Improving Medication Self-Administration and Health After Brain Injury

Stroke Clinical Trial

Official title:

Improving Medication Self-Administration and Health After Brain Injury

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03885674
• Other study ID #: E-623-08
• Secondary ID: CBIR161RG041
• Status: Active, not recruiting
• Phase: N/A
• Start date: July 2016
• Est. completion date: December 31, 2022

Study information

• Verified date: February 2021
• Source: Kessler Foundation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 120
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Kessler Foundation	West Orange	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Kessler Foundation

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Medication Adherence	As measured by Medication Event Monitoring System (MEMS) trackers	6 months