Acceptability and feasibility of the NPS MedicineWise mobile phone application in supporting medication adherence in patients with chronic heart failure: Protocol for a pilot study.

Introduction: Heart failure (HF) is an increasing global concern. Despite evidence-based pharmacotherapy, morbidity and mortality remain high in HF. Medication non-adherence is a crucial factor in optimising clinical outcomes. A growing number of smartphone applications (apps) assist management. While evidence support their use to promote treatment adherence, apps alone may not be the solution. The objective of this pilot study is to assess the acceptability and feasibility of a tiered intervention added to the NPS MedicineWise dose reminder app (MedicineWise app) in supporting medication adherence in HF.

Methods And Analysis: This prospective, single-blinded, randomised controlled trial will recruit 55 Australian patients with HF to be randomly assigned to either intervention (MedicineWise app + usual care) or control (usual care alone) arm. Control participants will remain unaware of the intervention throughout the study. At baseline, intervention participants will be instructed in the MedicineWise app. A reminder will then prompt medication administration at each dosing interval. If non-adherence is suggested from 24 hourly reports (critical medications) or 72 hours (non-critical medications), the individual/s will be escalated through a tiered, pharmacist-led intervention. The primary outcome will be the acceptability and feasibility of this approach in supporting adherence. Between-group comparison of the Self-Efficacy for Appropriate Medication Use Scale (SEAMS) at baseline, 3 and 6 months will be used to measure the app's value in supporting adherence. Secondary outcome measures include self-reported medication adherence and knowledge, health-related quality of life, psychological wellbeing, signs and symptoms of HF, and medication and HF knowledge.

Ethics And Dissemination: The protocol received ethics approval from Central Adelaide Clinical Human Research Ethics Committee (Protocol number R20190302) and University of South Australia Human Research Ethics Committee (Protocol number 202450). Findings will be disseminated through peer-reviewed journals.

Trial Registration Number: Australian New Zealand Clinical Trials Registry Clinical trial number: ACTRN12619000289112p (http://www.ANZCTR.org.au/ACTRN12619000289112p.aspx).