Clinical trial NCT01409421: RESEARCH PROTOCOL: Glaucoma Treatment Adherence and Persistence
Official title: An Assessment of the Impact of Motivational Interviewing Via Glaucoma Educator on Glaucoma Treatment Adherence and Persistence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Primary Open Angle Glaucoma
Keywords: adherence
glaucoma
motivational interviewing
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2011-08-04
Enrollment: 201
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


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).

Primary outcomes:
measure: Primary Outcomes - MEMS-based Medication Adherence and Persistence:
timeFrame: 1 month
Secondary outcomes:
measure: Counselor-Rated Medication Adherence
timeFrame: 1 Month
Other outcomes:
Locations:
city: Aurora
country: United States
facility: Lions Eye Institute, UC Denver
state: Colorado
city: Portland
country: United States
facility: Devers Eye Institute
state: Oregon
Study officials:
affiliation: Lions Eye Inst. UC Denver
name: Malik Kahook, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: UC Denver, College of Nursing
name: Paul F Cook, Ph.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Vanderbilt University- Opthamology
name: Jeffery Kammer, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Devers Eye Inst. Oregon
name: Steve Mansberger, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cook PF, Schmiege SJ, Mansberger SL, Kammer J, Fitzgerald T, Kahook MY. Predictors of adherence to glaucoma treatment in a multisite study. Ann Behav Med. 2015 Feb;49(1):29-39. doi: 10.1007/s12160-014-9641-8.