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Improving Medication Self-Administration and Health After Brain Injury

Improving Medication Self-Administration and Health After Brain Injury

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03885674
Enrollment
120
Registered
2019-03-22
Start date
2016-07-31
Completion date
2022-12-31
Last updated
2021-02-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Brain Injuries, Traumatic, Cognitive Impairment, Medication Adherence, Medication Compliance, Stroke, Stroke, Acute

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.

Interventions

OTHERVideo 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.

OTHERAutomated 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.

Sponsors

Kessler Foundation
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

Patients will be randomized to one of three intervention groups; video call reminders, automated text messages, or no intervention (standard care).

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Medication Adherence6 monthsAs measured by Medication Event Monitoring System (MEMS) trackers

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026