Personalized Glaucoma Coaching for Glaucoma

(SEE Trial)

No longer 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a personalized coaching program, called Personalized Glaucoma Coaching, helps glaucoma patients adhere to their eye drop routines more effectively than standard care with educational materials. The coaching includes sessions with a trained advisor who assists patients in overcoming obstacles to regular medication use. Patients with glaucoma or suspected glaucoma who take and manage their own eye drop medication are suitable candidates. The study also examines whether this coaching reduces stress related to managing glaucoma. As an unphased trial, it offers patients the chance to explore innovative support methods to enhance treatment adherence and reduce stress.

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 prior data suggests that the Personalized Glaucoma Coaching Program is safe?

Research shows that the Support, Educate, Empower (SEE) personalized Glaucoma Coaching Program helps people with glaucoma take their eye drop medication more regularly. The program uses motivational conversations and tailored education. Studies have found that participants in the SEE program significantly improved in following their medication schedules.

The program includes in-person coaching sessions and follow-up phone calls. Reports indicate no harmful side effects from this type of coaching. It is a non-medical approach, focusing mainly on providing support and education to help people adhere to their treatment plan.

Therefore, the SEE program appears safe, with no known risks from the coaching itself. Participants can expect assistance in managing their treatment without concerns about safety issues from the program. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Personalized Glaucoma Coaching because it offers a new approach to improving medication adherence for glaucoma patients. Unlike the standard of care options like medicated eye drops or surgeries that focus primarily on treating the condition itself, this coaching program targets the human behavior aspect of treatment. By using motivational interviewing and tailored education, it helps patients overcome personal barriers to taking their medications consistently. This personalized support, combined with reminders like visual or audible alerts, aims to ensure patients stick to their medication schedules, potentially leading to better overall management of their glaucoma.

What evidence suggests that the Personalized Glaucoma Coaching program is effective for improving medication adherence in glaucoma patients?

Research has shown that personalized coaching for glaucoma, which participants in this trial may receive, helps patients take their medication more consistently. Patients who received this coaching reported increased confidence in managing their condition. One study found that even a year after the coaching ended, patients maintained better medication habits than before they started. This suggests that the coaching program can lead to lasting improvements in how patients manage their eye health. ^{1 6 7 8 9}

Who Is on the Research Team?

Paula Newman-Casey, MD MS

Principal Investigator

University of Michigan

Suzanne Winter, MS

Principal Investigator

University of Michigan

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40387429/

Glaucoma Patient Perspectives on Effective Coaching for ... In semi-structured exit interviews, participants in a personalized glaucoma coaching program reported improved self-efficacy in managing their disease.

2. journals.lww.com journals.lww.com/glaucomajournal/abstract/9900/glaucoma_patient_perspectives_on_effective.562.aspx

Glaucoma Patient Perspectives on Effective Coaching for Self In semi-structured exit interviews, participants in a personalized glaucoma coaching program reported improved self-efficacy in managing their disease.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10023277/

The Support, Educate, Empower (SEE) Personalized ... This study is a two-site randomized controlled trial enrolling 230 participants with poor self-reported glaucoma medication adherence.

4. ophthalmologyglaucoma.org ophthalmologyglaucoma.org/article/S2589-4196(20)30209-X/fulltext

Impact of the Support, Educate, Empower Personalized ... The 38 participants completed the Eye Drop Technique Self-Efficacy Scale (EDTSES) at baseline and then again 1 month after the glaucoma ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S258941962200151X

Glaucoma Medication Adherence 1 Year after the Support, ... Glaucoma medication adherence decreased significantly in the year after cessation of the SEE coaching program but remained significantly higher than baseline ...

6. sciencedirect.com sciencedirect.com/science/article/abs/pii/S2589419620301083

Ophthalmology Glaucoma The SEE program participants showed clinically meaningful, statistically significant improvement in glaucoma medication adherence.

7. trialx.com trialx.com/clinical-trials/listings/271451/the-support-educate-empower-see-program/

The Support, Educate, Empower (SEE) Program As a secondary outcome, the study will test whether glaucoma related distress decreases among SEE program participants compared to the control ...

8. stacks.cdc.gov stacks.cdc.gov/view/cdc/129450

Glaucoma Medication Adherence One Year After the ... The largest monthly losses occurred at months 1 (mean=7%, p=0.0001) and 4 (mean=6%, p=0.0077). Conclusions: Glaucoma medication adherence decreased ...

9. ophthalmologyglaucoma.org ophthalmologyglaucoma.org/article/S2589-4196(22)00151-X/fulltext

Glaucoma Medication Adherence 1 Year after the Support ... In conclusion, participants who underwent the SEE personalized glaucoma coaching program had improved glaucoma medication adherence 1 year after ...