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Lack of sufficient recruitment
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| Name | Class |
|---|---|
| Kali Care | UNKNOWN |
| Barney's Pharmacy | UNKNOWN |
| Creative Care Pharmacy | UNKNOWN |
| Hutton Pharmacy |
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This study will evaluate the effectiveness of real-time data collected on patients taking topical medication to treat glaucoma. Patients will be randomized to two groups, the first of which will only use the study device to take their medication, while the second will use the study device and receive on-demand reminder messages, when necessary.
Adherence to topical medications to treat glaucoma remains sub optimal; however, our understanding of this behavior remains limited due to biased measures of medication use. The Kali Drop device is a potential improvement in our ability to capture medication use in patients using dropper bottles by precisely capturing the amount dispensed in real-time. Moreover, such technology creates data that can be leveraged into driving behavior change using connected mobile technology in order to improve adherence and, ultimately, health outcomes. While evidence suggests that reminders may improve adherence to glaucoma medications, the power of doing so using real-time data has yet to be explored. This study will compare simple monitoring of patients to those who are being monitored and who receive reminder messages when the system determines one is necessary due to a missed dose.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Monitoring only | Active Comparator | Patients in this arm will be given a real-time medication use monitor to use in dispensing their topical glaucoma medication for 3 months |
|
| Monitoring and reminder | Experimental | Patients in this arm will be given a real-time medication use monitor to use in dispensing their topical glaucoma medication for 3 months and will receive an automated reminder (text or voice) when a missed dose is determined by the device's system |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Medication reminder | Behavioral | Using the real-time data capture of the electronic device, an automated voice call or text message will be sent to active arm participants only when a missed dose is determined |
| Measure | Description | Time Frame |
|---|---|---|
| Adherence | Changes and differences in adherence to glaucoma medication between groups | From study baseline through the 3 months of the intervention |
| Adherence follow-up | Changes and differences in adherence to glaucoma medication between groups after the intervention | From study endpoint through the subsequent 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Medication self-efficacy using the 10-item Glaucoma Medication Adherence Self-Efficacy Scale | Differences in self-reported medication-related self-efficacy between groups | Change from baseline over the 3-month intervention |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Justin Gatwood, PhD | University of Tennessee | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Barney's Pharmacy | Augusta | Georgia | 30906 | United States | ||
| Barney's Pharmacy |
No IPD
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| ID | Term |
|---|---|
| D005901 | Glaucoma |
| ID | Term |
|---|---|
| D009798 | Ocular Hypertension |
| D005128 | Eye Diseases |
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| UNKNOWN |
| Mustang Drug | UNKNOWN |
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| Medication monitoring only | Behavioral | Patients will use an electronic medication monitoring device to record their actual medication use |
|
| Augusta |
| Georgia |
| 30907 |
| United States |
| Barney's Pharmacy | Grovetown | Georgia | 30813 | United States |
| Barney's Pharmacy | Louisville | Georgia | 30434 | United States |
| Hutton Pharmacy | Blackwell | Oklahoma | 74631 | United States |
| Creative Care Pharmacy | Edmond | Oklahoma | 73013 | United States |
| Mustang Drug | Mustang | Oklahoma | 73064 | United States |
| University of Tennessee College of Pharmacy | Nashville | Tennessee | 37210 | United States |