Dual Antiplatelet Therapy Adherence With Reminder App Usage

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.

Study Overview

• Status: Terminated
• Conditions: Aneurysm Cerebral (Unruptured)
• Intervention / Treatment: Other: Endovascular Neurosurgery

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.

• Study Type: Interventional
• Enrollment (Actual): 9
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10467
      • Montefiore Medical Center Department of Neurosurgery

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: App Medication Reminder Group; Patients in this group will receive dual antiplatelet medication reminders.	Other: 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.
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Montefiore Medical Center
• Investigators: Principal Investigator: David Altschul, MD, Associate Professor in The Leo M. Davidoff Department of Neurological Surgery at Montefiore

Study record dates

Study Major Dates

• Study Start (Actual): October 27, 2021
• Primary Completion (Actual): July 22, 2024
• Study Completion (Actual): July 22, 2024

Study Registration Dates

• First Submitted: September 23, 2021
• First Submitted That Met QC Criteria: October 6, 2021
• First Posted (Actual): October 7, 2021

Study Record Updates

• Last Update Posted (Actual): November 15, 2024
• Last Update Submitted That Met QC Criteria: September 5, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: adherence; medication; aneurysm; antiplatelet; unruptured; reminder; DAPT
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Aneurysm
• Other Study ID Numbers: 2021-13195

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: All collected Individual Participant Data [IPD].
• IPD Sharing Time Frame: The data will be available upon completion of the study, subsequent publication, and at least 3 years afterward.
• IPD Sharing Access Criteria: Information will be shared with all auditors including FDA, ethics committees, and review boards. Requests will be reviewed by the study's investigators.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No