Dual Antiplatelet Therapy Adherence With Reminder App Usage

Study Overview
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Brief Summary
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The purpose of this study is to evaluate Dual Antiplatelet Therapy adherence in patients undergoing stent-based endovascular treatment for unruptured cervical and intradural, intracranial aneurysms. Patients will be randomized on a 1:1 basis to either a medication reminder app group or a control group, with patients in both groups receiving the standard of care. The app in question, Endovascular Neurosurgery, is available on the app store. The app does not collect user data and has not been officially deemed HIPAA compliant. The only data inputted into the app are the patient's procedure date and the antiplatelet medications the patient has been prescribed. The app does not possess sensitive patient data. Patients will input the time notifications will be sent and the app will be available in both Spanish and English. The investigators will be assessing medication adherence via the Adherence Barriers Questionnaire.

Detailed Description
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This will be a randomized control trial, with patients undergoing stent-based endovascular treatment for unruptured cervical and intradural, intracranial aneurysms. Informed consent will be obtained from participating patients. Patients will be assigned to either the app group or the control group. The particular stent-based therapy, either flow-diverter devices [FDD] placement or stent-assisted coiling, will be chosen for each patient by the clinical team. During the study consultation, the app group will have the app installed on their smart phones and will be trained in its usage. Thromboelastography [TEG] and Aspirin inhibition percentage will be determined for each patient following the procedure. Patients with TEG less than 60% will have Dual Antiplatelet Therapy [DAPT] changed from 81 mg aspirin and 75 mg clopidogrel to 81 mg aspirin and 10 mg prasugrel. Patients with aspirin inhibition percentages of less than 20% will have their aspirin doses increased to 325 mg. Medication compliance of all participants will be assessed on the day of the procedure via a medication compliance questionnaire. The same questionnaire will be administered during follow-up appointments 2-4 weeks and 6 months post-procedure.

Official Title
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Dual Antiplatelet Therapy Adherence With Reminder App Usage

Conditions
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Aneurysm Cerebral (Unruptured)

Intervention / Treatment
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* Other: Endovascular Neurosurgery


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years of age or older Must speak either English or Spanish fluently Physically able to come to the research site location. Elective stent-based procedures for unruptured cervical, and intracranial, intradural aneurysms Endovascular therapy must be deemed appropriate by clinical team. Exclusion Criteria: Presence of aneurysm where treatment plan does not include dual anti-platelet therapy Presence of comorbidities that preclude the possibility of treatment. Presence of contraindications to Dual Antiplatelet Therapy. Presence of certain vessel anatomical characteristics. Lack of iphone.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: App Medication Reminder Group<br>Patients in this group will receive dual antiplatelet medication reminders. | Other: Endovascular Neurosurgery<br>* Custom Dual Antiplatelet Therapy reminders for patients receiving endovascular treatment of cerebral unruptured aneurysms. The app utilized to generate reminders is available on the Apple app store.<br>|
| No Intervention: Non-app Using Group<br>Patients in this group receive the same standard of care [i.e. endovascular stent-based treatment of unruptured aneurysms] as the other group, but do not receive app dual antiplatelet reminders. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Medication Adherence | Change in baseline medication adherence, from the day of the procedure to ultimately 6 months post-procedure, as assessed by a medication compliance score generated by the Adherence Barrier Questionnaire. This score ranges from 14 to 52 and a higher score indicates that a patient faces greater barriers to medication adherence. | Day of Procedure, 2-4 weeks post-procedure, 6 months post-procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dual Antiplatelet Therapy Non-adherence associated mortality | Patient Death | 6 months post-procedure | 
| Dual Antiplatelet Therapy Non-adherence associated morbidity | Incidence of stroke/thrombotic events, all-cause morbidity, rehospitalization for cerebrovascular events, peri-treatment hospitalization lasting more than 15 days, and delayed discharge from hospital. | 6 months post-procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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aneurysm, unruptured, antiplatelet, adherence, reminder, medication, DAPT