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The eyeGuide: Improving Glaucoma Self-management With a Personalized Behavior Change Program

The eyeGuide: Improving Glaucoma Self-management With a Personalized Behavior Change Program

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03159247
Acronym
eyeGuide
Enrollment
107
Registered
2017-05-18
Start date
2017-01-12
Completion date
2020-01-10
Last updated
2024-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Glaucoma, Medication Adherence

Keywords

education, counseling, motivational interviewing, tailoring

Brief summary

The purpose of this research study is to test the impact of two personalized technology based programs that may help improve adherence to glaucoma medications.

Detailed description

Despite evidence from randomized clinical trials that medication reduces vision loss from glaucoma, it remains the second leading cause of blindness in the United States. A critical barrier to preventing vision loss is that about one-half of glaucoma patients are essentially untreated because they do not adhere to their medications. Ineffective self-management behaviors and poor clinical outcomes disproportionately affect the most vulnerable members of US society. The increased burden of glaucoma due to an aging US population, together with a projected shortage of ophthalmologists, will make team-based care essential. There is a critical need to develop and test team-based, personalized behavior change interventions for glaucoma patients to improve medication adherence and the outcomes of care. Poor adherence to effective medications is a critical barrier to better outcomes in glaucoma patients. The World Health Organization stated that increasing the effectiveness of adherence interventions may have a far greater impact on the health of the population than any improvement in specific medical treatments. Once diagnosed with glaucoma, at least half of patients do not adhere to their glaucoma medication regimen, return for follow-up, or persist with their medications over the longer term. Patients who are not adherent have more severe visual field loss, which leads to steep declines in health-related quality of life and increased risk of falls and motor vehicle accidents. Adherence to glaucoma medications is rarely addressed during the clinical encounter because education and counseling programs are not part of standard glaucoma care. Focus groups have demonstrated that patients often have a poor understanding of glaucoma and its treatment. In addition to knowledge gaps, patients have numerous concrete and psychological barriers to managing their glaucoma. In addition, eye drop instillation is rarely taught, and many patients cannot properly instill their medications. Uniform, scripted approaches to improve adherence do not work. However, complex, individualized counseling interventions, especially those based in motivational interviewing (MI), have improved adherence and health outcomes in many chronic diseases. MI is a style of counseling that engages patients by discussing priorities and obstacles to facilitate intrinsic motivation to change health behavior. Few complex interventions based on these successful principles have been rigorously tested and none implemented into glaucoma care. The eyeGuide is a web-based personally tailored behavior change program based on MI principles, a systematic review of the glaucoma adherence literature, and data from focus groups, surveys and iterative beta-testing with glaucoma patients. It provides individually tailored disease information and support to facilitate MI-based conversations between patients and paraprofessional staff to improve medication adherence. Such technology-based electronic health (eHealth) innovations have great potential to extend the reach of physicians by enabling team-based care. In this pilot study, the study will test the impact of two personalized eHealth technologies on medication adherence among non-adherent glaucoma patients in a pre-post design: 1) real time automated adherence reminders; and 2) the eyeGuide counseling program. The study will explore the effects of these interventions on secondary outcomes including psychosocial mediators of adherence (e.g. motivation, self-efficacy, satisfaction), intraocular pressure (IOP), and IOP fluctuation.

Interventions

BEHAVIORALeyeGuide

The eyeGuide, a web-based tool to facilitate a personalized behavior change program for non-adherent glaucoma patients.

Sponsors

National Eye Institute (NEI)
CollaboratorNIH
Research to Prevent Blindness
CollaboratorOTHER
Henry Ford Health System
CollaboratorOTHER
University of Michigan
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Intervention model description

This is a single group prospective behavioral intervention with a pre-post design. Adherence will be measured for three months at baseline, for an additional one month after an automated reminder system is initiated, for an additional six months during a personalized behavior change intervention and then for one year after the intervention.

Eligibility

Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Diagnosis of glaucoma, glaucoma suspect or ocular hypertension * Taking ≥ 1 glaucoma medication * Age ≥ 40 years * Non-adherent to glaucoma medications by both self-report and three months of electronic medication monitoring (adherence ≤ 80%)

Exclusion criteria

* Cognitive impairment * Severe mental illness * Do not administer own glaucoma medications * Do not speak English

Design outcomes

Primary

MeasureTime frameDescription
Electronically monitored glaucoma medication adherence22 monthselectronic medication monitoring

Secondary

MeasureTime frameDescription
Proportion of days covered with medication22 monthsmonthly pharmacy refill data for glaucoma medications
Change in self-reported medication adherence22 monthsTwo survey instruments will be used to determine the amount of change in overall adherence
Change in eye drop instillation technique4 months elapsed between 4 month and 8 month site visitseye drop instillation technique will be video taped and analyzed on the 4 month and 8 month study visits
Change in Intra-ocular Pressure22 monthsIntra-ocular pressure will be measured by Goldmann applanation tonometry
Change in Intra-ocular Pressure Fluctuation22 monthsIntraocular pressure data will be analyzed to assess a change in pressure fluctuations

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 23, 2026