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| ID | Type | Description | Link |
|---|---|---|---|
| 2517807 | Other Identifier |
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| Name | Class |
|---|---|
| Merck Sharp & Dohme LLC | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| motivational interviewing | Experimental | 3 phone and 3 in person counseling support sessions with glaucoma educator |
|
| reminder calls | Active Comparator | behavioral: three phone calls to remind patients to take their eye drops |
|
| standard care | No Intervention | standard care for glaucoma |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| motivational interviewing | Behavioral | counseling intervention |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lions Eye Institute, UC Denver | Aurora | Colorado | 80045 | United States | ||
| Devers Eye Institute |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25248302 | Derived | 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. |
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| ID | Term |
|---|---|
| D005902 | Glaucoma, Open-Angle |
| D005901 | Glaucoma |
| ID | Term |
|---|---|
| D009798 | Ocular Hypertension |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D062405 | Motivational Interviewing |
| ID | Term |
|---|---|
| D037001 | Directive Counseling |
| D003376 | Counseling |
| D008605 | Mental Health Services |
| D004191 | Behavioral Disciplines and Activities |
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| three phone calls to remind patients to take their eye drops |
| Behavioral |
reminder phone calls |
|
| 1 Month |
| Portland |
| Oregon |
| 97210 |
| United States |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |