NCT03885674

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P75+ for not_applicable stroke

Timeline
Completed

Started Jul 2016

Longer than P75 for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2016

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

March 20, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 22, 2019

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

February 17, 2021

Status Verified

February 1, 2021

Enrollment Period

5.5 years

First QC Date

March 20, 2019

Last Update Submit

February 16, 2021

Conditions

StrokeStroke, AcuteCognitive ImpairmentBrain Injuries, TraumaticMedication AdherenceMedication Compliance

Outcome Measures

Primary Outcomes (1)

  • Medication Adherence

    As measured by Medication Event Monitoring System (MEMS) trackers

    6 months

Study Arms (2)

Reminder Interventions

EXPERIMENTAL

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

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

Standard Condition

NO INTERVENTION

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

Video Call Reminder ConditionOTHER

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.

Reminder Interventions
Automated Text Message Reminder ConditionOTHER

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.

Reminder Interventions

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kessler Foundation

West Orange, New Jersey, 07052, United States

Location

Related Publications (1)

  • 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.

    PMID: 24884398BACKGROUND

MeSH Terms

Conditions

StrokeCognitive DysfunctionBrain Injuries, TraumaticMedication Adherence

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesCognition DisordersNeurocognitive DisordersMental DisordersBrain InjuriesCraniocerebral TraumaTrauma, Nervous SystemWounds and InjuriesPatient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • AM Barrett, MD

    Kessler Foundation

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Patients will be randomized to one of three intervention groups; video call reminders, automated text messages, or no intervention (standard care).
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Center for Stroke Rehabilitation Research

Study Record Dates

First Submitted

March 20, 2019

First Posted

March 22, 2019

Study Start

July 1, 2016

Primary Completion

December 31, 2021

Study Completion

December 31, 2022

Last Updated

February 17, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)