Feasibility and Acceptability of a SystemCHANGE™ Intervention to Improve Medication Adherence in Older Adult Stroke Survivors: A Pilot Randomized Controlled Trial
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Purpose: The purpose of this study is to evaluate the feasibility, intervention mechanism, and potential effectiveness of the SystemCHANGE™ (Change Habits by Applying New Goals and Experiences) intervention in older adult, non-adherent ischemic stroke patients. This pilot intervention study will guide future protocol refinement of a fully powered study. Significance: There has been a striking increase in the number of stroke survivors in the past two decades. Of the nearly 800,000 people who survive their first stroke each year, the risk of recurrent stroke is 15% over five years and highest in the first six months after having a stroke, emphasizing the need for early initiation of appropriate prevention therapies. The patient’s ability to adhere to a medication regimen is a key variable in preventing recurrent stroke events. Adherence intervention studies have proven marginally effective for individuals with acute and chronic illnesses, and ineffective for stroke survivors. This pilot study is the first to evaluate SystemCHANGE™ to enhance MA in stroke survivors. Data from this study will guide future protocol refinement of a fully powered study. Methods: An innovative 2-month SystemCHANGE™ intervention to enhance antithrombotic medication adherence (MA) in 30 older non-adherent stroke survivors recruited from a Midwestern neurology office using an RCT design with an attention-control group. SystemCHANGE™, grounded in the socio-ecological model, sought to systematically improve MA behaviors by identifying and shaping routines, involving supportive others in routines, and using medication-taking feedback through small patient-led experiments. Medication-taking feedback was provided, and MA was measured by electronic monitoring. The difference between the two groups during the one-month maintenance phase evaluated the efficacy of the intervention. Descriptive statistics for social support perceived health and personal systems behaviors was calculated for pre- and post-intervention measurements. Trends in medication non-adherence differences between the two groups were identified.
Table of Contents
Introduction -- Literature review: a systematic review of randomized controlled trials of medication adherence interventions in adult stroke survivors -- Methodology -- Results -- Discussion -- Appendix A. The Six-Item Screener (SIS) -- Appendix B. Demographic information form -- Appendix C. Social Support Apprasials index (SS-A) -- Appendix D Perceived health question -- Appendix E. System thinking survey -- Appendix F. Medication event monitoring -- Appendix G. Medication event monitor system (MEMS) diary -- Appendix H. MEMS® use form -- Appendix I MEMS® use survey -- Appendix J. Solutions assessment Scale -- Appendix K. SYSTEMCHANGE™ specific slices -- Appendix L Sample MEMS report -- Appendix M. Important people form -- Appendix N. Life routines form -- Appendix O. Cycles form -- Appendix P Evaluation of SYSTEMCHANGE™ goals form -- Appendix Q. Saint Luke's Health System IRB approval letter -- Appendix R. Summary of SYSTEMCHANGE™ intervention -- Appendix S. Summary of education intervention