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Dual Antiplatelet Therapy Adherence With Reminder App Usage

Primary Purpose

Aneurysm Cerebral (Unruptured)

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Endovascular Neurosurgery
Sponsored by
Montefiore Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Aneurysm Cerebral (Unruptured) focused on measuring aneurysm, unruptured, antiplatelet, adherence, reminder, medication, DAPT

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Montefiore Medical Center Department of NeurosurgeryRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

App Medication Reminder Group

Non-app Using Group

Arm Description

Patients in this group will receive dual antiplatelet medication reminders.

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.

Outcomes

Primary Outcome Measures

Medication Adherence
Change in baseline 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 Outcome Measures

Dual Antiplatelet Therapy Non-adherence associated mortality
Patient Death
Dual Antiplatelet Therapy Non-adherence associated morbidity
Incidence of stroke/thrombotic events, all-cause morbidity, rehospitalization for cerebrovascular events, peri-treatment hospitalization lasting more than 15 days, and delayed discharge from hospital.

Full Information

First Posted
September 23, 2021
Last Updated
August 23, 2023
Sponsor
Montefiore Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT05071027
Brief Title
Dual Antiplatelet Therapy Adherence With Reminder App Usage
Official Title
Dual Antiplatelet Therapy Adherence With Reminder App Usage
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 27, 2021 (Actual)
Primary Completion Date
December 2030 (Anticipated)
Study Completion Date
December 2030 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Montefiore Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aneurysm Cerebral (Unruptured)
Keywords
aneurysm, unruptured, antiplatelet, adherence, reminder, medication, DAPT

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
68 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
App Medication Reminder Group
Arm Type
Experimental
Arm Description
Patients in this group will receive dual antiplatelet medication reminders.
Arm Title
Non-app Using Group
Arm Type
No Intervention
Arm 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.
Intervention Type
Other
Intervention Name(s)
Endovascular Neurosurgery
Intervention Description
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.
Primary Outcome Measure Information:
Title
Medication Adherence
Description
Change in baseline 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
Secondary Outcome Measure Information:
Title
Dual Antiplatelet Therapy Non-adherence associated mortality
Description
Patient Death
Time Frame
6 months post-procedure
Title
Dual Antiplatelet Therapy Non-adherence associated morbidity
Description
Incidence of stroke/thrombotic events, all-cause morbidity, rehospitalization for cerebrovascular events, peri-treatment hospitalization lasting more than 15 days, and delayed discharge from hospital.
Time Frame
6 months post-procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Samuel J Ahmad, BA
Phone
7323128592
Email
samuel.ahmad@einsteinmed.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Erida Castro-Rivas, MD, MS
Email
ecastroriv@montefiore.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Altschul, MD
Organizational Affiliation
Associate Professor in The Leo M. Davidoff Department of Neurological Surgery at Montefiore
Official's Role
Principal Investigator
Facility Information:
Facility Name
Montefiore Medical Center Department of Neurosurgery
City
New York
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Altschul, MD
Phone
718-920-7498
Email
DALTSCHU@montefiore.org
First Name & Middle Initial & Last Name & Degree
Samuel J Ahmad, BA
First Name & Middle Initial & Last Name & Degree
David Altschul, MD

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.

Learn more about this trial

Dual Antiplatelet Therapy Adherence With Reminder App Usage

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