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OpenTrials
Completed

NCT Number: NCT01409421

RESEARCH PROTOCOL: Glaucoma Treatment Adherence and Persistence

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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Key information

Conditions

Primary Open Angle Glaucoma Eye Diseases Glaucoma Glaucoma, Open-Angle Ocular Hypertension

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Lions Eye Institute, UC Denver, Aurora, Colorado, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Motivational Interviewing

Behavioral

counseling intervention

three phone calls to remind patients to take their eye drops

Behavioral

reminder phone calls

Primary outcomes

  1. 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

  1. Counselor-Rated Medication Adherence

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Collaborators

  • Merck Sharp & Dohme LLC

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Aug 4, 2011
Registry last updated
Oct 1, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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