NCT07478081Not yet recruiting
mHealth Intervention to Support Self-care During the Hospital to Home Transition in Individuals With Heart Failure
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
Source: ClinicalTrials.gov · Last updated 20 Mar 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- First submitted
- 19 Feb 2026
- Start date
- Mar 2026
- Primary completion date
- Jun 2027
- Lead sponsor
- Universidad de la Sabana
- Diseases
- Heart failure
- NCT number
- NCT07478081
What you commit to
- Study type: Interventional
- Planned participants: 30
- From Mar 2026 to the primary completion date, Jun 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Severe cognitive impairment (MMSE \<24 or documented dementia)
Other
- Life expectancy \< 6 months
- Inability to provide informed consent
- Participation in another interventional study
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Centro Cardiovascular Colombiano SAS Coordinator of this site? Confirm its status | Bogotá | Colombia | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.