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RESEARCH PROTOCOL: Glaucoma Treatment Adherence and Persistence

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01409421
Recruitment Status : Completed
First Posted : August 4, 2011
Last Update Posted : October 1, 2015
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Primary Open Angle Glaucoma Behavioral: motivational interviewing Behavioral: three phone calls to remind patients to take their eye drops Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 201 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Care Provider)
Primary Purpose: Supportive Care
Official Title: An Assessment of the Impact of Motivational Interviewing Via Glaucoma Educator on Glaucoma Treatment Adherence and Persistence
Study Start Date : April 2011
Actual Primary Completion Date : January 2013
Actual Study Completion Date : January 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma

Arm Intervention/treatment
Experimental: motivational interviewing
3 phone and 3 in person counseling support sessions with glaucoma educator
Behavioral: motivational interviewing
counseling intervention

Active Comparator: reminder calls
behavioral: three phone calls to remind patients to take their eye drops
Behavioral: three phone calls to remind patients to take their eye drops
reminder phone calls

No Intervention: standard care
standard care for glaucoma

Primary Outcome Measures :
  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 Outcome Measures :
  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)

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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).

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 identifier (NCT number): NCT01409421

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United States, Colorado
Lions Eye Institute, UC Denver
Aurora, Colorado, United States, 80045
United States, Oregon
Devers Eye Institute
Portland, Oregon, United States, 97210
Sponsors and Collaborators
University of Colorado, Denver
Merck Sharp & Dohme Corp.
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Principal Investigator: Malik Kahook, MD Lions Eye Inst. UC Denver
Principal Investigator: Paul F Cook, Ph.D UC Denver, College of Nursing
Principal Investigator: Jeffery Kammer, MD Vanderbilt University- Opthamology
Principal Investigator: Steve Mansberger, MD Devers Eye Inst. Oregon
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: University of Colorado, Denver Identifier: NCT01409421    
Other Study ID Numbers: 11-0122
2517807 ( Other Identifier )
First Posted: August 4, 2011    Key Record Dates
Last Update Posted: October 1, 2015
Last Verified: September 2015
Keywords provided by University of Colorado, Denver:
motivational interviewing
Additional relevant MeSH terms:
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Glaucoma, Open-Angle
Ocular Hypertension
Eye Diseases
Ophthalmic Solutions
Pharmaceutical Solutions