The eyeGuide: Improving Glaucoma Self-management With a Personalized Behavior Change Program (eyeGuide)
Primary Purpose
Medication Adherence, Glaucoma
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
eyeGuide
Sponsored by
About this trial
This is an interventional health services research trial for Medication Adherence focused on measuring education, counseling, motivational interviewing, tailoring
Eligibility Criteria
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
Sites / Locations
- University of Michigan
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
eyeGuide
Arm Description
Two personalized eHealth interventions aimed to improve glaucoma medication adherence.
Outcomes
Primary Outcome Measures
Electronically monitored glaucoma medication adherence
electronic medication monitoring
Secondary Outcome Measures
Proportion of days covered with medication
monthly pharmacy refill data for glaucoma medications
Change in self-reported medication adherence
Two survey instruments will be used to determine the amount of change in overall adherence
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
Change in Intra-ocular Pressure
Intra-ocular pressure will be measured by Goldmann applanation tonometry
Change in Intra-ocular Pressure Fluctuation
Intraocular pressure data will be analyzed to assess a change in pressure fluctuations
Full Information
NCT ID
NCT03159247
First Posted
May 12, 2017
Last Updated
August 14, 2020
Sponsor
University of Michigan
Collaborators
National Eye Institute (NEI), Research to Prevent Blindness, Henry Ford Health System
1. Study Identification
Unique Protocol Identification Number
NCT03159247
Brief Title
The eyeGuide: Improving Glaucoma Self-management With a Personalized Behavior Change Program
Acronym
eyeGuide
Official Title
The eyeGuide: Improving Glaucoma Self-management With a Personalized Behavior Change Program
Study Type
Interventional
2. Study Status
Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
January 12, 2017 (Actual)
Primary Completion Date
January 10, 2020 (Actual)
Study Completion Date
January 10, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan
Collaborators
National Eye Institute (NEI), Research to Prevent Blindness, Henry Ford Health System
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Medication Adherence, Glaucoma
Keywords
education, counseling, motivational interviewing, tailoring
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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.
Masking
None (Open Label)
Allocation
N/A
Enrollment
107 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
eyeGuide
Arm Type
Experimental
Arm Description
Two personalized eHealth interventions aimed to improve glaucoma medication adherence.
Intervention Type
Behavioral
Intervention Name(s)
eyeGuide
Intervention Description
The eyeGuide, a web-based tool to facilitate a personalized behavior change program for non-adherent glaucoma patients.
Primary Outcome Measure Information:
Title
Electronically monitored glaucoma medication adherence
Description
electronic medication monitoring
Time Frame
22 months
Secondary Outcome Measure Information:
Title
Proportion of days covered with medication
Description
monthly pharmacy refill data for glaucoma medications
Time Frame
22 months
Title
Change in self-reported medication adherence
Description
Two survey instruments will be used to determine the amount of change in overall adherence
Time Frame
22 months
Title
Change in eye drop instillation technique
Description
eye drop instillation technique will be video taped and analyzed on the 4 month and 8 month study visits
Time Frame
4 months elapsed between 4 month and 8 month site visits
Title
Change in Intra-ocular Pressure
Description
Intra-ocular pressure will be measured by Goldmann applanation tonometry
Time Frame
22 months
Title
Change in Intra-ocular Pressure Fluctuation
Description
Intraocular pressure data will be analyzed to assess a change in pressure fluctuations
Time Frame
22 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paula A Newman-Casey, MD, MS
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48105
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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The eyeGuide: Improving Glaucoma Self-management With a Personalized Behavior Change Program
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