Improving Medication Self-Administration and Health After Brain Injury

Kessler Foundation

Status: Unknown

Conditions: Medication Adherence; Cognitive Impairment; Stroke; Brain Injuries, Traumatic; Stroke, Acute; Medication Compliance

Treatments: Other: Video Call Reminder Condition; Other: Automated Text Message Reminder Condition

Study type: Interventional

Funder types: Other

Identifiers

NCT03885674

CBIR161RG041 (Other Grant/Funding Number)

E-623-08

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

Reminder Interventions

Experimental group

Description:

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

Treatment:

Other: Automated Text Message Reminder Condition

Other: Video Call Reminder Condition

Standard Condition

No Intervention group

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.