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. 2020 May 8;2020(5):CD012419. doi: 10.1002/14651858.CD012419.pub2

NCT03162848.

Methods Pilot RCT
Participants Inclusion: 50 years or older; heart failure diagnosis; prescribed diuretics; self‐administering medications; able to open an electronic cap; able to speak, hear, and understand English; not hospitalised; no cognitive impairment
Interventions Intervention: The SystemCHANGE™ intervention utilises the socioecological model and the Plan‐Do‐Check Act model as its framework and focuses on changing the individual's environment to change behaviour using small experiments with feedback. At initial home visit, the PI will work with the participant to identify important people for medication‐taking, routines, and cycles of routines. Possible solutions to incorporate medication‐taking into routines will be identified by the participant and the PI, and the participant will start to implement these solutions. Medication adherence will continuously be monitored via medication event monitoring systems. At 1 month, the participant will be sent a report on medication‐taking and a phone call with the PI will occur to discuss whether solutions improved medication adherence or whether other solutions need to be implemented. At month 2, the intervention will end but participants are urged to continue to use solutions long term
Control: usual care with education at baseline, 1 month, and 2 months
Outcomes Medication adherence using medication event monitoring systems, acceptability and feasibility using open‐ended questionnaire, systems thinking using questionnaire, Kansas City Cardiomyopathy questionnaire
Notes NCT03162848
No protocol or results published. Estimated study completion date: July 2018
Need to determine mean/median number of medications to confirm eligibility
Investigator contacted for more information ‐ no response
Investigator contacted: Angela Andrews, University of Missouri, Kansas City