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

NCT07478081 | Not Yet Recruiting

• 1 other identifier: ENFPHD-2-2026
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Heart Failure; Self-care; Transitional Care

Keywords

mHealth; Heart Failure; Transitional Care; Patient Education; Self-Management; Self-care

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (3)

• Technology Acceptance of the Mobile Application (TAM)

  60 days post-discharge

• Usability of the Mobile Application

  30 days post-discharge

• Change in Self-Care (SCHFI v7.2)

  Baseline, 30 days and 60 days post-discharge

Other Outcomes (3)

• Heart Failure Related Hospital Readmissions

  30 and 60 days post-discharge

• Change in NYHA Functional Class

  Baseline, 30 days and 60 days post-discharge

• Change in NT-proBNP Levels

  Baseline, 30 days and 60 days post-discharge

Study Arms (2)

Usual Care

ACTIVE COMPARATOR

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

mHealth educational self-management intervention

EXPERIMENTAL

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

Interventions

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.

mHealth educational self-management intervention

Usual transitional care OTHER

Standard multidisciplinary hospital discharge education, medication reconciliation, and scheduled outpatient follow-up provided according to institutional protocols.

Usual Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Universidad de la Sabana: lead

Study Sites (1)

Centro Cardiovascular Colombiano SAS

Bogotá, Bogota D.C., 0907, Colombia

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Central Study Contacts

Diana M Achury

CONTACT

+57 3154847549; dianaachsa@unisabana.edu.co

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome assessors will be blinded to group allocation. Due to the nature of the intervention, participants and care providers cannot be blinded.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Parallel-group randomized controlled pilot trial with two arms (1:1 allocation): usual care versus usual care plus an mHealth educational self-management intervention.

Study Record Dates

• First Submitted: February 19, 2026
• First Posted: March 17, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: March 20, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• 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.
• 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.

Locations

CO (1)