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.

• mHealth Educational Self-Management Application (Behavioral): 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 (Other): Standard multidisciplinary hospital discharge education, medication reconciliation, and scheduled outpatient follow-up provided according to institutional protocols.

Primary outcomes

• Recruitment rate [From screening until completion of recruitment]: Proportion of eligible participants who are enrolled and randomized in the trial
• Retention rate [30 and 60 days post-discharge]: Proportion of randomized participants who complete follow-up assessments
• Adherence to the mHealth intervention [30 and 60 days post-discharge]: Proportion of educational modules completed and symptom self-monitoring entries recorded in the application logs.
• Data completeness [30 and 60 days post-discharge]: Percentage of completed outcome assessments among enrolled participants
• Time required for enrollment and intervention delivery [At enrollment]: Time required to complete enrollment procedures and initial intervention delivery, measured in minutes.

Secondary outcomes

• Technology Acceptance of the Mobile Application (TAM) [60 days post-discharge]: 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 [30 days post-discharge]: 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) [Baseline, 30 days and 60 days post-discharge]: 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

Other outcomes

• Heart Failure Related Hospital Readmissions [30 and 60 days post-discharge]: Number and proportion of participants readmitted due to heart failure decompensation, verified through institutional medical record review.
• Change in NYHA Functional Class [Baseline, 30 days and 60 days post-discharge]: 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 [Baseline, 30 days and 60 days post-discharge]: 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

Sex: All, ages: 18 Years to any

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