Improving Medication Self-Administration and Health After Brain Injury

• ClinicalTrials.gov Identifier: NCT03885674
• Recruitment Status: Active, not recruiting
• First Posted: March 22, 2019
• Last Update Posted: February 17, 2021
• Sponsor: Kessler Foundation
• Information provided by (Responsible Party): A. M. Barrett, MD, Kessler Foundation

Study Description

Brief Summary:

The purpose of this research study is to assess medication self-administration (MSA) and the impact of three different interventions on improving medication adherence. The findings for this study may help develop evidence-based reminder protocols to reduce medication self-administration errors after brain injury.

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

Detailed Description:

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 120 participants
• Allocation: Randomized
• 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)
• Primary Purpose: Treatment
• Official Title: Improving Medication Self-Administration and Health After Brain Injury
• Actual Study Start Date: July 2016
• Estimated Primary Completion Date: December 31, 2021
• Estimated Study Completion Date: December 31, 2022

Arms and Interventions

Arm	Intervention/treatment
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.

Outcome Measures

Primary Outcome Measures :

1. Medication Adherence [ Time Frame: 6 months ]
   As measured by Medication Event Monitoring System (MEMS) trackers

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• Age greater than or equal to 18
• Less than three months post Brain Injury event
• English speaking (learned English at age 10 or younger, and use it daily)
• Currently taking up to eight medications on a daily basis

Exclusion Criteria:

• Legally blind
• Unable to give informed consent due to comprehension deficits
• Severe memory or cognitive impairments that would not allow for formal testing, as determined by the investigator
• History of psychiatric hospitalization for attempted overdose of pills

Contacts and Locations

Locations

United States, New Jersey

Kessler Foundation

West Orange, New Jersey, United States, 07052

Sponsors and Collaborators

Kessler Foundation

Investigators

• Principal Investigator: AM Barrett, MD; Kessler Foundation

More Information

Publications:

Barrett AM, Galletta EE, Zhang J, Masmela JR, Adler US. Stroke survivors over-estimate their medication self-administration (MSA) ability, predicting memory loss. Brain Inj. 2014;28(10):1328-33. doi: 10.3109/02699052.2014.915984. Epub 2014 Jun 2.

• Responsible Party: A. M. Barrett, MD, Director, Center for Stroke Rehabilitation Research, Kessler Foundation
• ClinicalTrials.gov Identifier: NCT03885674
• Other Study ID Numbers: E-623-08; CBIR161RG041 ( Other Grant/Funding Number: New Jersey Commission on Brain Injury Research )
• First Posted: March 22, 2019
• Last Update Posted: February 17, 2021
• Last Verified: February 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Stroke; Brain Injuries; Brain Injuries, Traumatic; Wounds and Injuries; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Craniocerebral Trauma; Trauma, Nervous System