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Improving Medication Self-Administration and Health After Brain Injury

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ClinicalTrials.gov Identifier: NCT03885674
Recruitment Status : Recruiting
First Posted : March 22, 2019
Last Update Posted : March 22, 2019
Sponsor:
Information provided by (Responsible Party):
A. M. Barrett, MD, 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.

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:

We 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. We 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:We 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.


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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 : July 2020
Estimated Study Completion Date : July 2022

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.



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



Information from the National Library of Medicine

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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

Information from the National Library of Medicine

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


Contacts
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Contact: Jenny R Masmela, BA 973-324-3564 jmasmela@kesslerfoundation.org

Locations
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United States, New Jersey
Kessler Foundation Recruiting
West Orange, New Jersey, United States, 07052
Contact: Jenny R Masmela, BA    973-324-3564    jmasmela@kesslerfoundation.org   
Sponsors and Collaborators
Kessler Foundation
Investigators
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Principal Investigator: AM Barrett, MD Kessler Foundation

Publications:
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Responsible Party: A. M. Barrett, MD, Director, Center for Stroke Rehabilitation Research, Kessler Foundation
ClinicalTrials.gov Identifier: NCT03885674     History of Changes
Other Study ID Numbers: E-623-08
CBIR161RG041 ( Other Grant/Funding Number: New Jersey Commission on Brain Injury Research )
First Posted: March 22, 2019    Key Record Dates
Last Update Posted: March 22, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Additional relevant MeSH terms:
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Wounds and Injuries
Stroke
Brain Injuries
Cognitive Dysfunction
Brain Injuries, Traumatic
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Craniocerebral Trauma
Trauma, Nervous System
Cognition Disorders
Neurocognitive Disorders
Mental Disorders