Dual Antiplatelet Therapy Adherence With Reminder App Usage

Montefiore Medicine Academic Health System

Status: Terminated

Conditions: Aneurysm Cerebral (Unruptured)

Treatments: Other: Endovascular Neurosurgery

Study type: Interventional

Funder types: Other

Identifiers

NCT05071027

2021-13195

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 9 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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9 participants in 2 patient groups

App Medication Reminder Group

Experimental group

Description:

Patients in this group will receive dual antiplatelet medication reminders.

Treatment:

Other: Endovascular Neurosurgery

Non-app Using Group

No Intervention group

Description:

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.