The Support, Educate, Empower (SEE) Program

Glaucoma Clinical Trial

— SEE  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04735653
• Other study ID #: HUM00188154
• Secondary ID: 1R01EY031337-01
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 27, 2021
• Est. completion date: August 15, 2024

Study information

• Verified date: March 2024
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 236
• Est. completion date: August 15, 2024
• Est. primary completion date: August 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Glaucoma

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan
United States	Henry Ford Hospital	Detroit	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
University of Michigan	National Eye Institute (NEI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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