A Pilot Randomized Controlled Trial Testing the Feasibility and Acceptability of a SystemCHANGE Intervention to Improve Medication Adherence in Older Adult Stroke Survivors.

Background: Adhering to an antithrombotic medication regimen is essential to reducing recurrent stroke in adult stroke survivors. The purpose of this study was to evaluate the feasibility and acceptability of the SystemCHANGE (SC) and attention control (AC) intervention in older adult, nonadherent ischemic stroke patients.

Methods: A pilot randomized controlled trial was conducted to determine the feasibility and acceptability of an SC versus AC intervention in older adult, nonadherent stroke survivors in the management of antithrombotic medication. Participants were masked to group assignment. Stroke survivors 50 years or older, taking at least 1 once-a-day antithrombotic medication, were recruited from a Midwest Comprehensive Stroke Center-affiliated neurology office. They were screened electronically using the Medication Event Monitoring System for 2 months to determine baseline medication adherence. Nonadherent stroke survivors (medication adherence < 0.97) were randomized to SC or AC intervention and monitored for 3 months. SC focused on redesigning the interpersonal environmental system and daily routines. The AC group was provided education materials on stroke that consisted of stroke risk factor reduction, stroke facts, rehabilitation, and nutrition with the primary investigator. Participation and intervention experience interviews were evaluated for themes.

Results: Thirty participants were recruited: median age was 64 years, 46.7% of them were male, and they took an average of 7.77 (SD, 3.191; range, 3-15) prescribed medications. The number of over-the-counter medications taken (excluding aspirin) on a regular basis averaged 1.9 (SD, 0.8; range, 1-4). Two participants were nonadherent and were randomized to the 2 arms. Both participants had positive feedback and were not inconvenienced by their participation in the study. Neither participant voiced concerns about the intervention, survey demands, time requirement, or completing the surveys on the primary investigator's laptop.

Conclusion: The SC and AC intervention protocols were feasible and acceptable to the participants in this study. Additional pilot testing is needed to further evaluate the intervention and its effect on medication adherence in this population.