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

Glaucoma Clinical Trial

— eyeGuide  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03159247
• Other study ID #: HUM00112614
• Secondary ID: 1K23EY025320-01A
• Status: Completed
• Phase: N/A
• Start date: January 12, 2017
• Est. completion date: January 10, 2020

Study information

• Verified date: March 2024
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 107
• Est. completion date: January 10, 2020
• Est. primary completion date: January 10, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Glaucoma
• Medication Adherence

Intervention

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

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan

Sponsors (4)

Lead Sponsor	Collaborator
University of Michigan	Henry Ford Health System, National Eye Institute (NEI), Research to Prevent Blindness

Country where clinical trial is conducted

United States, 

References & Publications (35)

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* Note: There are 35 references in all — Click here to view all references

Outcome

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