Telemedicine Interventions for Glaucoma

(SIGHT Trial)

No longer recruiting at 1 trial location

Overseen By Phalatha McHaney-Connor

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Michigan

Disqualifiers: Vision changes, Eye pain, Pregnancy, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores new methods to help glaucoma patients attend follow-up appointments with their doctors. It tests whether personalized online education and motivational counseling improve appointment attendance compared to standard education. People with glaucoma who do not experience sudden vision changes or significant eye pain might be suitable candidates. Participants will receive either personalized eHealth education and motivational counseling or standard glaucoma education. As an unphased trial, this study provides a unique opportunity for patients to contribute to innovative strategies that could enhance their healthcare experience.

Do I need to stop my current medications for this trial?

The trial protocol does not specify whether you need to stop your current medications.

What prior data suggests that this telemedicine intervention is safe for glaucoma patients?

Research has shown that personalized online health education and motivational talks are generally safe. In one study, participants received counseling sessions and phone calls, with no reports of negative side effects. These sessions helped people consistently take their glaucoma medication. Another study found similar results, with participants improving their medication habits without safety concerns. Based on current evidence, these methods appear safe and well-tolerated. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about telemedicine interventions for glaucoma because they offer a personalized approach that goes beyond standard educational methods. Unlike traditional glaucoma care that primarily involves in-office visits and standard education, this new method leverages personalized eHealth education combined with motivational interviewing. This approach not only provides tailored information to suit individual patient needs but also actively engages patients to improve their adherence to treatment plans. By using technology to enhance patient education and motivation, this intervention has the potential to significantly improve patient outcomes and access to care.

What evidence suggests that this trial's treatments could be effective for glaucoma?

This trial will compare Personalized eHealth Education & Motivational Interviewing with Standard Education for glaucoma patients. Research has shown that personalized online health education, combined with motivational conversations, can help people with glaucoma take their medication on time. One study found that participants using these personalized programs followed their medication schedules more effectively. Another study showed that patients felt more confident about using their eye drops correctly. These programs aim to educate and empower patients, making it easier for them to manage their condition. While researchers continue to study this approach, early results are promising for helping glaucoma patients adhere to their treatment plans. ^{4 5 6 7 8}

Who Is on the Research Team?

Paula Anne Newman-Casey, MD

Principal Investigator

University of Michigan

Are You a Good Fit for This Trial?

This trial is for adults over 18 with glaucoma. It's not suitable for those experiencing sudden vision changes, significant eye pain, pregnant women, prisoners, or individuals with cognitive impairments.

Exclusion Criteria

I have difficulty with memory or thinking clearly.

Prisoners

I am experiencing severe eye pain.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive either personalized eHealth education and motivational interviewing or standard education and care navigation

6 months

Follow-up

Participants are monitored for adherence to follow-up care with an ophthalmologist

Up to 18 months

What Are the Treatments Tested in This Trial?

Interventions

• Personalized eHealth Education & Motivational Interviewing

Trial Overview

The study is testing whether personalized eHealth education and motivational interviews can help patients stick to their follow-up appointments with doctors. This research involves multiple sites and randomly assigns participants to different groups.

How Is the Trial Designed?

Group I: Personalized eHealth Education & Motivational Interviewing Experimental Treatment 1 Intervention

Personalized eHealth Glaucoma Education \& Motivational Interviewing

Group II: Standard Education Active Control 1 Intervention

Participant will receive standard glaucoma education.

Who Is Running the Clinical Trial?

University of Michigan

Lead Sponsor

Trials

1,891

Recruited

6,458,000+

Centers for Disease Control and Prevention

Collaborator

Trials

902

Recruited

25,020,000+

Published Research Related to This Trial

A brief, glaucoma-specific motivational interviewing training program for ophthalmic para-professionals was found to be feasible and led to improved patient satisfaction with staff communication, as evidenced by a significant increase in satisfaction scores (p = 0.04).

While para-professionals improved their skills in motivational interviewing, the training did not enhance patients' self-efficacy in eye drop instillation or overall health activation, highlighting the need for dedicated time in clinics to effectively implement these counseling techniques.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Glaucoma-Specific Brief Motivational Interviewing Training Program for Ophthalmology Para-professionals: Assessment of Feasibility and Initial Patient Impact. Newman-Casey, PA., Killeen, O., Miller, S., et al.[2023]

In a study of 201 patients with glaucoma, reminder calls significantly improved medication adherence compared to usual care, as measured by electronic monitoring and self-reports.

