RESEARCH PROTOCOL: Glaucoma Treatment Adherence and Persistence

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

201 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-04-30

Study Completion Date

2013-01-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Primary Open Angle Glaucoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Caregivers

Study Groups

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motivational interviewing

3 phone and 3 in person counseling support sessions with glaucoma educator

Group Type EXPERIMENTAL

motivational interviewing

Intervention Type BEHAVIORAL

counseling intervention

reminder calls

behavioral: three phone calls to remind patients to take their eye drops

Group Type ACTIVE_COMPARATOR

three phone calls to remind patients to take their eye drops

Intervention Type BEHAVIORAL

reminder phone calls

standard care

standard care for glaucoma

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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motivational interviewing

counseling intervention

Intervention Type BEHAVIORAL

three phone calls to remind patients to take their eye drops

reminder phone calls

Intervention Type BEHAVIORAL

Eligibility Criteria

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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).

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes