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The PI is discontinuing the study since the platform/Application is no longer available for use. Study terminated effective 7/29/2024.
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| App Medication Reminder Group | Experimental | Patients in this group will receive dual antiplatelet medication reminders. |
|
| Non-app Using Group | No Intervention | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Endovascular Neurosurgery | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Day of Procedure, 2-4 weeks post-procedure, 6 months post-procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Dual Antiplatelet Therapy Non-adherence Associated Mortality | Mortality data associated with non-adherence to Dual Antiplatelet Therapy is summarized by study arm/group. | Up to 6 months post-procedure |
| Dual Antiplatelet Therapy Non-adherence Associated Morbidity and Related Adverse Events |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Altschul, MD | Associate Professor in The Leo M. Davidoff Department of Neurological Surgery at Montefiore | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Montefiore Medical Center Department of Neurosurgery | New York | New York | 10467 | United States |
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1 patient died prior to being administered the application. They were randomized into the "App Medication Reminder Group" but never received the application.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
The remaining of the patients did not complete the follow up.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Day of Procedure, 2-4 weeks post-procedure, 6 months post-procedure |
|
6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. David Altschul, Department of Neurosurgery | Montefiore Medical Center | 718-920-7498 | daltschu@montefiore.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 27, 2021 | Sep 5, 2024 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Sep 8, 2023 | Sep 5, 2024 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D002532 | Intracranial Aneurysm |
| D000783 | Aneurysm |
| ID | Term |
|---|---|
| D020765 | Intracranial Arterial Diseases |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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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. |
| Up to 6 months post-procedure |
| 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | 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. |
|
| Secondary | Dual Antiplatelet Therapy Non-adherence Associated Mortality | Mortality data associated with non-adherence to Dual Antiplatelet Therapy is summarized by study arm/group. | 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. | Posted | Count of Participants | Participants | Up to 6 months post-procedure |
|
|
|
| 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. | 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. | Posted | Count of Participants | Participants | Up to 6 months post-procedure |
|
|
|
| 0 |
| 3 |
| 0 |
| 3 |
| 0 |
| 3 |
| EG001 | 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. | 0 | 6 | 0 | 6 | 0 | 6 |
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| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |