RESEARCH PROTOCOL: Glaucoma Treatment Adherence and Persistence

This study has been completed.
Sponsor:
Collaborator:
Merck
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

August 2, 2011
January 15, 2013
April 2011
January 2013   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01409421 on ClinicalTrials.gov Archive Site
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)
Same as current
Not Provided
Not Provided
 
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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Caregiver)
Primary Purpose: Supportive Care
Primary Open Angle Glaucoma
  • Behavioral: motivational interviewing
    counseling intervention
  • Behavioral: three phone calls to remind patients to take their eye drops
    reminder phone calls
  • Experimental: motivational interviewing
    3 phone and 3 in person counseling support sessions with glaucoma educator
    Intervention: Behavioral: motivational interviewing
  • Active Comparator: reminder calls
    behavioral: three phone calls to remind patients to take their eye drops
    Intervention: Behavioral: three phone calls to remind patients to take their eye drops
  • No Intervention: standard care
    standard care for glaucoma
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
201
January 2013
January 2013   (final data collection date for primary outcome measure)

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).
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01409421
11-0122, 2517807
Yes
University of Colorado, Denver
University of Colorado, Denver
Merck
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
University of Colorado, Denver
September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP