Screening and Intervention for Glaucoma and Eye Health Through Telemedicine (SIGHT)

Sustainable Community Clinic Telemedicine-Based Glaucoma Screening

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.

Study Overview

• Status: Completed
• Conditions: Glaucoma
• Intervention / Treatment: Behavioral: Personalized eHealth Education & Motivational Interviewing

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 Type: Interventional
• Enrollment (Actual): 622
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Flint, Michigan, United States, 48505
      • Hamilton Community Health Clinic
    • Ypsilanti, Michigan, United States, 48197
      • Hope Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

- > or = to 18 years of age

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Personalized eHealth Education & Motivational Interviewing; Personalized eHealth Glaucoma Education & Motivational Interviewing	Behavioral: Personalized eHealth Education & Motivational Interviewing; This intervention uses a web-based application to generate personalized education materials for patients based on their eye health screening results and barriers to follow up care. A glaucoma counselor trained in brief, glaucoma-specific motivational interviewing (MI) uses the individualized content generated from this web-based application to form the basis of her conversation with the patient to coach the patient to engage in follow-up care.
No Intervention: Standard Education; Participant will receive standard glaucoma education.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Physician Follow up	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.	Up to 18 months

Collaborators and Investigators

• Sponsor: University of Michigan
• Collaborators: Centers for Disease Control and Prevention
• Investigators: Principal Investigator: Paula Anne Newman-Casey, MD, University of Michigan

Publications and helpful links

General Publications

• Newman-Casey PA, Killeen O, Miller S, MacKenzie C, Niziol LM, Resnicow K, Creswell JW, Cook P, Heisler M. A Glaucoma-Specific Brief Motivational Interviewing Training Program for Ophthalmology Para-professionals: Assessment of Feasibility and Initial Patient Impact. Health Commun. 2020 Feb;35(2):233-241. doi: 10.1080/10410236.2018.1557357. Epub 2018 Dec 20.

Helpful Links

• Hope Clinic
• Hamilton Clinic

Study record dates

Study Major Dates

• Study Start (Actual): July 28, 2020
• Primary Completion (Actual): March 28, 2024
• Study Completion (Actual): March 28, 2024

Study Registration Dates

• First Submitted: February 14, 2020
• First Submitted That Met QC Criteria: February 14, 2020
• First Posted (Actual): February 18, 2020

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 17, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: Telemedicine; Motivational interviewing; Health Coaching
• Additional Relevant MeSH Terms: Eye Diseases; Ocular Hypertension; Glaucoma
• Other Study ID Numbers: HUM00169371; 5-U01-DP-006442-05-00 (Other Grant/Funding Number: Centers for Disease Control and Prevention)

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