORAL

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (2)

University of Michigan

Ann Arbor, Michigan, United States

Henry Ford Hospital

Detroit, Michigan, United States

Outcomes

Primary Outcomes

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.

Time frame: Up to 6 months

Percentage of Participants Who Achieved >= 80% Medication Adherence Over the 6 Month Study Period

Time frame: Up to 6 months

Secondary Outcomes

Change in Glaucoma-related Distress

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.

Time frame: 6 months