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.

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.

Trial Registration: ClinicalTrials.gov NCT04725526; https://tinyurl.com/bd8va27w.

International Registered Report Identifier (irrid): DERR1-10.2196/35945.