Clinical trial NCT03885674: Improving Medication Self-Administration and Health After Brain Injury
Official title: Improving Medication Self-Administration and Health After Brain Injury
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stroke
Stroke, Acute
Cognitive Impairment
Brain Injuries, Traumatic
Medication Adherence
Medication Compliance
Lead sponsor: Kessler Foundation
Sponsor class: OTHER
First posted: 2019-03-22
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients will be randomized to one of three intervention groups; video call reminders, automated text messages, or no intervention (standard care).
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Medication Adherence
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: West Orange
country: United States
facility: Kessler Foundation
state: New Jersey
Study officials:
affiliation: Kessler Foundation
name: AM Barrett, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.