Heart FailureHF-mHealthNCT07478081
mHealth Intervention to Support Self-care During the Hospital to Home Transition in Individuals With Heart Failure
A study testing mHealth Educational Self-Management Application and Usual transitional care in people with Heart Failure and Self-care, run by Universidad de la Sabana at 1 site in Colombia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Self-care, Transitional Care
- What is being tested?
- mHealth Educational Self-Management Application and Usual transitional care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteColombia
- Study dates
- Mar 2026to Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Life expectancy < 6 months
- Severe cognitive impairment (MMSE <24 or documented dementia)
- Inability to provide informed consent
- Participation in another interventional study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Colombia1 site
Centro Cardiovascular Colombiano SAS
Bogotá, Bogota D.C., 0907
Willian Amaya Ramirez, +57 3336025650, conveniodocente@cencardio.com
About this study
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
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.
Read the 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.
- Conditions
- Heart Failure, Self-care, Transitional Care
- Being tested
- mHealth Educational Self-Management Application, Usual transitional care
- Keywords
- mHealth, Heart Failure, Transitional Care, Patient Education, Self-Management, Self-care
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mHealth Educational Self-Management ApplicationBehavioural
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 careOther
Standard multidisciplinary hospital discharge education, medication reconciliation, and scheduled outpatient follow-up provided according to institutional protocols.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: mHealth Educational Self-Management Application |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment rate
Proportion of eligible participants who are enrolled and randomized in the trial
Measured: From screening until completion of recruitment
Retention rate
Proportion of randomized participants who complete follow-up assessments
Measured: 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.
Measured: 30 and 60 days post-discharge
Data completeness
Percentage of completed outcome assessments among enrolled participants
Measured: 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.
Measured: At enrollment
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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
Measured: Baseline, 30 days and 60 days post-discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2026
- Study startMar 2026 (estimated)
- Primary completionJun 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel-group randomized controlled pilot trial with two arms (1:1 allocation): usual care versus usual care plus an mHealth educational self-management intervention.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad de la Sabana
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07478081
- Sponsor's protocol ID
- ENFPHD-2-2026
- Acronym
- HF-mHealth
- Status last verified
- Mar 2026
- First submitted
- 19 Feb 2026
- Last updated
- 20 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07478081
- Acronym / sponsor ID
- HF-mHealth / ENFPHD-2-2026
- Conditions
- Heart Failure, Self-care, Transitional Care
- Keywords
- mHealth, Heart Failure, Transitional Care, Patient Education, Self-Management, Self-care
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Universidad de la SabanaUniversity, hospital or other
- Study start
- Mar 2026 (estimated)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 17 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Parallel-group randomized controlled pilot trial with two arms (1:1 allocation): usual care versus usual care plus an mHealth educational self-management intervention.
| Arm | Type | Receives |
|---|---|---|
| Usual Care | Active comparator | Other: Usual transitional careParticipants will receive standard hospital to home transitional care, including multidisciplinary discharge education, medication reconciliation, and scheduled outpatient follow-up according to institutional protocols. |
| mHealth educational self-management intervention | Experimental | Behavioral: mHealth Educational Self-Management ApplicationParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- Life expectancy < 6 months
- Severe cognitive impairment (MMSE <24 or documented dementia)
- Inability to provide informed consent
- Participation in another interventional study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mHealth Educational Self-Management ApplicationA 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. | Behavioural | mHealth educational self-management intervention |
| Usual transitional careStandard multidisciplinary hospital discharge education, medication reconciliation, and scheduled outpatient follow-up provided according to institutional protocols. | Other | Usual Care |
Primary outcome
Recruitment rate
Time frame: From screening until completion of recruitment
Proportion of eligible participants who are enrolled and randomized in the trial
Retention rate
Time frame: 30 and 60 days post-discharge
Proportion of randomized participants who complete follow-up assessments
Adherence to the mHealth intervention
Time frame: 30 and 60 days post-discharge
Proportion of educational modules completed and symptom self-monitoring entries recorded in the application logs.
Data completeness
Time frame: 30 and 60 days post-discharge
Percentage of completed outcome assessments among enrolled participants
Time required for enrollment and intervention delivery
Time frame: At enrollment
Time required to complete enrollment procedures and initial intervention delivery, measured in minutes.
3 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2026.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mHealth Educational Self-Management Application and Usual transitional care in people with Heart Failure and Self-care, run by Universidad de la Sabana at 1 site in Colombia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 20 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Colombia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Diana M Achury (+57 3154847549, dianaachsa@unisabana.edu.co), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment rate (time frame: From screening until completion of recruitment). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2026.