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.
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)
Life expectancy < 6 months
Severe cognitive impairment (MMSE <24 or documented dementia)
Inability to provide informed consent
Participation in another interventional study
Parallel
mHealth Educational Self-Management Application
BehavioralA 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
Other interventionStandard multidisciplinary hospital discharge education, medication reconciliation, and scheduled outpatient follow-up provided according to institutional protocols.
Recruitment rate
Proportion of eligible participants who are enrolled and randomized in the trial
Retention rate
Proportion of randomized participants who complete follow-up assessments
Adherence to the mHealth intervention
Proportion of educational modules completed and symptom self-monitoring entries recorded in the application logs.
Data completeness
Percentage of completed outcome assessments among enrolled participants
Technology Acceptance of the Mobile Application (TAM)
Technology acceptance will be measured using the Technology Acceptance Model (TAM) scale, an 11 item instrument assessing perceived usefulness, perceived ease of use, and behavioral intention to use the application. Items are rated on a 5 point Likert scale (1 = strongly disagree to 5 = strongly agree). Results will be reported as mean total score and mean subscale scores.
Usability of the Mobile Application
Usability will be assessed using two complementary methods: (a) System Usability Scale (SUS), a 10 item questionnaire scored from 0 to 100 and reported as mean total score and (b) User-Centered Cognitive Walkthrough (UC-CW), evaluating task completion rate, number and type of navigation errors, and functional understanding issues.
Change in Self-Care (SCHFI v7.2)
Self-care will be measured using the Self-Care of Heart Failure Index (SCHFI v7.2), which provides standardized scores (0-100) for maintenance, symptom perception, and management subscales. The primary metric will be change from baseline, 30 days and 60 days post-discharge
Heart Failure Related Hospital Readmissions
Number and proportion of participants readmitted due to heart failure decompensation, verified through institutional medical record review.
Change in NYHA Functional Class
Change in New York Heart Association (NYHA) functional class (I-IV), reported as proportion improved, unchanged, or worsened from baseline, 30 days and 60 days post-discharge
Change in NT-proBNP Levels
Change in NT-proBNP plasma levels (pg/mL), measured using institutional laboratory standard methods, reported as mean change from baseline to 30 days and 60 days post-discharge
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