Trial Outcomes & Findings for Dual Antiplatelet Therapy Adherence With Reminder App Usage (NCT NCT05071027)
NCT ID: NCT05071027
Last Updated: 2024-11-15
Results Overview
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.
TERMINATED
NA
9 participants
Day of Procedure, 2-4 weeks post-procedure, 6 months post-procedure
2024-11-15
Participant Flow
1 patient died prior to being administered the application. They were randomized into the "App Medication Reminder Group" but never received the application.
Participant milestones
| Measure |
App Medication Reminder Group
Patients in this group will receive dual antiplatelet medication reminders.
Endovascular Neurosurgery: 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.
|
Non-app Using Group
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.
|
|---|---|---|
|
Overall Study
STARTED
|
3
|
6
|
|
Overall Study
COMPLETED
|
2
|
2
|
|
Overall Study
NOT COMPLETED
|
1
|
4
|
Reasons for withdrawal
| Measure |
App Medication Reminder Group
Patients in this group will receive dual antiplatelet medication reminders.
Endovascular Neurosurgery: 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.
|
Non-app Using Group
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.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
4
|
Baseline Characteristics
Dual Antiplatelet Therapy Adherence With Reminder App Usage
Baseline characteristics by cohort
| Measure |
App Medication Reminder Group
n=3 Participants
Patients in this group will receive dual antiplatelet medication reminders.
Endovascular Neurosurgery: 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.
|
Non-app Using Group
n=6 Participants
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.
|
Total
n=9 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
White, Spanish/Hispanic/Latino
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Black or African-American
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Spanish/Hispanic/Latino
|
0 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Other, Not Spanish/Hispanic/Latino
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
3 participants
n=99 Participants
|
6 participants
n=107 Participants
|
9 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Day of Procedure, 2-4 weeks post-procedure, 6 months post-procedurePopulation: Data related to 'Change in Medication Adherence' was unable to be collected in order to obtain an Adherence Barrier Questionnaire Score and, as such, this Outcome was unable to be evaluated.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 6 months post-procedurePopulation: Two participants in each arm/group were able to be evaluated for Dual Antiplatelet Therapy Non-adherence associated mortalities. Other participants were lost to follow up.
Mortality data associated with non-adherence to Dual Antiplatelet Therapy is summarized by study arm/group.
Outcome measures
| Measure |
App Medication Reminder Group
n=2 Participants
Patients in this group will receive dual antiplatelet medication reminders.
Endovascular Neurosurgery: 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.
|
Non-app Using Group
n=2 Participants
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.
|
|---|---|---|
|
Dual Antiplatelet Therapy Non-adherence Associated Mortality
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 6 months post-procedurePopulation: Two participants in each arm/group were able to be evaluated for Dual Antiplatelet Therapy Non-adherence associated mortalities. Other participants were lost to follow up.
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.
Outcome measures
| Measure |
App Medication Reminder Group
n=2 Participants
Patients in this group will receive dual antiplatelet medication reminders.
Endovascular Neurosurgery: 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.
|
Non-app Using Group
n=2 Participants
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.
|
|---|---|---|
|
Dual Antiplatelet Therapy Non-adherence Associated Morbidity and Related Adverse Events
|
0 Participants
|
0 Participants
|
Adverse Events
App Medication Reminder Group
Non-app Using Group
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. David Altschul, Department of Neurosurgery
Montefiore Medical Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place