Evaluation of the Adapted Adherence Improving Self-Management Strategy Intervention in Chronic Heart Failure Patients - a Randomized Controlled Trial

◦Quality assurance plan that addresses data validation and registry procedures, including any plans for site monitoring and auditing.

Data for the primary outcome medication adherence will be monitored electronically and data will be downloaded during regular clinic visits and automatically downloaded to a protected study server. The quality of electronically monitored medication adherence data depends on whether the electronic monitors are used adequately. The research team will monitor adequate use of these electronic monitors at the start of the study.

Data for secondary outcomes will be collected through questionnaires and the research team will follow-up on participants not completing those. Statistical analysis plans will be uploaded before data collection is completed and the database is accessed.

◦Data checks to compare data entered into the registry against predefined rules for range or consistency with other data fields in the registry.

The quality of electronically monitored medication adherence data depends on whether the electronic monitors are used adequately. At study exit, data will be discussed with all patients. When electronic monitoring data is completely missing or suggests very low adherence (depending on the sample distributions, but this could be e.g., <50% of doses taken) in the presence of well-controlled symptoms; and the participant self-reports poor use of the electronic monitor, then a sensitivity analysis will be conducted with those electronic monitoring data replaced by the participants' self-reported adherence.