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mHealth Intervention to Support Self-care During the Hospital to Home Transition in Individuals With Heart Failure
Sponsor: Universidad de la Sabana
Summary
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.
Official title: Evaluation of the Feasibility, Usability, and Preliminary Effects of an mHealth Intervention Complementary to Usual Care in Individuals With Heart Failure: Protocol for a Pilot Randomized Clinical Trial
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
30
Start Date
2026-03
Completion Date
2027-06
Last Updated
2026-03-20
Healthy Volunteers
No
Conditions
Interventions
mHealth Educational Self-Management Application
A structured mobile health educational and self-management intervention delivered through a smartphone application. The intervention provides tailored heart failure education, daily and weekly symptom monitoring, automated reinforcement messages, caregiver engagement tools, and communication support with the healthcare team. The intervention is educational in nature and does not function as a regulated medical device.
Usual transitional care
Standard multidisciplinary hospital discharge education, medication reconciliation, and scheduled outpatient follow-up provided according to institutional protocols.
Locations (1)
Centro Cardiovascular Colombiano SAS
Bogotá, Bogota D.C., Colombia