Brief Summary
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.
Brief Title
Dual Antiplatelet Therapy Adherence With Reminder App Usage
Detailed 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.
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.
Completion Date
Completion Date Type
Actual
Conditions
Aneurysm Cerebral (Unruptured)
Eligibility Criteria
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.
* 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.
Inclusion Criteria
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.
* 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.
Gender
All
Gender Based
false
Keywords
aneurysm
unruptured
antiplatelet
adherence
reminder
medication
DAPT
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT05071027
Org Class
Other
Org Full Name
Montefiore Medical Center
Org Study Id
2021-13195
Overall Status
Terminated
Phases
Not Applicable
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
Dual Antiplatelet Therapy Adherence With Reminder App Usage
Primary Outcomes
Outcome Description
Change in 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.
Outcome Measure
Change in Medication Adherence
Outcome Time Frame
Day of Procedure, 2-4 weeks post-procedure, 6 months post-procedure
Secondary Outcomes
Outcome Description
Mortality data associated with non-adherence to Dual Antiplatelet Therapy is summarized by study arm/group.
Outcome Time Frame
Up to 6 months post-procedure
Outcome Measure
Dual Antiplatelet Therapy Non-adherence Associated Mortality
Outcome Description
Instances of stroke/thrombotic events, all-cause morbidity, rehospitalization for cerebrovascular events, peri-treatment hospitalization lasting more than 15 days, and delayed discharge from hospital related to non-adherence to Dual Antiplatelet Therapy, were summarized by study arm/group.
Outcome Time Frame
Up to 6 months post-procedure
Outcome Measure
Dual Antiplatelet Therapy Non-adherence Associated Morbidity and Related Adverse Events
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
David Altschul
Investigator Email
daltschu@montefiore.org
Investigator Phone
718-920-7498