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Improving Medication Self-Administration and Health After Brain Injury

Primary Purpose

Stroke, Stroke, Acute, Cognitive Impairment

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Video Call Reminder Condition
Automated Text Message Reminder Condition
Sponsored by
Kessler Foundation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Kessler Foundation

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Reminder Interventions

Standard Condition

Arm Description

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

This group will not receive reminders on when to take their medication from Kessler Foundation staff and will receive the usual and standard care.

Outcomes

Primary Outcome Measures

Medication Adherence
As measured by Medication Event Monitoring System (MEMS) trackers

Secondary Outcome Measures

Full Information

First Posted
March 20, 2019
Last Updated
February 16, 2021
Sponsor
Kessler Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT03885674
Brief Title
Improving Medication Self-Administration and Health After Brain Injury
Official Title
Improving Medication Self-Administration and Health After Brain Injury
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Unknown status
Study Start Date
July 2016 (Actual)
Primary Completion Date
December 31, 2021 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kessler Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Stroke, Acute, Cognitive Impairment, Brain Injuries, Traumatic, Medication Adherence, Medication Compliance

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Reminder Interventions
Arm Type
Experimental
Arm Description
Receive daily reminders from Kessler Foundation study personnel on when to take their medication.
Arm Title
Standard Condition
Arm Type
No Intervention
Arm Description
This group will not receive reminders on when to take their medication from Kessler Foundation staff and will receive the usual and standard care.
Intervention Type
Other
Intervention Name(s)
Video Call Reminder Condition
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Automated Text Message Reminder Condition
Intervention Description
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.
Primary Outcome Measure Information:
Title
Medication Adherence
Description
As measured by Medication Event Monitoring System (MEMS) trackers
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
AM Barrett, MD
Organizational Affiliation
Kessler Foundation
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kessler Foundation
City
West Orange
State/Province
New Jersey
ZIP/Postal Code
07052
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
24884398
Citation
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.
Results Reference
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Improving Medication Self-Administration and Health After Brain Injury

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