RESEARCH PROTOCOL: Glaucoma Treatment Adherence and Persistence

Primary Open Angle Glaucoma Clinical Trial

Official title:

An Assessment of the Impact of Motivational Interviewing Via Glaucoma Educator on Glaucoma Treatment Adherence and Persistence

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01409421
• Other study ID #: 11-0122
• Secondary ID: 2517807
• Status: Completed
• Phase: N/A
• First received: August 2, 2011
• Last updated: September 30, 2015
• Start date: April 2011
• Est. completion date: January 2013

Study information

• Verified date: September 2015
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 201
• Est. completion date: January 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Caregiver), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Glaucoma
• Glaucoma, Open-Angle
• Primary Open Angle Glaucoma

Intervention

Behavioral:
• motivational interviewing
counseling intervention
• three phone calls to remind patients to take their eye drops
reminder phone calls

Locations

Country	Name	City	State
United States	Lions Eye Institute, UC Denver	Aurora	Colorado
United States	Devers Eye Institute	Portland	Oregon

Sponsors (2)

Lead Sponsor	Collaborator
University of Colorado, Denver	Merck Sharp & Dohme Corp.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No