Heart FailureiCardia4HFNCT06205225
iCardia4HF: Multi-component mHealth Intervention for Patients With Heart Failure
A study testing Text4HF, MyApps and MyApps & Text4HF in people with Heart Failure, run by University of Illinois Chicago at 2 sites in United States.
Trial summary
The goal of this factorial randomized trial is to examine the independent and synergistic efficacies of two mobile health technology interventions in people with chronic heart failure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- Text4HF, MyApps and MyApps & Text4HF
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 360 participants
- Where
- 2 sitesUnited States
- Study dates
- 4 Oct 2024to 30 Sep 2028
- 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
- Diagnosis of Stage C Heart Failure
- ≥ 18 years of age
- Transthoracic Echocardiogram or Cardiac MRI performed in the last 3 years and LVEF results available
- Patient is actively treated with oral loop diuretics for chronic heart failure
- Hospitalization due to acute decompensated heart failure within 24 months before randomization and/or insufficient self-care per SCHFI assessment (score of ≤3, in at least two items of the SCHFI v7.2 maintenance, symptom monitoring, or self-care management subscale)
- Ability to speak and read English
Who cannot join
- Implanted ventricular assist device
- High urgent listed for heart transplantation
- Acute coronary syndrome within the last 7 days before randomization
- Revascularization and/or CRT implantation within 28 days before randomization
- Planned revascularization, transcatheter aortic valve implantation, MitraClip and/or CRT implantation within 3 months after randomization
- End-stage HF (hospice candidate)
Show all 18Show fewer
- Discharge to a setting other than home
- Individuals who have a home nurse or are not able to take care of self (eat, dress, walk, bathe, take medications, or use the toilet)
- Chronic renal insufficiency with hemodialysis or estimated Glomerular Filtration Rate <25 mL
- Active cancer, currently undergoing treatment (e.g. radiation immunotherapy)
- Existence of any disease reducing life expectancy to less than 1 year
- Cognitive impairment (e.g., Dementia, Parkinson disease, Alzheimer disease, MoCA<18, impaired self-determination, lacking ability to communicate)
- Major physical impairment (e.g., inability to walk, bound on a wheelchair)
- Unwillingness to use study equipment
- Active substance abuse
- Currently pregnant, less than 3-month post-partum or pregnancy anticipated during the study
- Participation in other treatment studies or remote patient management programs
- Participation in the iCardia4H pilot trial (conducted before this study)
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Rush University Medical Center
Chicago, Illinois, 60612
Sachin Vispute, MPH, MSEd, 312-947-3870, Sachin_Vispute@rush.edu
Todd Ruppar, PhD
- Recruiting
University of Illinois Hospital & Health Sciences System
Chicago, Illinois, 60612
Mike Haniff, PhD, 312-413-4227, mhanif6@uic.edu
Spyros Kitsiou, PhD
About this study
Official title: iCardia4HF: A Multi-component mHealth App and Tailored Text-messaging Intervention to Promote Self-care Adherence and Improve Health Outcomes in Patients With Chronic Heart Failure
The goal of this factorial randomized trial is to examine the independent and synergistic efficacies of two mobile health technology interventions in people with chronic heart failure. The first intervention involves the use of multiple consumer mHealth apps and sensor devices (MyApps) for heart failure self-care (maintenance, monitoring, and management). The second intervention is a program of tailored text messages (Text4HF) targeting modifiable behavioral factors associated with heart failure self-care non-adherence. The main questions this study aims to answer are:
- Can the use of consumer mHealth apps and devices (MyApps) improve heart failure self-care and reduce days lost due to cardiovascular hospitalization or death for any cause?
- Can a program of individually tailored text messages (Text4HF) improve heart failure self-care and reduce the days lost due to cardiovascular hospitalization or death for any cause?
