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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04274764
Other study ID # HUM00169371
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date July 28, 2020
Est. completion date March 1, 2025

Study information

Verified date March 2023
Source University of Michigan
Contact Suzanne Winter, MS
Phone 7342328185
Email wsuzanne@med.umich.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 400
Est. completion date March 1, 2025
Est. primary completion date March 1, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years to 99 Years
Eligibility Inclusion Criteria: - > or = to 18 years of age Exclusion Criteria: - Sudden vision changes - Significant eye pain - Pregnant women - Prisoners - Cognitive impairment

Study Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
United States Hamilton Community Health Clinic Flint Michigan
United States Hope Clinic Ypsilanti Michigan

Sponsors (2)

Lead Sponsor Collaborator
University of Michigan Centers for Disease Control and Prevention

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Physician Follow up Participant was seen by an Ophthalmologist for needed follow up care within 6 months of recommended appointment time. 6 months
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