RESEARCH PROTOCOL: Glaucoma Treatment Adherence and Persistence

An Assessment of the Impact of Motivational Interviewing Via Glaucoma Educator on 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.

Study Overview

• Status: Completed
• Conditions: Primary Open Angle Glaucoma
• Intervention / Treatment: Behavioral: motivational interviewing; Behavioral: three phone calls to remind patients to take their eye drops

• Study Type: Interventional
• Enrollment (Actual): 201
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Lions Eye Institute, UC Denver
  • Oregon
    • Portland, Oregon, United States, 97210
      • Devers Eye Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary Outcomes - MEMS-based Medication Adherence and Persistence:	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.	1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Counselor-Rated Medication Adherence	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)	1 Month

Collaborators and Investigators

• Sponsor: University of Colorado, Denver
• Collaborators: Merck Sharp & Dohme LLC
• Investigators: 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 and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: April 1, 2011
• Primary Completion (Actual): January 1, 2013
• Study Completion (Actual): January 1, 2013

Study Registration Dates

• First Submitted: August 2, 2011
• First Submitted That Met QC Criteria: August 3, 2011
• First Posted (Estimate): August 4, 2011

Study Record Updates

• Last Update Posted (Estimate): October 1, 2015
• Last Update Submitted That Met QC Criteria: September 30, 2015
• Last Verified: September 1, 2015

More Information

Terms related to this study

• Keywords: adherence; motivational interviewing; glaucoma
• Additional Relevant MeSH Terms: Eye Diseases; Ocular Hypertension; Glaucoma; Glaucoma, Open-Angle; Pharmaceutical Solutions; Ophthalmic Solutions
• Other Study ID Numbers: 11-0122; 2517807 (Other Identifier)