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

This is an interventional, randomized, controlled, parallel-group pilot trial with a 1:1 allocation ratio 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 hospital-to-home transition. The study uses a single-blind design in which outcome assessors are blinded to group assignment. The intervention is behavioral and educational in nature; therefore, the study phase is classified as not applicable.

The study will be conducted at a tertiary cardiovascular referral institution. Participants will be recruited from inpatient cardiology services prior to hospital discharge and followed for 60 days after hospital discharge, with outcome assessments conducted at 30 and 60 days.

Eligible participants include adults aged 18 years or older with a diagnosis of heart failure (New York Heart Association class II or III), who are clinically stable at discharge, own a compatible smartphone, demonstrate basic digital literacy, and have an informal caregiver willing to support the intervention. Key exclusion criteria include life expectancy less than 6 months, severe cognitive impairment, inability to provide informed consent, or participation in another interventional study.

Participants will be randomly assigned (1:1) using computer-generated block randomization with variable block sizes of 4 and 6. The allocation sequence will be generated by an independent researcher not involved in recruitment or outcome assessment. Allocation concealment will be ensured through sequentially numbered, opaque, sealed envelopes.

Two study arms are defined:

Participants in the usual care group will receive standard hospital to home transitional care according to institutional protocols, including multidisciplinary discharge education, medication reconciliation, and scheduled outpatient follow-up.

Participants in the experimental group will receive usual care plus the mHealth educational self-management intervention. The intervention consists of a mobile application developed prior to study initiation and designed to strengthen heart failure self-care. Core components include tailored educational modules, symptom self-monitoring, automated feedback, behavioral reinforcement messages, caregiver integration, and secure communication with the healthcare team.

The intervention will be delivered over a 60-day period following hospital discharge. Implementation begins prior to discharge with application installation and guided education involving both the participant and caregiver. After discharge, the intervention includes intensive monitoring during week 1, reinforcement and on-demand contact during weeks 2-4, and automated monitoring with digital feedback from week 5 through day 60 post-discharge, with follow-up assessments conducted at 30 and 60 days..

Primary outcomes assess feasibility of trial procedures, technology acceptance using the technology acceptance model scale, and usability of the mobile application using the system usability scale and a user-centered cognitive walkthrough. Secondary exploratory outcomes include change in self-care measured with the Self Care of Heart Failure Index (SCHFI v7.2), heart failure-related hospital readmissions, change in New York Heart Association functional class, and change in NT-proBNP levels.

Inclusion criteria

• 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

Exclusion criteria

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