RESEARCH PROTOCOL: Glaucoma Treatment Adherence and Persistence

NCT01409421 | Completed DMC

• 2 other identifiers: 11-01222517807
• Study Type: interventional
• Target: 201
• Locations: 1 country
• Sites: 2

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.

Conditions

Primary Open Angle Glaucoma

Keywords

adherence; glaucoma; motivational interviewing

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Counselor-Rated Medication Adherence

  1 Month

Study Arms (3)

motivational interviewing

EXPERIMENTAL

3 phone and 3 in person counseling support sessions with glaucoma educator

Behavioral: motivational interviewing

reminder calls

ACTIVE COMPARATOR

behavioral: three phone calls to remind patients to take their eye drops

Behavioral: three phone calls to remind patients to take their eye drops

standard care

NO INTERVENTION

standard care for glaucoma

Interventions

motivational interviewing BEHAVIORAL

counseling intervention

motivational interviewing

three phone calls to remind patients to take their eye drops BEHAVIORAL

reminder phone calls

reminder calls

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• community-dwelling adults with primary or secondary open-angle glaucoma, and
• a current prescription for monotherapy topical glaucoma medication.

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of Colorado, Denver: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (2)

Lions Eye Institute, UC Denver

Aurora, Colorado, 80045, United States

Location

Devers Eye Institute

Portland, Oregon, 97210, United States

Location

Related Publications (1)

• 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.

  PMID: 25248302 DERIVED

MeSH Terms

Conditions

Glaucoma, Open-Angle; Glaucoma

Interventions

Motivational Interviewing

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases

Intervention Hierarchy (Ancestors)

Directive Counseling; Counseling; Mental Health Services; Behavioral Disciplines and Activities; Health Services; Health Care Facilities Workforce and Services

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 2, 2011
• First Posted: August 4, 2011
• Study Start: April 1, 2011
• Primary Completion: January 1, 2013
• Study Completion: January 1, 2013
• Last Updated: October 1, 2015

Record last verified: 2015-09

Locations

US (2)