Improving Medication Self-Administration and Health After Brain Injury
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|ClinicalTrials.gov Identifier: NCT03885674|
Recruitment Status : Active, not recruiting
First Posted : March 22, 2019
Last Update Posted : December 8, 2020
|Condition or disease||Intervention/treatment||Phase|
|Stroke Stroke, Acute Cognitive Impairment Brain Injuries, Traumatic Medication Adherence Medication Compliance||Other: Video Call Reminder Condition Other: Automated Text Message Reminder Condition||Not Applicable|
The investigators are interested in studying how brain injury (TBI, stroke, etc.) survivors manage self-administering their medication once they return home, and are aiming to improve their medication adherence. In this six month long study, patients will be placed into one of three intervention groups 1) standard care received (usual care, no reminder provided), 2) receive a video call at time medication is to be taken, 3) receive an automated text message when medication is to be taken. The investigators aim to identify which intervention is best at helping brain injury survivors adhere to their medication schedule, with the future goal of implementing this type of reminder protocol into standard care.
Hypothesis: The investigators hypothesize that automated reminder text messages will result in MSA improvement comparable to video calls, maintained over the six month period.
Allocation to groups: Patients will be randomized to receive video calls, automated text messages, or no intervention (standard care). The randomization schedule is by computer-generated number list.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||120 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Patients will be randomized to one of three intervention groups; video call reminders, automated text messages, or no intervention (standard care).|
|Masking:||None (Open Label)|
|Official Title:||Improving Medication Self-Administration and Health After Brain Injury|
|Actual Study Start Date :||July 2016|
|Estimated Primary Completion Date :||December 2020|
|Estimated Study Completion Date :||July 2022|
Experimental: Reminder Interventions
Receive daily reminders from Kessler Foundation study personnel on when to take their medication.
Other: Video Call Reminder Condition
Receive daily video call reminders from Kessler Foundation research staff directly at the time of each medication dose and instructed to take the medication while on the video call.
Other: Automated Text Message Reminder Condition
Receive daily automated text messages at the time of each medication dose and will be instructed to take the medication at that time. Each text message reminder will also contain a photo of the medication to be taken. On a weekly basis, study personnel will contact participants in this group to make sure they are receiving the text messages appropriately.
No Intervention: Standard Condition
This group will not receive reminders on when to take their medication from Kessler Foundation staff and will receive the usual and standard care.
- Medication Adherence [ Time Frame: 6 months ]As measured by Medication Event Monitoring System (MEMS) trackers
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03885674
|United States, New Jersey|
|West Orange, New Jersey, United States, 07052|
|Principal Investigator:||AM Barrett, MD||Kessler Foundation|