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Personalized Glaucoma Coaching for Glaucoma (SEE Trial)

N/A
Waitlist Available
Led By Paula Newman-Casey, MD MS
Research Sponsored by University of Michigan
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights

SEE Trial Summary

This trial will test a new program to help glaucoma patients better follow their eye drop medication regimen. The program provides personalized education and counseling to patients in an effort to improve adherence and decrease glaucoma-related distress.

Who is the study for?
This trial is for English-speaking glaucoma patients who are currently using eye drop medication and have not had recent or planned glaucoma surgery. It's not suitable for those with cognitive impairments, serious mental illnesses like schizophrenia, active eye infections, uveitis, or who can't manage their own eye drops.Check my eligibility
What is being tested?
The SEE Program offers personalized coaching to help improve how well patients stick to their glaucoma medication routine compared to just getting extra educational materials. The program includes motivational talks and education from a non-doctor coach.See study design
What are the potential side effects?
Since this trial focuses on coaching rather than new medications, there aren't direct side effects from the intervention itself. However, any changes in adherence to existing medications could potentially alter the effectiveness or side effect profile of those drugs.

SEE Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Mean electronically monitored medication adherence at six months
Proportion of patients that are ≥80% adherent to their glaucoma medications by electronic monitoring will be compared at 6 months between the intervention and control groups.
Secondary outcome measures
Glaucoma-related Distress

SEE Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Personalized Glaucoma CoachingExperimental Treatment1 Intervention
This is a six-month personalized glaucoma coaching program where a coach trained in motivational interviewing (MI)-based counseling uses a web-based tool that generates tailored education to help glaucoma patients identify their barriers to optimal medication adherence and explore potential solutions during three in-person coaching sessions. The coach provides between-session support through four phone calls, with two phone calls between the first and second sessions and one call after each subsequent session. Participants can elect to receive any of the following types of alarm when a dose of medication is due: visual or audible alert or automated text or phone call reminder. Glaucoma medication adherence will be monitored electronically for all participants between the baseline visit and the exit visit six months later.
Group II: Enhanced standard careActive Control1 Intervention
Participants will receive non-tailored educational materials about glaucoma from leading sources by mail every 2 months for a total of 3 mailings during the 6-month study period. Glaucoma medication adherence will be monitored electronically for all participants between the baseline visit and the exit visit six months later.

Find a Location

Who is running the clinical trial?

University of MichiganLead Sponsor
1,796 Previous Clinical Trials
6,377,717 Total Patients Enrolled
7 Trials studying Glaucoma
1,266 Patients Enrolled for Glaucoma
National Eye Institute (NEI)NIH
546 Previous Clinical Trials
1,401,692 Total Patients Enrolled
41 Trials studying Glaucoma
13,165 Patients Enrolled for Glaucoma
Suzanne Winter, MSStudy DirectorUniversity of Michigan

Media Library

Personalized Glaucoma Coaching Clinical Trial Eligibility Overview. Trial Name: NCT04735653 — N/A
Glaucoma Research Study Groups: Personalized Glaucoma Coaching, Enhanced standard care
Glaucoma Clinical Trial 2023: Personalized Glaucoma Coaching Highlights & Side Effects. Trial Name: NCT04735653 — N/A
Personalized Glaucoma Coaching 2023 Treatment Timeline for Medical Study. Trial Name: NCT04735653 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there vacancies available for participation in this clinical trial?

"According to the information provided on clinicaltrials.gov, this trial is actively seeking candidates for participation. It was first announced online on April 27th 2021 and has since undergone updates as recently as April 15th 2022."

Answered by AI

How many individuals is this clinical research recruiting?

"Affirmative, the clinicaltrials.gov page for this trial indicates that it is currently enrolling participants with a first post date of April 27th 2021 and an update on April 15th 2022. This study requires 230 individuals from 2 sites to take part in the investigation."

Answered by AI
~18 spots leftby Aug 2024