JMIR Publications

ABSTRACT

Background:

Patients with multi-morbidity and complex health needs are defined as a priority by WHO and the European Union. It has been pointed point out the need to develop appropriate strategies with effective measures to meet the challenge of chronicity, reorienting national health systems. The increasing expansion of mHealth interventions in patient communication, the reduction of health inequalities, improved access to healthcare resources, adherence to treatment, and self-care of chronic diseases, all point to an optimistic outlook. However, few mobile applications demonstrate their effectiveness in these patients, which is diminished when they are not based on evidence, nor are they designed by and for users with different levels of health literacy.

Objective:

To evaluate the efficacy of a mHealth intervention relative to routine clinical practice in improving health literacy and self-management in patients with multimorbidity with heart failure and complex health needs.

Methods:

Randomized, multicenter, blinded clinical trial for evaluation with two groups: a control group (standard clinical practice) and an intervention group (standard clinical practice and ad hoc designed mHealth intervention–previously developed in a phase lasting 18 months-) for 12 months.

Results:

The contents of the mHealth intervention are addressed 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 phase related to create and develop the contents of the mHealth intervention has been taken 18 months and It has been completed during 2021. The mobile application will have been developed by the end of 2022. Once the application has been developed, 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 application improves health literacy and self-management in patients with heart failure 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. Clinical Trial: ClinicalTrials.gov identifier: NCT04725526; https://www.clinicaltrials.gov/ct2/results?cond=&term=NCT04725526&cntry=&state=&city=&dist=