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

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ClinicalTrials.gov Identifier: NCT03159247
Recruitment Status : Active, not recruiting
First Posted : May 18, 2017
Last Update Posted : October 24, 2018
Sponsor:
Collaborators:
National Eye Institute (NEI)
Research to Prevent Blindness
Henry Ford Health System
Information provided by (Responsible Party):
Paula Anne Newman-Casey, 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.

Condition or disease Intervention/treatment Phase
Medication Adherence Glaucoma Behavioral: eyeGuide Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 107 participants
Intervention Model: Single Group Assignment
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.
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: The eyeGuide: Improving Glaucoma Self-management With a Personalized Behavior Change Program
Actual Study Start Date : January 12, 2017
Estimated Primary Completion Date : October 12, 2020
Estimated Study Completion Date : October 12, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma

Arm Intervention/treatment
Experimental: eyeGuide
Two personalized eHealth interventions aimed to improve glaucoma medication adherence.
Behavioral: eyeGuide
The eyeGuide, a web-based tool to facilitate a personalized behavior change program for non-adherent glaucoma patients.




Primary Outcome Measures :
  1. Electronically monitored glaucoma medication adherence [ Time Frame: 22 months ]
    electronic medication monitoring


Secondary Outcome Measures :
  1. Proportion of days covered with medication [ Time Frame: 22 months ]
    monthly pharmacy refill data for glaucoma medications

  2. Change in self-reported medication adherence [ Time Frame: 22 months ]
    Two survey instruments will be used to determine the amount of change in overall adherence

  3. Change in eye drop instillation technique [ Time Frame: 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

  4. Change in Intra-ocular Pressure [ Time Frame: 22 months ]
    Intra-ocular pressure will be measured by Goldmann applanation tonometry

  5. Change in Intra-ocular Pressure Fluctuation [ Time Frame: 22 months ]
    Intraocular pressure data will be analyzed to assess a change in pressure fluctuations



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03159247


Locations
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United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48105
Sponsors and Collaborators
University of Michigan
National Eye Institute (NEI)
Research to Prevent Blindness
Henry Ford Health System
Investigators
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Principal Investigator: Paula A Newman-Casey, MD, MS University of Michigan

Publications:
Sabate E. Adherence to Long-Term Therapies: Evidence for Action. Geneva, Switzerland: World Health Organization (WHO); 2003. Available at: http://www.who.int/chp/knowledge/publications/adherence_full_report.pdf. Accessed June 7, 2015.
Miller WR and Rollnick S. Motivational Interviewing: Helping people change, 3rd edition. 2013; Guilford Press, New York, NY.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Paula Anne Newman-Casey, Assistant Professor of Ophthalmology and Visual Sciences, University of Michigan
ClinicalTrials.gov Identifier: NCT03159247     History of Changes
Other Study ID Numbers: HUM00112614
1K23EY025320-01A1 ( U.S. NIH Grant/Contract )
First Posted: May 18, 2017    Key Record Dates
Last Update Posted: October 24, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Paula Anne Newman-Casey, University of Michigan:
education
counseling
motivational interviewing
tailoring

Additional relevant MeSH terms:
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Glaucoma
Ocular Hypertension
Eye Diseases