- Can MyApps and Text4HF combined lead to greater improvements in heart failure self-care and days lost due to cardiovascular hospitalization or death for any cause
Read the detailed description
Heart failure (HF) remains one of the most frequent principal diagnoses for hospitalization and a leading cause of death in the United States. Up to 65% of HF readmissions are the result of insufficient self-care. Existing HF self-care interventions delivered face-to-face or via telephone have had limited impact and reach. They require significant provider time and are not always accessible to patients. There is an urgent need for accessible and scalable interventions that are designed to assist patients with HF self-care while in the community to reduce HF readmissions. Consumer mobile health (mHealth) technologies (e.g., mobile apps and sensor devices) hold promise for promoting HF self-care and expanding intervention delivery. However, their efficacy remains largely underexplored.
To address this gap, our team developed a patient-centered HF self-care intervention (iCardia4HF) that combines the use of three consumer mobile health apps and connected health devices (MyApps) with a program of individually tailored text messages (Text4HF) targeting modifiable behavioral factors to promote HF self-care adherence and improve clinical outcomes.
This study aims to conduct a fully powered, 2x2 factorial randomized controlled trial to determine the independent and combined efficacy of the two iCardia4HF intervention components (MyApps and Text4HF) at 6 months, as well as their maintenance efficacy at 6 months post-intervention. A total of 360 patients with HF will be recruited and randomized to one of four conditions for 12 months: (1) Usual care, (2) Text4HF, (3) MyApps, or (4) MyApps\&Text4HF. Specific aims are:
Aim 1: Determine the independent and combined efficacies of MyApps and Text4HF at 6-months on the primary outcome of days lost due to cardiovascular hospitalization or death for any cause, and secondary outcomes of HF self-care and health status.
Hypothesis 1a: MyApps and Text4HF will have significant main effects on the primary outcome at 6 months.
Hypothesis 1b: MyApps and Text4HF will have significant main effects on objectively assessed measures of HF self-care adherence, self-reported HF self-care, and health status, at 6 months.
Aim 2: Determine the independent and combined maintenance efficacies of MyApps and Text4HF at 12 months (6 months post-intervention).
Hypothesis 2a: Text4HF and MyApps will have significant main effects on the primary outcome at 12 months.
Hypothesis 2b: Text4HF and MyApps will have significant main effects on objectively assessed measures of HF self-care adherence, self-reported HF self-care, and health status, at 12 months.
Aim 3: Investigate the mediating effect of intervention targets (health beliefs, HF knowledge, self-efficacy), and moderating effect of multi-level determinants of HF self-care adherence on the efficacy of the intervention, across individual (e.g., age, race/ethnicity), illness-related (e.g., depression, comorbidities), and socioeconomic factors (e.g., insurance, income, employment, and access to care).
Impact statement: This study will provide important new knowledge that will critically shape our understanding about the potential of commercially available mHealth technologies and tailored text messages to improve HF self-care adherence and reduce hospital readmissions in patients with HF.
- Conditions
- Heart Failure
- Being tested
- Text4HF, MyApps, MyApps & Text4HF, Enhanced Usual Care
- Keywords
- mHealth, wearables, mobile apps, heart failure
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Text4HFBehavioural
Behavioral text messages about heart failure self-care
MyAppsBehavioural
consumer mobile health apps and devices for heart failure self-care
MyApps & Text4HFBehavioural
Consumer mobile health apps and devices supplemented with behavioral text messages for heart failure self-care
Enhanced Usual CareBehavioural
Participants assigned to the enhanced usual care group will receive (1) standard care, (2) patient education about HF self-care, and (3) three connected health devices (Withings weight scale and blood pressure monitor, and Fitbit activity tracker with Fitbit mobile app).
