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Clinical Trials/NCT01409421
NCT01409421
Completed
Not Applicable

An Assessment of the Impact of Motivational Interviewing Via Glaucoma Educator on Glaucoma Treatment Adherence and Persistence

University of Colorado, Denver2 sites in 1 country201 target enrollmentApril 2011

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Primary Open Angle Glaucoma
Sponsor
University of Colorado, Denver
Enrollment
201
Locations
2
Primary Endpoint
Primary Outcomes - MEMS-based Medication Adherence and Persistence:
Status
Completed
Last Updated
10 years ago

Overview

Brief Summary

The investigators are studying motivational interviewing (MI). MI is a counseling method to help people adopt healthy behaviors. The investigators will test whether MI improves patients' accurate use of glaucoma eye drops. The investigators will train eye clinic staff called glaucoma educators to use MI. Up to 250 patients at 3 clinics will be recruited. All patients will receive their usual eye care. Based on chance, some patients will also be supported by a glaucoma educator. The groups will be compared on medication adherence using micro-electro-mechanical system(MEMS). MEMS are electronic bottle caps that track when a medication bottle is opened. Patients will be aware that their medication use is tracked. The groups will also be compared on treatment value, outcomes, and cost. The investigators will also collect data on variables that may predict medication adherence.

Registry
clinicaltrials.gov
Start Date
April 2011
End Date
January 2013
Last Updated
10 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • community-dwelling adults with primary or secondary open-angle glaucoma, and
  • a current prescription for monotherapy topical glaucoma medication.

Exclusion Criteria

  • patient-reported inability to administer eye drops that cannot be addressed successfully through in-person instruction at the clinic,
  • cognitive impairment at a level that would in the judgment of the referring physician interfere with study participation,
  • referring physician's determination that glaucoma surgery is likely within the next 6 months,
  • any active medical, psychological, or substance use disorder that would in the referring physician's judgment significantly interfere with study participation (e.g., comorbid congestive heart failure (CHF) resulting in a recent hospitalization; active psychosis due to uncontrolled bipolar disorder; etc.), or
  • no visual field test within the past 6 months (data required for the randomization approach described below).

Outcomes

Primary Outcomes

Primary Outcomes - MEMS-based Medication Adherence and Persistence:

Time Frame: 1 month

Compare adherence and persistence between the intervention and control groups. (Medication Event Monitoring Systems)that record the date and time a pill bottle is opened we are evaluating the percentage of prescribed doses taken during ain one-week intervals, but will augment it by also considering a more fine-grained percentage of prescribed doses taken in required dosing window (defined as within 3 hours before or after the scheduled time) as a second primary outcome measure.

Secondary Outcomes

  • Counselor-Rated Medication Adherence(1 Month)

Study Sites (2)

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