Back to resultsRESEARCH PROTOCOL: Glaucoma Treatment Adherence and Persistence
Primary Purpose
Primary Open Angle Glaucoma
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
motivational interviewing
three phone calls to remind patients to take their eye drops
Sponsored by
About this trial
This is an interventional supportive care trial for Primary Open Angle Glaucoma focused on measuring adherence, glaucoma, motivational interviewing
Eligibility 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).
Sites / Locations
- Lions Eye Institute, UC Denver
- Devers Eye Institute
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
No Intervention
Arm Label
motivational interviewing
reminder calls
standard care
Arm Description
3 phone and 3 in person counseling support sessions with glaucoma educator
behavioral: three phone calls to remind patients to take their eye drops
standard care for glaucoma
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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)
Full Information
NCT ID
NCT01409421
First Posted
August 2, 2011
Last Updated
September 30, 2015
Sponsor
University of Colorado, Denver
Collaborators
Merck Sharp & Dohme LLC
1. Study Identification
Unique Protocol Identification Number
NCT01409421
Brief Title
RESEARCH PROTOCOL: Glaucoma Treatment Adherence and Persistence
Official Title
An Assessment of the Impact of Motivational Interviewing Via Glaucoma Educator on Glaucoma Treatment Adherence and Persistence
Study Type
Interventional
2. Study Status
Record Verification Date
September 2015
Overall Recruitment Status
Completed
Study Start Date
April 2011 (undefined)
Primary Completion Date
January 2013 (Actual)
Study Completion Date
January 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Colorado, Denver
Collaborators
Merck Sharp & Dohme LLC
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Open Angle Glaucoma
Keywords
adherence, glaucoma, motivational interviewing
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care Provider
Allocation
Randomized
Enrollment
201 (Actual)
8. Arms, Groups, and Interventions
Arm Title
motivational interviewing
Arm Type
Experimental
Arm Description
3 phone and 3 in person counseling support sessions with glaucoma educator
Arm Title
reminder calls
Arm Type
Active Comparator
Arm Description
behavioral: three phone calls to remind patients to take their eye drops
Arm Title
standard care
Arm Type
No Intervention
Arm Description
standard care for glaucoma
Intervention Type
Behavioral
Intervention Name(s)
motivational interviewing
Intervention Description
counseling intervention
Intervention Type
Behavioral
Intervention Name(s)
three phone calls to remind patients to take their eye drops
Intervention Description
reminder phone calls
Primary Outcome Measure Information:
Title
Primary Outcomes - MEMS-based Medication Adherence and Persistence:
Description
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.
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Counselor-Rated Medication Adherence
Description
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)
Time Frame
1 Month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Malik Kahook, MD
Organizational Affiliation
Lions Eye Inst. UC Denver
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Paul F Cook, Ph.D
Organizational Affiliation
UC Denver, College of Nursing
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jeffery Kammer, MD
Organizational Affiliation
Vanderbilt University- Opthamology
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Steve Mansberger, MD
Organizational Affiliation
Devers Eye Inst. Oregon
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lions Eye Institute, UC Denver
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Devers Eye Institute
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
25248302
Citation
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.
Results Reference
derived
Learn more about this trial
RESEARCH PROTOCOL: Glaucoma Treatment Adherence and Persistence
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