Evaluation of the feasibility, usability, and preliminary effects of an mHealth intervention complementary to usual care in individuals with heart failure: protocol for a pilot randomized clinical trial

Background Heart failure is associated with high morbidity, frequent hospital readmissions, and impaired quality of life, particularly during the transition from hospital to home, a period in which self-care is often suboptimal. Although mobile health (mHealth) interventions have expanded as a potential complement to usual care, their sustained integration into clinical practice has been limited. Evidence suggests that this gap is related not only to technological factors but also to insufficient theoretical grounding, limited integration of user-centered approaches, and inadequate early evaluation of feasibility, acceptability, and usability. This study aims to address these gaps through the development and pilot evaluation of a theoretically grounded, user-centered mHealth intervention to support self-care during the transition from hospital to home in individuals with heart failure. Methods A randomized pilot clinical trial with parallel groups (1:1 allocation) conducted at a quaternary-level institution is described. The mHealth intervention will be developed using the Intervention Mapping approach, integrating the Situation-Specific Theory of Heart Failure Self-Care and the COM-B model, and will be designed under Human-Centered Design principles. The mobile application constitutes a single intervention with adaptive educational components, including personalized educational pathways, self-reported symptom monitoring, and automated feedback, which are part of the delivery mechanism and do not represent independent intervention arms. A total of 30 participants will be enrolled and followed for 60 days after hospital discharge, with outcome assessments conducted at 30 and 60 days. Primary outcomes focus on feasibility, technology acceptance, and usability of the intervention. Secondary exploratory outcomes include changes in self-care behaviors, functional status, heart failure related hospital readmissions and natriuretic peptide levels, using descriptive and exploratory analyses. Discussion This pilot study will generate key information on the operational feasibility of an mHealth intervention designed based on an explicit theoretical framework and centered on the user, implemented in a real clinical context. The findings will allow refinement of the intervention, optimization of methodological procedures, and estimation of parameters necessary for the design of a definitive randomized controlled trial, including aspects related to digital literacy and caregiver involvement. Trial registration The study has been approved by a human research ethics committee and will be registered on an International Clinical Trials platform. ID NCT07478081. 2026-03-20. https://clinicaltrials.gov/study/NCT07478081