RESEARCH PROTOCOL: Glaucoma Treatment Adherence and Persistence

Not Applicable

Completed

• Conditions: Primary Open Angle Glaucoma
• Interventions: Behavioral: motivational interviewing; Behavioral: three phone calls to remind patients to take their eye drops

• Registration Number: NCT01409421
• Lead Sponsor: University of Colorado, Denver

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-04
• Study First Submitted: 2011-08-02
• Study First Submitted QC: 2011-08-03
• Study First Posted: 2011-08-04
• Primary Completion: 2013-01
• Study Completion: 2013-01
• Status Verified: 2015-09
• Last Update Submitted: 2015-09-30
• Last Update Posted: 2015-10-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 201

Inclusion Criteria

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

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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).

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
motivational interviewing	motivational interviewing	3 phone and 3 in person counseling support sessions with glaucoma educator
reminder calls	three phone calls to remind patients to take their eye drops	behavioral: three phone calls to remind patients to take their eye drops

Primary Outcome Measures

Name	Time	Method
Primary Outcomes - MEMS-based Medication Adherence and Persistence:	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 Outcome Measures

Name	Time	Method
Counselor-Rated Medication Adherence	1 Month	we will supplement MEMS-based adherence metrics with a counselor rating of adherence completed by the glaucoma educator during each in-person or telephone contact with intervention group participants. The interview also measures patients' perceived reasons for nonadherence, including treatment cost, lack of commitment based on low perceived benefits of treatment, and fear of potential adverse drug events (ADEs)

Trial Locations

Locations (2)

Lions Eye Institute, UC Denver; 🇺🇸 Aurora, Colorado, United States

Devers Eye Institute; 🇺🇸 Portland, Oregon, United States