Aneurysm Cerebral (Unruptured)
Conditions
Keywords
aneurysm, unruptured, antiplatelet, adherence, reminder, medication, DAPT
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.
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.
Interventions
OTHEREndovascular Neurosurgery
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.
Sponsors
Montefiore Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Medication Adherence | Day of Procedure, 2-4 weeks post-procedure, 6 months post-procedure | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Dual Antiplatelet Therapy Non-adherence Associated Mortality | Up to 6 months post-procedure | Mortality data associated with non-adherence to Dual Antiplatelet Therapy is summarized by study arm/group. |
| Dual Antiplatelet Therapy Non-adherence Associated Morbidity and Related Adverse Events | Up to 6 months post-procedure | 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. |
Countries
United States
Participant flow
Pre-assignment details
1 patient died prior to being administered the application. They were randomized into the App Medication Reminder Group but never received the application.
Participants by arm
| Arm | Count |
|---|---|
| App Medication Reminder Group Patients in this group will receive dual antiplatelet medication reminders.
Endovascular Neurosurgery: 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. | 3 |
| Non-app Using Group 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. | 6 |
| Total | 9 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 4 |
Baseline characteristics
| Characteristic | Total | Non-app Using Group | App Medication Reminder Group |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 2 Participants | 1 Participants | 1 Participants |
| Age, Categorical Between 18 and 65 years | 7 Participants | 5 Participants | 2 Participants |
| Race/Ethnicity, Customized Black or African-American | 3 Participants | 1 Participants | 2 Participants |
| Race/Ethnicity, Customized Other, Not Spanish/Hispanic/Latino | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Spanish/Hispanic/Latino | 4 Participants | 4 Participants | 0 Participants |
| Race/Ethnicity, Customized White, Spanish/Hispanic/Latino | 1 Participants | 1 Participants | 0 Participants |
| Region of Enrollment United States | 9 participants | 6 participants | 3 participants |
| Sex: Female, Male Female | 9 Participants | 6 Participants | 3 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 3 | 0 / 6 |
| other Total, other adverse events | 0 / 3 | 0 / 6 |
| serious Total, serious adverse events | 0 / 3 | 0 / 6 |
Outcome results
Primary
Change in Medication Adherence
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.
Time frame: Day of Procedure, 2-4 weeks post-procedure, 6 months post-procedure
Population: Data related to 'Change in Medication Adherence' was unable to be collected in order to obtain an Adherence Barrier Questionnaire Score and, as such, this Outcome was unable to be evaluated.
Secondary
Dual Antiplatelet Therapy Non-adherence Associated Morbidity and Related Adverse Events
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.
Time frame: Up to 6 months post-procedure
Population: Two participants in each arm/group were able to be evaluated for Dual Antiplatelet Therapy Non-adherence associated mortalities. Other participants were lost to follow up.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| App Medication Reminder Group | Dual Antiplatelet Therapy Non-adherence Associated Morbidity and Related Adverse Events | 0 Participants |
| Non-app Using Group | Dual Antiplatelet Therapy Non-adherence Associated Morbidity and Related Adverse Events | 0 Participants |
Secondary
Dual Antiplatelet Therapy Non-adherence Associated Mortality
Mortality data associated with non-adherence to Dual Antiplatelet Therapy is summarized by study arm/group.
Time frame: Up to 6 months post-procedure
Population: Two participants in each arm/group were able to be evaluated for Dual Antiplatelet Therapy Non-adherence associated mortalities. Other participants were lost to follow up.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| App Medication Reminder Group | Dual Antiplatelet Therapy Non-adherence Associated Mortality | 0 Participants |
| Non-app Using Group | Dual Antiplatelet Therapy Non-adherence Associated Mortality | 0 Participants |