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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Heart Failure; Transitional Care; Self-care
• Intervention / Treatment: Other: Usual transitional care; Behavioral: mHealth Educational Self-Management Application

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Diana M Achury; Phone Number: +57 3154847549; Email: dianaachsa@unisabana.edu.co

Study Locations

• Colombia
  • Bogota D.C.
    • Bogotá, Bogota D.C., Colombia, 0907
      • Centro Cardiovascular Colombiano SAS
      • Contact: Willian Amaya Ramirez; Phone Number: +57 3336025650; Email: conveniodocente@cencardio.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Usual Care; Participants will receive standard hospital to home transitional care, including multidisciplinary discharge education, medication reconciliation, and scheduled outpatient follow-up according to institutional protocols.	Other: Usual transitional care; Standard multidisciplinary hospital discharge education, medication reconciliation, and scheduled outpatient follow-up provided according to institutional protocols.
Experimental: mHealth educational self-management intervention; Participants will receive a mobile health (mHealth) educational self-management intervention in addition to usual care. The intervention consists of a mobile application designed to support heart failure self-care through tailored educational modules, symptom self-monitoring, automated feedback, behavioral reinforcement messages, caregiver integration, and secure communication with the healthcare team over a 60-day period following hospital discharge.	Behavioral: mHealth Educational Self-Management Application; 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	60 days post-discharge
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.	30 days post-discharge
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	Baseline, 30 days and 60 days post-discharge

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Heart Failure Related Hospital Readmissions	Number and proportion of participants readmitted due to heart failure decompensation, verified through institutional medical record review.	30 and 60 days post-discharge
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	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	Baseline, 30 days and 60 days post-discharge

Collaborators and Investigators

• Sponsor: Universidad de la Sabana

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027

Study Registration Dates

• First Submitted: February 19, 2026
• First Submitted That Met QC Criteria: March 13, 2026
• First Posted (Actual): March 17, 2026

Study Record Updates

• Last Update Posted (Actual): March 20, 2026
• Last Update Submitted That Met QC Criteria: March 17, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Heart Failure; mHealth; Self-Management; Self-care; Patient Education; Transitional Care
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Heart Failure
• Other Study ID Numbers: ENFPHD-2-2026

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified individual participant data will be shared, including demographic and baseline clinical variables, group assignment, feasibility outcomes, technology acceptance, usability measures, self-care outcomes, NYHA functional class, NT-proBNP levels, and heart failure-related readmissions. Data will be made available upon reasonable request from qualified investigators for academic and non-commercial research purposes.
• IPD Sharing Time Frame: Data will be available beginning 6 months after publication of the primary results and will remain available for a minimum of 5 years.
• IPD Sharing Access Criteria: Qualified researchers may request access by contacting the principal investigator. Requests must include a brief proposal, analysis plan, and a data use agreement. Data will be shared in a de-identified format through a secure institutional repository.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No