Motivational interviewing (MI) did not show a significant effect on adherence but resulted in higher patient satisfaction compared to reminder calls, suggesting that while MI is beneficial for satisfaction, reminder calls may be a more effective and cost-efficient strategy for improving adherence in patients with already high baseline adherence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Motivational interviewing or reminders for glaucoma medication adherence: Results of a multi-site randomised controlled trial. Cook, PF., Schmiege, SJ., Mansberger, SL., et al.[2018]

A glaucoma educator trained in motivational interviewing (MI) was successfully integrated into a busy ophthalmology practice, demonstrating feasibility in improving patient adherence to glaucoma treatment.

Patients who participated in the MI program showed improvements in both motivation and adherence to their medication, suggesting that this approach could be effectively implemented in other clinics to enhance treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of motivational interviewing delivered by a glaucoma educator to improve medication adherence. Cook, PF., Bremer, RW., Ayala, AJ., et al.[2022]

The electronic intervention using QR codes significantly increased awareness and discussions about glaucoma risk among first-degree relatives (FDRs) of patients, with 95% of FDRs engaging in conversations after receiving the standard message.

Following the intervention, 59% of FDRs scheduled glaucoma screening appointments, indicating that the method effectively encouraged proactive health behavior regarding glaucoma screening.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Empowering Family Glaucoma Risk Communication Using QR-Code-Mediated Online Intervention. Hallaj, S., Shah, SJ., Cehelyk, EK., et al.[2023]

The SEE personalized glaucoma coaching program was well-received by 39 participants, with 95% expressing positive views, highlighting the effectiveness of personalized education and motivational support in improving medication adherence.

Key components that contributed to better adherence included interactions with a glaucoma coach, personalized education, and electronic reminders, with those showing greater improvement in adherence feeling a stronger need to improve and trusting their adherence scores more.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient Experience during the Support, Educate, Empower Glaucoma Coaching Program to Improve Medication Adherence: A Pilot Study. Hollenhorst, CN., Elliott, V., Heisler, M., et al.[2021]

This pilot study aims to improve medication adherence in glaucoma patients by using a combination of reminder systems and motivational interviewing, enrolling 57 participants who have shown poor adherence to their medications.

Over a 2-year period, the intervention includes a 3-month reminder phase followed by a 6-month counseling program, with the primary goal of increasing adherence and assessing its impact on clinical outcomes like intraocular pressure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Personalized behavior change program for glaucoma patients with poor adherence: a pilot interventional cohort study with a pre-post design. Newman-Casey, PA., Niziol, LM., Mackenzie, CK., et al.[2022]

In a randomized controlled trial involving 276 glaucoma patients in Nigeria, adapted motivational interviewing (MI) led to a 52% uptake of surgery or laser treatment, compared to 45% in the usual care group, indicating a slight increase in treatment acceptance.

Although the increase in treatment uptake with MI was not statistically significant, the overall acceptance rate of 52% is notably higher than in other studies, suggesting that MI may still have a positive impact on patient engagement in treatment decisions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Can Adapted Motivational Interviewing Improve Uptake of Surgical or Laser Treatment for Glaucoma in Nigeria: Randomized Controlled Trial. Abdull, MM., McCambridge, J., Evans, J., et al.[2018]

Citations

1.

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.

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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 ...

3.

trialx.com

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

The Support, Educate, Empower (SEE) Program

This study will test whether the Support, Educate, Empower (SEE) personalized Glaucoma Coaching Program improves eye drop medication adherence ...

4.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/36855233/

The Support, Educate, Empower personalized glaucoma ...

The primary outcome is the proportion of prescribed doses taken on schedule during the 6-month period. The secondary outcome is glaucoma related ...

5.

pilotfeasibilitystudies.biomedcentral.com

pilotfeasibilitystudies.biomedcentral.com/articles/10.1186/s40814-018-0320-6

Personalized behavior change program for glaucoma patients ...

The primary outcome is change in medication adherence. The secondary outcomes include changes in clinical outcomes (intraocular pressure, IOP, ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC6055343/

a pilot interventional cohort study with a pre-post design

Participants will receive 170 min of counseling (one 60-min counseling session, two 30-min counseling sessions, and five 10-min telephone calls) ...

7.

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.

8.

cdn.clinicaltrials.gov

cdn.clinicaltrials.gov/large-docs/64/NCT04274764/Prot_000.pdf

Screening and Intervention for Glaucoma and eye Health ...

We hypothesize that personalized eHealth education and motivational-interviewing-based counseling will improve adherence to glaucoma follow-up care compared ...