RT journal article T1 Development and Effectiveness of a Mobile Health Intervention in Improving Health Literacy and Self-management of Patients With Multimorbidity and Heart Failure: Protocol for a Randomized Controlled Trial A1 Bas Sarmiento, María del Pilar A1 Fernández Gutiérrez, Martina A1 Poza Méndez, Miriam A1 Marín Paz, Antonio Jesús A1 Paloma Castro, Olga A1 Romero Sánchez, José Manuel A1 ASyAG_PPIC Team A2 Enfermería y Fisioterapia K1 Health Literacy K1 mHealth K1 RCT K1 Self-Management K1 Multimorbidity K1 Heart Failure K1 Randomized Controlled Trial K1 Mobile App AB - Background: Patients with multimorbidity and complex health needs are defined as a priority by the World Health Organization (WHO) and the European Union. There is a need to develop appropriate strategies with effective measures to meet the challenge of chronicity, reorienting national health systems. The increasing expansion of mobile health (mHealth) interventions in patient communication, the reduction of health inequalities, improved access to health care resources, adherence to treatment, and self-care of chronic diseases all point to an optimistic outlook. However, only few mobile apps demonstrate their effectiveness in these patients, which is diminished when they are not based on evidence, or when they are not designed by and for users with different levels of health literacy (HL).- Objective: This study aims to evaluate the efficacy of an mHealth intervention relative to routine clinical practice in improving HL and self-management in patients with multimorbidity with heart failure (HF) and complex health needs.- Methods: This is a randomized, multicenter, blinded clinical trial evaluating 2 groups, namely, a control group (standard clinical practice) and an intervention group (standard clinical practice and an ad hoc designed mHealth intervention previously developed), for 12 months.- Results: The contents of the mHealth intervention will address user-perceived needs based on the development of user stories regarding diet, physical exercise, cardiac rehabilitation, therapeutic adherence, warning signs and symptoms, and emotional management. These contents have been validated by expert consensus. The creation and development of the contents of the mHealth intervention (app) took 18 months and was completed during 2021. The mobile app is expected to be developed by the end of 2022, after which it will be applied to the experimental group as an adjunct to standard clinical care during 12 months.- Conclusions: The trial will demonstrate whether the mobile app improves HL and self-management in patients with HF and complex health needs, improves therapeutic adherence, and reduces hospital admissions. This study can serve as a starting point for developing other mHealth tools in other pathologies and for their generalization to other contexts. SN 1929-0748 YR 2022 FD 2022-04-29 LK http://hdl.handle.net/10498/26963 UL http://hdl.handle.net/10498/26963 LA eng NO Trial Registration: ClinicalTrials.gov NCT04725526 DS Repositorio Institucional de la Universidad de Cádiz RD 21-sep-2026