Screening and Intervention for Glaucoma and Eye Health Through Telemedicine

Not Applicable

Completed

• Conditions: Glaucoma

• Registration Number: NCT04274764
• Lead Sponsor: University of Michigan

Brief Summary

This is a multiple site, randomized study that will assess the effects of personalized eHealth education and motivational-interviewing-based counseling on patient adherence to physician follow-up appointments.

Detailed Description

The primary objective of this study is to evaluate the effects of personalized eHealth education and motivational-interviewing-based counseling on adherence to glaucoma follow-up care compared to standard education delivered by a trained staff member. Participants will be randomized in a 1:1 ratio to either standard education and care navigation or eHealth education, counseling and care navigation. The outcome measure of the participant seeing an Ophthalmologist for follow up care within 3 months was increased to 6 months. This modification was made due to ophthalmology visit appointments not being available within the 3-month timeframe.

This study is embedded in a CDC-funded program to engage people from medically underserved areas in glaucoma screening. Participants who screened positive for glaucoma or suspected glaucoma were randomized in a 1:1 ratio to either the standard education and care navigation arm or the eHealth education, counseling, and care navigation arm.

Study Timeline

• Study First Submitted: 2020-02-14
• Study First Submitted QC: 2020-02-14
• Study First Posted: 2020-02-18
• Study Start: 2020-07-28
• Primary Completion: 2024-03-28
• Study Completion: 2024-03-28
• Results First Submitted: 2025-02-03
• Status Verified: 2025-03
• Results First Submitted QC: 2025-03-17
• Last Update Submitted: 2025-03-17
• Results First Posted: 2025-03-20
• Last Update Posted: 2025-03-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 622

Inclusion Criteria

• > or = to 18 years of age

Exclusion Criteria

• Sudden vision changes
• Significant eye pain
• Pregnant women
• Prisoners
• Cognitive impairment

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Physician Follow up	Up to 18 months	Results reflect the count of participants who were seen by an ophthalmologist for follow-up care within 6 months of their recommended appointment time, and those who did not attend the scheduled follow-up appointment.

Trial Locations

Locations (2)

Hamilton Community Health Clinic; 🇺🇸 Flint, Michigan, United States

Hope Clinic; 🇺🇸 Ypsilanti, Michigan, United States