The Support, Educate, Empower (SEE) Program (SEE)

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

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 Overview

• Status: Active, not recruiting
• Conditions: Glaucoma
• Intervention / Treatment: Behavioral: Personalized Glaucoma Coaching; Behavioral: Enhanced Standard care

• Study Type: Interventional
• Enrollment (Actual): 236
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Phalatha McHaney-Conner; Phone Number: 734-232-8057; Email: pmchaney@umich.edu
• Study Contact Backup: Name: Suzanne Winter, MS; Phone Number: 734-232-8185; Email: wsuzanne@umich.edu

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan
    • Detroit, Michigan, United States, 48202
      • Henry Ford Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Personalized Glaucoma Coaching; 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; 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.
Active Comparator: Enhanced standard care; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean electronically monitored medication adherence at 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 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.	Up to 6 months
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

Outcome Measure	Measure Description	Time Frame
Glaucoma-related Distress	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.	6 months

Collaborators and Investigators

• Sponsor: University of Michigan
• Collaborators: National Eye Institute (NEI)
• Investigators: Principal Investigator: Paula Newman-Casey, MD MS, University of Michigan; Study Director: Suzanne Winter, MS, University of Michigan

Study record dates

Study Major Dates

• Study Start (Actual): April 27, 2021
• Primary Completion (Estimated): August 15, 2024
• Study Completion (Estimated): August 15, 2024

Study Registration Dates

• First Submitted: January 28, 2021
• First Submitted That Met QC Criteria: January 28, 2021
• First Posted (Actual): February 3, 2021

Study Record Updates

• Last Update Posted (Actual): March 19, 2024
• Last Update Submitted That Met QC Criteria: March 15, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Motivational Interviewing; Glaucoma; Medication Adherence; Ophthalmology; Self Management; Tailored Education
• Additional Relevant MeSH Terms: Eye Diseases; Ocular Hypertension; Glaucoma
• Other Study ID Numbers: HUM00188154; 1R01EY031337-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No