mHealth Intervention to Support Self-care During the Hospital to Home Transition in Individuals With Heart Failure (NCT07478081)
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
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Centro Cardiovascular Colombiano SAS — Bogotá, Bogota D.C.
Age range: 18 Years
🧪 Interventions in This Study
- mHealth Educational Self-Management Application (BEHAVIORAL)
- Usual transitional care (OTHER)
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (1 Sites)
- Centro Cardiovascular Colombiano SAS — Bogotá, Bogota D.C.
📞 Contact the Study Coordinator
Phone: +57 3154847549
Email: dianaachsa@unisabana.edu.co
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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Explore by condition: All Heart Failure clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.