SIGHT: Screening and Intervention for Glaucoma and Eye Health Through Telemedicine

Sponsor
University of Michigan (Other)
Overall Status
Recruiting
CT.gov ID
NCT04274764
Collaborator
Centers for Disease Control and Prevention (U.S. Fed)
400
Enrollment
2
Locations
2
Arms
55.1
Anticipated Duration (Months)
200
Patients Per Site
3.6
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or DiseaseIntervention/TreatmentPhase
  • Behavioral: Personalized eHealth Education & Motivational Interviewing
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
400 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Participants will be assigned at a 1:1 ratio to the study intervention.Participants will be assigned at a 1:1 ratio to the study intervention.
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Sustainable Community Clinic Telemedicine-Based Glaucoma Screening
Actual Study Start Date :
Jul 28, 2020
Anticipated Primary Completion Date :
Mar 1, 2025
Anticipated Study Completion Date :
Mar 1, 2025

Arms and Interventions

ArmIntervention/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.

Outcome Measures

Primary Outcome Measures

  1. Physician Follow up [3 months]

    Participant was seen by an Ophthalmologist for needed follow up care within 3 months of recommended appointment time.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 99 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • or = to 18 years of age

Exclusion Criteria:
  • Sudden vision changes

  • Significant eye pain

  • Pregnant women

  • Prisoners

  • Cognitive impairment

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1Hamilton Community Health ClinicFlintMichiganUnited States48505
2Hope ClinicYpsilantiMichiganUnited States48197

Sponsors and Collaborators

  • University of Michigan
  • Centers for Disease Control and Prevention

Investigators

  • Principal Investigator: Paula Anne Newman-Casey, MD, University of Michigan

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

Responsible Party:
Paula Anne Newman-Casey, Assistant Professor, University of Michigan
ClinicalTrials.gov Identifier:
NCT04274764
Other Study ID Numbers:
  • HUM00169371
First Posted:
Feb 18, 2020
Last Update Posted:
Sep 10, 2021
Last Verified:
Sep 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Paula Anne Newman-Casey, Assistant Professor, University of Michigan
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 10, 2021