Improving Medication Self-Administration and Health After Brain Injury

Not Applicable

• Conditions: Cognitive Impairment; Medication Adherence; Medication Compliance; Stroke; Brain Injuries, Traumatic; Stroke, Acute

• Registration Number: NCT03885674
• Lead Sponsor: Kessler Foundation

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.

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 Timeline

• Study Start: 2016-07
• Study First Submitted: 2019-03-20
• Study First Submitted QC: 2019-03-20
• Study First Posted: 2019-03-22
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-16
• Last Update Posted: 2021-02-17
• Primary Completion: 2021-12-31
• Study Completion: 2022-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Medication Adherence	6 months	As measured by Medication Event Monitoring System (MEMS) trackers

Trial Locations

Locations (1)

Kessler Foundation; 🇺🇸 West Orange, New Jersey, United States