Personalized Glaucoma Coaching for Glaucoma

(SEE Trial)

Recruiting at 1 trial location

Overseen By Paula Newman-Casey, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Michigan

Must be taking: Ocular hypotensives

Disqualifiers: Serious mental illness, Cognitive impairment, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 6 months

236 Participants Needed

Trial Summary

What is the purpose of this trial?

This study will test whether the Support, Educate, Empower (SEE) personalized Glaucoma Coaching Program improves eye drop medication adherence among glaucoma patients compared to enhanced standard care in a randomized controlled clinical trial. As a secondary outcome, the study will test whether glaucoma related distress decreases among SEE program participants compared to the control group. The study hypothesis is that glaucoma patients with poor adherence who receive motivational-interviewing based counseling and personalized education from a trained non-physician glaucoma coach through the SEE Program will improve their medication adherence compared to glaucoma patients standard care enhanced by additional educational handouts.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. It focuses on improving adherence to eye drop medications for glaucoma.

What data supports the effectiveness of the Personalized Glaucoma Coaching treatment?

Research shows that health coaching, like the Support, Educate, Empower (SEE) program, can improve how well patients use their eye drops and stick to their medication schedule, which is crucial for managing glaucoma effectively. ^{1 2 3 4 5}

How is Personalized Glaucoma Coaching different from other treatments for glaucoma?

Personalized Glaucoma Coaching is unique because it focuses on improving patients' ability to properly use their eye drops and boosts their confidence in managing their treatment, which can lead to better adherence to medication. Unlike traditional treatments that focus solely on medication, this approach includes personalized support and education to empower patients in their glaucoma care. ^{2 3 4 6 7}

Research Team

Paula Newman-Casey, MD MS

Principal Investigator

University of Michigan

Suzanne Winter, MS

Principal Investigator

University of Michigan

Eligibility Criteria

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.

Inclusion Criteria

Taking greater or equal to 1 ocular hypotensive medication with a diagnosis of any kind of glaucoma, suspected glaucoma or ocular hypertension

Did not opt-out from recruitment letter

Exclusion Criteria

Had laser or incisional glaucoma surgery within three months of enrollment or scheduled during the six-month study period

Do not instill their own eye drops

Unable to attend all study visits

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive personalized glaucoma coaching or enhanced standard care for 6 months

6 months

3 in-person coaching sessions, 4 phone calls

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Enhanced Standard care
• Personalized Glaucoma Coaching

Trial Overview 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.

Participant Groups

Group I: Personalized Glaucoma Coaching Experimental Treatment 1 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 care Active Control 1 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.

Who Is Running the Clinical Trial?

University of Michigan

Lead Sponsor

Trials

1,891

Recruited

6,458,000+

National Eye Institute (NEI)

Collaborator

Trials

572

Recruited

1,320,000+

References

1. United States pubmed.ncbi.nlm.nih.gov

Impact of patient-held record on knowledge at 1-year follow-up for glaucoma patients: single-center randomized controlled trial. [2018]

2. New Zealand pubmed.ncbi.nlm.nih.gov

Health coaching for glaucoma care: a pilot study using mixed methods. [2020]

3. United States pubmed.ncbi.nlm.nih.gov

Impact of the Support, Educate, Empower Personalized Glaucoma Coaching Program Pilot Study on Eye Drop Instillation Technique and Self-Efficacy. [2022]

4. England pubmed.ncbi.nlm.nih.gov

The Support, Educate, Empower personalized glaucoma coaching trial design. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Glaucoma Medication Adherence 1 Year after the Support, Educate, Empower Personalized Glaucoma Coaching Program. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Personalized Prediction of Glaucoma Progression Under Different Target Intraocular Pressure Levels Using Filtered Forecasting Methods. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Increased Near Activities Function Associated With Increased Glaucoma Medication Adherence Among Support, Educate, Empower (SEE) Participants. [2023]