| Study group | Role | What they receive |
|---|---|---|
| Enhanced usual care | Active comparator | Participants assigned to the usual care group will receive (1) standard care, (2) patient education about HF self-care, and (3) three connected health devices. Usual care includes follow-up appointments every 2-3 months with a multidisciplinary team at the outpatient HF clinic. Patient education includes resources about HF self-care from the American Heart Association and Heart Failure Society of America. Connected health devices include the Withings Weight Scale, Withings blood pressure monitor, and Fitbit Charge 6 activity tracker (wrist-based with heart rate sensor). Participants will receive the devices at baseline along with training by research staff on how to use the devices to perform daily self-monitoring of weight, blood pressure, and physical activity/inactivity. The Withings devices have a cellular antenna for automatic transmission of data to our study server (iCardia). Fitbit will be paired with the participant's smartphone. Receives: Behavioral: Enhanced Usual Care |
| Text4HF | Experimental | Participants allocated to the Text4HF group will receive the same components and devices as the usual care group (usual care, patient education, and connected health devices), plus individually tailored Text Messages targeting health beliefs, HF-knowledge, and self-efficacy about HF self-care. Participants will receive 4-6 TMs/week during the induction phase (0 to 3 months), and 2-4 TMs per week during the adoption period (3 to 6 months).Tailoring of the TMs is guided by participants' responses to validated instruments assessing intervention target variables at baseline and 3 months Receives: Behavioral: Text4HF |
| MyApps | Experimental | In addition to usual care and patient education resources, participants in the MyApps group will receive three commercially available apps (Heart Failure Storylines, Withings Health Mate, and Fitbit), and three connected health devices (Withings Body Cardio Scale, Withings BP monitor, and Fitbit activity tracker). The apps interface with the devices via Bluetooth offering patients a comprehensive set of mHealth tools that support the core elements of HF self-care (maintenance, self-monitoring, and self-management). Receives: Behavioral: MyApps |
| MyApps + Text4HF | Experimental | Participants in this group will receive the MyApps and Text4HF intervention components, combined. Receives: Behavioral: MyApps & Text4HF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of days lost due to unplanned cardiovascular hospitalizations or death from any cause
Hospitalization is defined as hospital admission resulting in an overnight stay where the length of stay is at least 24 hours. Events leading to emergency department visit only with a length of stay under 24 hours will not be classified as hospitalization. For a hospitalization to be considered as unplanned the patient must present new symptoms and/or worsening of existing symptoms with the need for immediate admission in a hospital for intensified care. A hospitalization will be considered "cardiovascular" when it is due to cardiovascular causes which includes but is not limited to: HF deterioration, acute myocardial infarction, arrhythmia, HF, pulmonary embolism, cerebrovascular disease (e.g., stroke), severe bleeding, endocarditis, etc.
Measured: 6 months
Secondary outcomes (19)
Percentage of days lost due to unplanned cardiovascular hospitalizations or death from any cause
Hospitalization is defined as hospital admission resulting in an overnight stay where the length of stay is at least 24 hours. Events leading to emergency department visit only with a length of stay under 24 hours will not be classified as hospitalization. For a hospitalization to be considered as unplanned the patient must present new symptoms and/or worsening of existing symptoms with the need for immediate admission in a hospital for intensified care. A hospitalization will be considered "cardiovascular" when it is due to cardiovascular causes which includes but is not limited to: HF deterioration, acute myocardial infarction, arrhythmia, HF, pulmonary embolism, cerebrovascular disease (e.g., stroke), severe bleeding, endocarditis, etc.
Measured: 12 months
Number of patients with unplanned cardiovascular hospitalizations
Number of patients with one or more unplanned cardiovascular-related hospitalizations
Measured: 6 and 12 months
Mean number of unplanned cardiovascular hospitalizations
Mean number of unplanned hospital admissions for cardiovascular reasons
Measured: 6 and 12 months
Unplanned heart failure hospitalizations
Number of patients with one or more hospitalizations due to acute decompensated heart failure
Measured: 6 and 12 months
Mean number of unplanned heart failure hospitalizations
Mean number of unplanned hospital admissions due to acute decompensated heart failure
Measured: 6 and 12 months
Emergency Room visits
Mean number of emergency room visits
Measured: 6 and 12 months
All-cause mortality
Number of deaths from any cause
Measured: 6 and 12 months
Medication adherence - Dose count
Percentage of prescribed number of doses taken. Assessed throughout the study with the AARDEX MEMS Cap Smart Pill Bottle.
