NCT04725526

Efficiency of an mHealth Intervention on the Health Literacy Improvement and Self-management.

Development and Efficiency of an mHealth Intervention on the Health Literacy Improvement and Self-management of the Multi-pathological Patient With Heart Failure: a Randomized Controlled Trial.

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 236 (estimated)
• Sponsor: Instituto de investigación e innovación biomédica de Cádiz · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Multipathological patients with complex health needs are responsible for the majority number of avoidable hospital admissions. The expansion of mHealth interventions in the field of communication with the patient, the reduction of health inequalities, the improvement in access to health resources, the adherence to treatments and self-care of chronic diseases lead to an optimistic horizon . However, there are few applications that demonstrate its effectiveness in these patients, which is diminished when they are not based on evidence, nor are designed by and for users with different levels of health literacy.

Detailed description

Objective: to evaluate the efficacy of an mHealth intervention, with respect to routine clinical practice, to improve health literacy and self-management of the multiple pathological patient with heart failure and complex health needs. Hypothesis: the proposed mHealth intervention is more effective than usual clinical practice, favoring health literacy and self-management of multiple pathological patients with heart failure and complex health needs, so its use would be relevant as part of the assistance process. Methodology: randomized, controlled, multicenter clinical trial for the evaluation of the efficacy of an mHealth intervention with two groups: a control group (routine clinical practice) and an experimental group (routine clinical practice together with ad hoc designed mHealth intervention). In this project, the design and content validation of the mHealth tool will be carried out, evaluating its relevance and suitability.

Conditions

• Heart Failure
• Multi-pathology

Interventions

Type	Name	Description
DEVICE	Mobile phone compatible with iOS or Android	MHealth (mobile health) intervention is an act whose purpose is to improve, maintain, promote or modify health, functioning or health conditions.

Timeline

• Start date: 2020-03-01
• Primary completion: 2023-01-01
• Completion: 2024-01-01
• First posted: 2021-01-26
• Last updated: 2022-08-08

Locations

2 sites across 1 country: Spain