Aneurysm Cerebral (Unruptured)NCT05071027
Dual Antiplatelet Therapy Adherence With Reminder App Usage
A study testing Endovascular Neurosurgery in people with Aneurysm Cerebral (Unruptured), run by Montefiore Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aneurysm Cerebral (Unruptured)
- What is being tested?
- Endovascular Neurosurgery
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Oct 2021to 22 Jul 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Montefiore Medical Center Department of Neurosurgery
New York, New York, 10467
About this study
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.
Read the 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.
- Conditions
- Aneurysm Cerebral (Unruptured)
- Being tested
- Endovascular Neurosurgery
- Keywords
- aneurysm, unruptured, antiplatelet, adherence, reminder, medication, DAPT
- Medical subject headings
- Intracranial Aneurysm, Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endovascular NeurosurgeryOther
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.
| Study group | Role | What they receive |
|---|---|---|
| App Medication Reminder Group | Experimental | Patients in this group will receive dual antiplatelet medication reminders. Receives: Other: Endovascular Neurosurgery |
| Non-app Using Group | No 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day of Procedure, 2-4 weeks post-procedure, 6 months post-procedure
Secondary outcomes (2)
Dual Antiplatelet Therapy Non-adherence Associated Mortality
Mortality data associated with non-adherence to Dual Antiplatelet Therapy is summarized by study arm/group.
Measured: 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.
Measured: Up to 6 months post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2021
- Study start27 Oct 2021
- Primary completion22 Jul 2024
- Study completion22 Jul 2024
Why it stopped: The PI is discontinuing the study since the platform/Application is no longer available for use. Study terminated effective 7/29/2024.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Aneurysm Cerebral (Unruptured)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Montefiore Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David Altschul, MD, Principal investigator, Associate Professor in The Leo M. Davidoff Department of Neurological Surgery at Montefiore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05071027
- Sponsor's protocol ID
- 2021-13195
- Status last verified
- Sep 2024
- First submitted
- 23 Sep 2021
- Last updated
- 15 Nov 2024
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dual Antiplatelet Therapy Adherence With Reminder App Usage
- ClinicalTrials.gov ID
- NCT05071027
- Acronym / sponsor ID
- 2021-13195
- Conditions
- Aneurysm Cerebral (Unruptured)
- Keywords
- aneurysm, unruptured, antiplatelet, adherence, reminder, medication, DAPT
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The PI is discontinuing the study since the platform/Application is no longer available for use. Study terminated effective 7/29/2024.
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Montefiore Medical CenterUniversity, hospital or other
- Study start
- 27 Oct 2021 (actual)
- Primary completion
- 22 Jul 2024 (actual)
- Study completion
- 22 Jul 2024 (actual)
- First posted
- 7 Oct 2021 (actual)
- Results
- Posted 15 Nov 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| App Medication Reminder Group | Experimental | Other: Endovascular NeurosurgeryPatients in this group will receive dual antiplatelet medication reminders. |
| Non-app Using Group | No 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Endovascular NeurosurgeryCustom 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. | Other | App Medication Reminder Group |
Primary outcome
Change in Medication Adherence
Time frame: Day of Procedure, 2-4 weeks post-procedure, 6 months post-procedure
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.
2 secondary outcomes
Dual Antiplatelet Therapy Non-adherence Associated Mortality
Time frame: Up to 6 months post-procedure
Dual Antiplatelet Therapy Non-adherence Associated Morbidity and Related Adverse Events
Time frame: Up to 6 months post-procedure
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Altschul, MD principal investigator
Associate Professor in The Leo M. Davidoff Department of Neurological Surgery at Montefiore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endovascular Neurosurgery in people with Aneurysm Cerebral (Unruptured), run by Montefiore Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 15 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Nov 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Medication Adherence (time frame: Day of Procedure, 2-4 weeks post-procedure, 6 months post-procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2024.