Measured: 6 and 12 months
Medication adherence - Dose days
Percentage of days the correct number of doses were taken. Assessed throughout the study with the AARDEX MEMS Cap Smart Pill Bottle.
Measured: 6 and 12 months
Weighing adherence
Percentage of days patients used the Withings smart scale to measure their weight
Measured: 6 and 12 months
Blood pressure monitoring adherence
Percentage of days patients used the Withings smart blood pressure cuff to measure their blood pressure
Measured: 6 and 12 months
Steps
Mean number of steps per day assessed with a Fitbit activity tracker
Measured: 6 and 12 months
Moderate-to-vigorous physical activity (MVPA) minutes
Average number of MVPA minutes per day assessed with a Fitbit activity tracker
Measured: 6 and 12 months
Self-care maintenance
Mean change in self-care maintenance scores from baseline, assessed with the Self-care Heart Failure Index v 7.2. Scores range from 0 to 100. Higher scores indicate better self-care maintenance.
Measured: 3, 6, 9, and 12 months
Symptom perception
Mean change in symptom perception scores from baseline, assessed with the Self-care Heart Failure Index v 7.2. Scores range from 0 to 100. Higher scores indicate better symptom perception.
Measured: 3, 6, 9, and 12 months
Self-care management
Mean change in self-care management scores from baseline, assessed with the Self-care Heart Failure Index v 7.2. Scores range from 0 to 100. Higher scores indicate better self-care management
Measured: 3, 6, 9, and 12 months
Self-care efficacy
Mean change in self-care efficacy scores from baseline, assessed with the Self-care Heart Failure Index v 7.2. Scores range from 0 to 100. Higher scores indicate better self-care efficacy.
Measured: 3, 6, 9, and 12 months
Health Status
Mean change in health status scores from baseline. Health Status will be assessed with the Kansas City Cardiomyopathy Questionnaire, which contains 23-items that can be quantified into five subscales: physical limitations, symptoms (frequency, severity, and change over time), quality of life (QoL), social interference, and self-efficacy. Lower scores indicate worse health status
Measured: 3, 6, 9, and 12 months
Heart Failure Knowledge
Mean change in heart failure knowledge score from baseline. Assessed with the Dutch Heart Failure Knowledge Questionnaire. Higher scores indicate better knowledge.
Measured: 3, 6, 9, and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2024
- Study start4 Oct 2024
- Primary completion31 Mar 2028 (estimated)
- Study completion30 Sep 2028 (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.
- More trials run by University of Illinois ChicagoThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- 2 x 2 factorial randomized controlled trial
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 360 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Illinois Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Spyros Kitsiou, University of Illinois Chicago
- Investigators
- Spyros Kitsiou, PhD, Principal investigator, University of Illinois Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06205225
- Sponsor's protocol ID
- 2022-1592
- Other IDs
- R01HL168376
- Acronym
- iCardia4HF
- Status last verified
- Jan 2026
- First submitted
- 3 Jan 2024
- Last updated
- 30 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- iCardia4HF: A Multi-component mHealth App and Tailored Text-messaging Intervention to Promote Self-care Adherence and Improve Health Outcomes in Patients With Chronic Heart Failure
- ClinicalTrials.gov ID
- NCT06205225
- Acronym / sponsor ID
- iCardia4HF / 2022-1592
- Conditions
- Heart Failure
- Keywords
- mHealth, wearables, mobile apps, heart failure
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 360 participants (estimated)
- Lead sponsor
- University of Illinois ChicagoUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 4 Oct 2024 (actual)
- Primary completion
- 31 Mar 2028 (estimated)
- Study completion
- 30 Sep 2028 (estimated)
- First posted
- 12 Jan 2024 (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.
