CClinicalTrials.gg
Status unknownNCT03885674Updated Feb 17, 2021

Improving Medication Self-Administration and Health After Brain Injury

An interventional study of Video Call Reminder Condition and Automated Text Message Reminder Condition in Stroke, Stroke, Acute and Cognitive Impairment, sponsored by Kessler Foundation. Status unknown at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-02-17.

Sponsored by Kessler Foundation · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Feb 2021), so the status shown — last known as Active, not recruiting — may be out of date.

From the registry’s dates

  • Registered 2 years 8 months after the study started (first participant enrolled Jul 2016, registered Mar 2019).
Phase
Not applicable
Study type
Interventional
Enrollment
120
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Stroke
  • Stroke, Acute
  • Cognitive Impairment
  • Brain Injuries, Traumatic
  • Medication Adherence
  • Medication Compliance
03

In context

Stroke

7,286 studies on the registry are indexed under Stroke; 2,007 are open to participants now.

This study's planned enrollment of 120 is above the median of 50 across 5,369 interventional studies indexed under Stroke.

Browse Stroke studies →

Lead sponsor

Kessler Foundation is the lead sponsor of 170 studies on the registry; 58 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts 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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
120 participants (estimated)

Study arms

  • Experimental
    Reminder Interventions

    Receive daily reminders from Kessler Foundation study personnel on when to take their medication.

    Other: Video Call Reminder Condition · Other: Automated Text Message Reminder Condition

  • 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.

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.

06

What researchers measure

Primary outcomes

  1. Medication Adherence

    As measured by Medication Event Monitoring System (MEMS) trackers

    Time frame: 6 months

07

Study locations

1 site
  • Kessler Foundation
    West Orange, New Jersey 07052, United States
08

References and documents

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. PubMed 24884398 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 17, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03885674
Lead sponsor
Kessler Foundation
Responsible party
A. M. Barrett, MD (Director, Center for Stroke Rehabilitation Research, Kessler Foundation) — Principal investigator
First posted
Mar 22, 2019
Start date
Jul 2016
Primary completion
Dec 31, 2021 (estimated)
Completion
Dec 31, 2022 (estimated)
Last update
Feb 17, 2021

Study contacts

AM Barrett, MD
principal investigator · Kessler Foundation

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Feb 2021. You cannot join it, but the record below documents what was studied.

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