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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 belowSelect...
I speak English or Spanish fluently.
Select...
I am scheduled for a stent procedure for an unruptured brain aneurysm.
Select...
I am 18 years old or older.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I cannot take certain blood thinning medications.
Select...
My blood vessels have specific physical features.
Select...
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
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.
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.
Unruptured intracranial aneurysms: development, rupture and preventive management.Update on the management of unruptured intracranial aneurysms.
Find a Location
Who is running the clinical trial?
Montefiore Medical CenterLead Sponsor
457 Previous Clinical Trials
588,612 Total Patients Enrolled
David Altschul, MDPrincipal InvestigatorAssociate Professor in The Leo M. Davidoff Department of Neurological Surgery at Montefiore
3 Previous Clinical Trials
10,279 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I cannot take certain blood thinning medications.I can travel to the research site for the study.My doctors agree that a minimally invasive procedure is right for me.I speak English or Spanish fluently.I have an aneurysm and am not on dual anti-platelet therapy.I have other health conditions that prevent me from receiving treatment.My blood vessels have specific physical features.I am scheduled for a stent procedure for an unruptured brain aneurysm.I am 18 years old or older.I do not own an iPhone.
Research Study Groups:
This trial has the following groups:- Group 1: Non-app Using Group
- Group 2: App Medication Reminder Group
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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