What side effects are associated with this type of intervention?

Common treatments for cerebral aneurysms, particularly those involving antiplatelet therapy, include medications like aspirin and clopidogrel. Known side effects of these treatments can include bleeding complications, gastrointestinal issues, and, less commonly, allergic reactions. In the context of endovascular treatments, such as stent-assisted coiling, side effects may include thromboembolic events, intraprocedural hemorrhage, and post-procedure headaches. Adherence to medication regimens is crucial to minimize these risks and improve outcomes.

What prior FDA approvals exist?

FDA-approved treatments for cerebral aneurysms often involve the use of antiplatelet medications to prevent clot formation and ensure the patency of stents used in endovascular procedures. Drugs such as aspirin and clopidogrel are commonly prescribed for this purpose. These medications are crucial in the management of patients who have undergone stent-based endovascular treatments, as they help prevent thromboembolic complications. The use of medication reminder apps, like the one studied in the trial, aims to improve adherence to these critical medications, thereby enhancing treatment outcomes and reducing the risk of complications.

What other types of research exist?

Promising alternatives to a medication reminder app for cerebral aneurysm patients in 2024 include: 1) Smart pill bottles that track and remind patients to take their medication, 2) Wearable devices that monitor health metrics and provide medication reminders, 3) Telemedicine platforms offering remote consultations and follow-ups, and 4) Personalized patient education programs that provide tailored information and support.

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Medication Reminder App for Aneurysms

N/A

Waitlist Available

Led By David Altschul, MD

Research Sponsored by Montefiore Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Must speak either English or Spanish fluently

Elective stent-based procedures for unruptured cervical, and intracranial, intradural aneurysms

Must not have

Presence of contraindications to Dual Antiplatelet Therapy

Presence of certain vessel anatomical characteristics

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 6 months post-procedure

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a reminder app to help patients with specific brain aneurysms remember to take their medication. The app sends notifications to ensure they take their medicine on time, aiming to improve adherence and prevent complications.

Who is the study for?

This trial is for adults who can visit the research site, speak English or Spanish fluently, and are scheduled for elective stent-based procedures to treat unruptured cervical and intracranial aneurysms. It's not for those without an iPhone, where treatment doesn't involve dual antiplatelet therapy, with conditions preventing treatment, contraindications to such therapy, or certain vessel anatomical characteristics.

What is being tested?

The study tests if a medication reminder app improves adherence to Dual Antiplatelet Therapy in patients having endovascular surgery for aneurysms. Participants will be randomly assigned either to use the app alongside standard care or receive only standard care without the app.

What are the potential side effects?

While this trial focuses on using an app rather than a drug intervention directly, side effects may relate more to potential issues with using technology like stress from reminders or frustration if there are technical difficulties.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I speak English or Spanish fluently.

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I am scheduled for a stent procedure for an unruptured brain aneurysm.

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I cannot take certain blood thinning medications.

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My blood vessels have specific physical features.

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I have an aneurysm and am not on dual anti-platelet therapy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 6 months post-procedure

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 6 months post-procedure

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 6 months post-procedure for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Medication Adherence

Secondary study objectives

Dual Antiplatelet Therapy Non-adherence Associated Morbidity and Related Adverse Events

Dual Antiplatelet Therapy Non-adherence Associated Mortality

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: App Medication Reminder GroupExperimental Treatment1 Intervention

Patients in this group will receive dual antiplatelet medication reminders.

Group II: Non-app Using GroupActive Control1 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.

0 / 6Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for cerebral aneurysms include surgical clipping, endovascular coiling, and flow diversion. Surgical clipping involves placing a metal clip at the base of the aneurysm to prevent blood flow into it, effectively isolating it from the normal circulation. Endovascular coiling uses a catheter to place coils inside the aneurysm, promoting blood clotting and reducing the risk of rupture. Flow diversion involves placing a stent in the parent artery to divert blood flow away from the aneurysm, allowing it to heal. These treatments are crucial as they aim to prevent aneurysm rupture, which can lead to severe neurological damage or death. Adherence to prescribed medications, such as antiplatelet therapy post-procedure, is essential to prevent complications like clot formation or stent occlusion. The use of a medication reminder app can significantly improve adherence, ensuring the effectiveness of the treatment and enhancing patient outcomes.

Unruptured intracranial aneurysms: development, rupture and preventive management.Update on the management of unruptured intracranial aneurysms.