RESEARCH PROTOCOL: Glaucoma Treatment Adherence and Persistence

This study has been completed.
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
University of Colorado, Denver
ClinicalTrials.gov Identifier:
NCT01409421
First received: August 2, 2011
Last updated: January 15, 2013
Last verified: September 2012
  Purpose

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 Intervention
Primary Open Angle Glaucoma
Behavioral: motivational interviewing
Behavioral: three phone calls to remind patients to take their eye drops

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Caregiver)
Primary Purpose: Supportive Care
Official Title: An Assessment of the Impact of Motivational Interviewing Via Glaucoma Educator on Glaucoma Treatment Adherence and Persistence

Resource links provided by NLM:


Further study details as provided by University of Colorado, Denver:

Primary Outcome Measures:
  • Primary Outcomes - MEMS-based Medication Adherence and Persistence: [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    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:
  • Counselor-Rated Medication Adherence [ Time Frame: 1 Month ] [ Designated as safety issue: No ]
    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)


Enrollment: 201
Study Start Date: April 2011
Study Completion Date: January 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01409421

Locations
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.
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
  More Information

No publications provided

Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT01409421     History of Changes
Other Study ID Numbers: 11-0122, 2517807
Study First Received: August 2, 2011
Last Updated: January 15, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Colorado, Denver:
adherence
glaucoma
motivational interviewing

Additional relevant MeSH terms:
Glaucoma
Glaucoma, Open-Angle
Ocular Hypertension
Eye Diseases

ClinicalTrials.gov processed this record on September 16, 2014