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Medication Reminder App for Aneurysms
N/A
Recruiting
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
Physically able to come to the research site location
Endovascular therapy must be deemed appropriate by clinical team
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months post-procedure
Awards & highlights
Study Summary
This trial is testing whether a medication reminder app can help people with unruptured aneurysms take their medication as prescribed.
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.Check my eligibility
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.See study design
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 can travel to the research site for the study.
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My doctors agree that a minimally invasive procedure is right for me.
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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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months post-procedure
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months post-procedure
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Medication Adherence
Secondary outcome measures
Dual Antiplatelet Therapy Non-adherence associated morbidity
Dual Antiplatelet Therapy Non-adherence associated mortality
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.
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Who is running the clinical trial?
Montefiore Medical CenterLead Sponsor
440 Previous Clinical Trials
581,543 Total Patients Enrolled
David Altschul, MDPrincipal InvestigatorAssociate Professor in The Leo M. Davidoff Department of Neurological Surgery at Montefiore
2 Previous Clinical Trials
10,000 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: App Medication Reminder Group
- Group 2: Non-app Using 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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are new participants still being enrolled in this research project?
"Affirmative, the information on clinicaltrials.gov verifies that this medical trial is still enrolling participants. The original posting was made on October 27th 2021; it has been updated as recently as December 13th 2021. This research call for 68 patient volunteers at 1 site of operation."
Answered by AI
How many participants are currently enrolled in this research program?
"Affirmative. The information on clinicaltrials.gov confirms that this experiment, initially posted on October 27th 2021, is presently seeking participants. 68 patients from a single medical centre need to be recruited for the trial."
Answered by AI
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