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

Starting soon · Not applicable

Conditions studied: Heart Failure, Self-care, Transitional Care

In brief

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.

Key facts

Study ID

NCT07478081

Run by

Universidad de la Sabana

People needed

30

Starts

2026-03-01

Expected to finish

2027-06-01

Last updated by the study team

2026-03-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age ≥ 18 years
• Diagnosis of heart failure (NYHA Class II or III)
• Clinically stable at discharge (no IV inotropes within 48 hours; hemodynamically stable)
• Ownership of compatible smartphone (Android/iOS)
• Basic digital literacy
• Availability of informal caregiver willing to support the process

You may not qualify if…

• Life expectancy < 6 months
• Severe cognitive impairment (MMSE <24 or documented dementia)
• Inability to provide informed consent
• Participation in another interventional study

Where it is running

• Centro Cardiovascular Colombiano SAS — Bogotá, Bogota D.C., Colombia

Full record on ClinicalTrials.gov

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