Screening and Intervention for Glaucoma and Eye Health Through Telemedicine (SIGHT)
Primary Purpose
Glaucoma
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Personalized eHealth Education & Motivational Interviewing
Sponsored by
About this trial
This is an interventional prevention trial for Glaucoma focused on measuring Telemedicine, Motivational interviewing, Health Coaching
Eligibility Criteria
Inclusion Criteria:
- > or = to 18 years of age
Exclusion Criteria:
- Sudden vision changes
- Significant eye pain
- Pregnant women
- Prisoners
- Cognitive impairment
Sites / Locations
- Hamilton Community Health ClinicRecruiting
- Hope ClinicRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Personalized eHealth Education & Motivational Interviewing
Standard Education
Arm Description
Personalized eHealth Glaucoma Education & Motivational Interviewing
Participant will receive standard glaucoma education.
Outcomes
Primary Outcome Measures
Physician Follow up
Participant was seen by an Ophthalmologist for needed follow up care within 6 months of recommended appointment time.
Secondary Outcome Measures
Full Information
NCT ID
NCT04274764
First Posted
February 14, 2020
Last Updated
March 24, 2023
Sponsor
University of Michigan
Collaborators
Centers for Disease Control and Prevention
1. Study Identification
Unique Protocol Identification Number
NCT04274764
Brief Title
Screening and Intervention for Glaucoma and Eye Health Through Telemedicine
Acronym
SIGHT
Official Title
Sustainable Community Clinic Telemedicine-Based Glaucoma Screening
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 28, 2020 (Actual)
Primary Completion Date
March 1, 2025 (Anticipated)
Study Completion Date
March 1, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan
Collaborators
Centers for Disease Control and Prevention
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma
Keywords
Telemedicine, Motivational interviewing, Health Coaching
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants will be assigned at a 1:1 ratio to the study intervention.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
400 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Personalized eHealth Education & Motivational Interviewing
Arm Type
Experimental
Arm Description
Personalized eHealth Glaucoma Education & Motivational Interviewing
Arm Title
Standard Education
Arm Type
No Intervention
Arm Description
Participant will receive standard glaucoma education.
Intervention Type
Behavioral
Intervention Name(s)
Personalized eHealth Education & Motivational Interviewing
Intervention Description
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.
Primary Outcome Measure Information:
Title
Physician Follow up
Description
Participant was seen by an Ophthalmologist for needed follow up care within 6 months of recommended appointment time.
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
- > or = to 18 years of age
Exclusion Criteria:
Sudden vision changes
Significant eye pain
Pregnant women
Prisoners
Cognitive impairment
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Suzanne Winter, MS
Phone
7342328185
Email
wsuzanne@med.umich.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Phalatha McHaney-Connor
Phone
7342328057
Email
pmchaney@med.umich.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paula Anne Newman-Casey, MD
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hamilton Community Health Clinic
City
Flint
State/Province
Michigan
ZIP/Postal Code
48505
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Manager
Phone
810-406-4246
Email
sthompson@hamiltonchn.org
First Name & Middle Initial & Last Name & Degree
Paula Anne Newman-Casey, MD
Facility Name
Hope Clinic
City
Ypsilanti
State/Province
Michigan
ZIP/Postal Code
48197
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Manager
Phone
734-484-2989
Email
apeterson@thehopeclinic.org
First Name & Middle Initial & Last Name & Degree
Paula Anne Newman-Casey, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
31878800
Citation
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.
Results Reference
background
Links:
URL
https://thehopeclinic.org/
Description
Hope Clinic
URL
https://www.hamiltonchn.org/main-clinic/
Description
Hamilton Clinic
Learn more about this trial
Screening and Intervention for Glaucoma and Eye Health Through Telemedicine
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