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

Not Applicable

Completed

• Conditions: Medication Adherence; Glaucoma
• Interventions: Behavioral: eyeGuide

• Registration Number: NCT03159247
• Lead Sponsor: University of Michigan

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.

Study Timeline

• Study Start: 2017-01-12
• Study First Submitted: 2017-05-12
• Study First Submitted QC: 2017-05-16
• Study First Posted: 2017-05-18
• Primary Completion: 2020-01-10
• Study Completion: 2020-01-10
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-15
• Last Update Posted: 2024-03-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 107

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%)

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
eyeGuide	eyeGuide	Two personalized eHealth interventions aimed to improve glaucoma medication adherence.

Primary Outcome Measures

Name	Time	Method
Electronically monitored glaucoma medication adherence	22 months	electronic medication monitoring

Secondary Outcome Measures

Name	Time	Method
Change in self-reported medication adherence	22 months	Two survey instruments will be used to determine the amount of change in overall adherence
Change in Intra-ocular Pressure Fluctuation	22 months	Intraocular pressure data will be analyzed to assess a change in pressure fluctuations
Proportion of days covered with medication	22 months	monthly pharmacy refill data for glaucoma medications
Change in eye drop instillation technique	4 months elapsed between 4 month and 8 month site visits	eye drop instillation technique will be video taped and analyzed on the 4 month and 8 month study visits
Change in Intra-ocular Pressure	22 months	Intra-ocular pressure will be measured by Goldmann applanation tonometry

Trial Locations

Locations (1)

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States