NCT04274764

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
622

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 14, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 18, 2020

Completed
5 months until next milestone

Study Start

First participant enrolled

July 28, 2020

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 28, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 28, 2024

Completed
12 months until next milestone

Results Posted

Study results publicly available

March 20, 2025

Completed
Last Updated

March 20, 2025

Status Verified

March 1, 2025

Enrollment Period

3.7 years

First QC Date

February 14, 2020

Results QC Date

February 3, 2025

Last Update Submit

March 17, 2025

Conditions

Glaucoma

Keywords

TelemedicineMotivational interviewingHealth Coaching

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Personalized eHealth Education & Motivational Interviewing

EXPERIMENTAL

Personalized eHealth Glaucoma Education \& Motivational Interviewing

Behavioral: Personalized eHealth Education & Motivational Interviewing

Standard Education

NO INTERVENTION

Participant will receive standard glaucoma education.

Interventions

Personalized eHealth Education & Motivational InterviewingBEHAVIORAL

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.

Personalized eHealth Education & Motivational Interviewing

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \- \> or = to 18 years of age

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hamilton Community Health Clinic

Flint, Michigan, 48505, United States

Location

Hope Clinic

Ypsilanti, Michigan, 48197, United States

Location

Related Publications (3)

  • 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.

    PMID: 31878800BACKGROUND

  • Flaharty K, Niziol LM, Woodward MA, Elam A, Bicket A, Killeen OJ, Zhang J, Johnson L, Kershaw M, John DA, Wood SK, Musch DC, Newman-Casey PA. Association of Contrast Sensitivity With Eye Disease and Vision-Related Quality of Life. Am J Ophthalmol. 2024 May;261:176-186. doi: 10.1016/j.ajo.2024.01.021. Epub 2024 Jan 26.

    PMID: 38281569DERIVED

  • Newman-Casey PA, Aliancy J, Lu MC, Woodward MA, Hicks PM, Niziol LM, Musch DC, Bicket AK, John D, Killeen O, Wood SD, Johnson L, Kershaw M, Zhang J, Elam AR. Social Deprivation and the Risk of Screening Positive for Glaucoma in the MI-SIGHT Telemedicine-Based Glaucoma Detection Program. Ophthalmology. 2023 Oct;130(10):1053-1065. doi: 10.1016/j.ophtha.2023.05.021. Epub 2023 May 19.

    PMID: 37211338DERIVED

Related Links

MeSH Terms

Conditions

Glaucoma

Interventions

Motivational Interviewing

Condition Hierarchy (Ancestors)

Ocular HypertensionEye Diseases

Intervention Hierarchy (Ancestors)

Directive CounselingCounselingMental Health ServicesBehavioral Disciplines and ActivitiesHealth ServicesHealth Care Facilities Workforce and Services

Results Point of Contact

Title
Paula Anne Newman-Casey
Organization
University of Michigan
panewman@med.umich.edu
734 763-6967

Study Officials

  • Paula Anne Newman-Casey, MD

    University of Michigan

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Participants will be assigned at a 1:1 ratio to the study intervention.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

February 14, 2020

First Posted

February 18, 2020

Study Start

July 28, 2020

Primary Completion

March 28, 2024

Study Completion

March 28, 2024

Last Updated

March 20, 2025

Results First Posted

March 20, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations

US(2)