mHealth Intervention to Support Self-care During the Hospital to Home Transition in Individuals With Heart Failure
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: mHealth Educational Self-Management Application, Usual transitional care.
- Who it may be relevant to
- Registry conditions: Heart Failure, Self-care, Transitional Care. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Colombia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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
Overview
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.
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.
Interventions
- 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. - Other Usual transitional care
Standard multidisciplinary hospital discharge education, medication reconciliation, and scheduled outpatient follow-up provided according to institutional protocols.
Primary outcome measures
- Recruitment rate [Time frame: From screening until completion of recruitment]
- Retention rate [Time frame: 30 and 60 days post-discharge]
- Adherence to the mHealth intervention [Time frame: 30 and 60 days post-discharge]
- Data completeness [Time frame: 30 and 60 days post-discharge]
- Time required for enrollment and intervention delivery [Time frame: At enrollment]
Secondary outcome measures (3)
- Technology Acceptance of the Mobile Application (TAM) [Time frame: 60 days post-discharge]
- Usability of the Mobile Application [Time frame: 30 days post-discharge]
- Change in Self-Care (SCHFI v7.2) [Time frame: Baseline, 30 days and 60 days post-discharge]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Health services research
Study locations
Colombia · 1 center
- Centro Cardiovascular Colombiano SAS — Bogotá
Identifiers
NCT: NCT07478081 · ENFPHD-2-2026