mHealth Intervention to Support Self-care During the Hospital to Home Transition in Individuals With Heart Failure

This study is a pilot randomized controlled trial designed to evaluate the feasibility, acceptability, usability, and preliminary efficacy of a mobile health (mHealth) educational self-management intervention for individuals with heart failure during the transition from hospital to home. Participants will be randomly assigned in a 1:1 ratio to receive either usual care alone or usual care plus the mHealth intervention. The mobile application is designed to support heart failure self-care through tailored educational content, symptom self-monitoring, automated feedback, behavioral reinforcement messages, caregiver involvement, and secure communication with the healthcare team. The application is educational in nature and does not replace standard medical treatment. 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. Results from this pilot study will inform the design of a future definitive randomized controlled trial.

NCT Number	NCT07478081
Lead Sponsor	Universidad de la Sabana
Conditions	Heart Failure, Self-care, Transitional Care
Enrollment	30 participants
Start Date	2026-03
Primary Completion	2027-06 (estimated)
Study Completion	2027-06 (estimated)
Updated on ClinicalTrials.gov	2026-03-20