The goal of this factorial randomized trial is to examine the independent and synergistic efficacies of two mobile health technology interventions in people with chronic heart failure. The first intervention involves the use of multiple consumer mHealth apps and sensor devices (MyApps) for heart failure self-care (maintenance, monitoring, and management). The second intervention is a program of tailored text messages (Text4HF) targeting modifiable behavioral factors associated with heart failure self-care non-adherence. The main questions this study aims to answer are:
- Can the use of consumer mHealth apps and devices (MyApps) improve heart failure self-care and reduce days lost due to cardiovascular hospitalization or death for any cause?
- Can a program of individually tailored text messages (Text4HF) improve heart failure self-care and reduce the days lost due to cardiovascular hospitalization or death for any cause?
- Can MyApps and Text4HF combined lead to greater improvements in heart failure self-care and days lost due to cardiovascular hospitalization or death for any cause
Detailed description
Heart failure (HF) remains one of the most frequent principal diagnoses for hospitalization and a leading cause of death in the United States. Up to 65% of HF readmissions are the result of insufficient self-care. Existing HF self-care interventions delivered face-to-face or via telephone have had limited impact and reach. They require significant provider time and are not always accessible to patients. There is an urgent need for accessible and scalable interventions that are designed to assist patients with HF self-care while in the community to reduce HF readmissions. Consumer mobile health (mHealth) technologies (e.g., mobile apps and sensor devices) hold promise for promoting HF self-care and expanding intervention delivery. However, their efficacy remains largely underexplored.
To address this gap, our team developed a patient-centered HF self-care intervention (iCardia4HF) that combines the use of three consumer mobile health apps and connected health devices (MyApps) with a program of individually tailored text messages (Text4HF) targeting modifiable behavioral factors to promote HF self-care adherence and improve clinical outcomes.
This study aims to conduct a fully powered, 2x2 factorial randomized controlled trial to determine the independent and combined efficacy of the two iCardia4HF intervention components (MyApps and Text4HF) at 6 months, as well as their maintenance efficacy at 6 months post-intervention. A total of 360 patients with HF will be recruited and randomized to one of four conditions for 12 months: (1) Usual care, (2) Text4HF, (3) MyApps, or (4) MyApps\&Text4HF. Specific aims are:
Aim 1: Determine the independent and combined efficacies of MyApps and Text4HF at 6-months on the primary outcome of days lost due to cardiovascular hospitalization or death for any cause, and secondary outcomes of HF self-care and health status.
Hypothesis 1a: MyApps and Text4HF will have significant main effects on the primary outcome at 6 months.
Hypothesis 1b: MyApps and Text4HF will have significant main effects on objectively assessed measures of HF self-care adherence, self-reported HF self-care, and health status, at 6 months.
Aim 2: Determine the independent and combined maintenance efficacies of MyApps and Text4HF at 12 months (6 months post-intervention).
Hypothesis 2a: Text4HF and MyApps will have significant main effects on the primary outcome at 12 months.
Hypothesis 2b: Text4HF and MyApps will have significant main effects on objectively assessed measures of HF self-care adherence, self-reported HF self-care, and health status, at 12 months.
Aim 3: Investigate the mediating effect of intervention targets (health beliefs, HF knowledge, self-efficacy), and moderating effect of multi-level determinants of HF self-care adherence on the efficacy of the intervention, across individual (e.g., age, race/ethnicity), illness-related (e.g., depression, comorbidities), and socioeconomic factors (e.g., insurance, income, employment, and access to care).
Impact statement: This study will provide important new knowledge that will critically shape our understanding about the potential of commercially available mHealth technologies and tailored text messages to improve HF self-care adherence and reduce hospital readmissions in patients with HF.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 4
- Model description
- 2 x 2 factorial randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Enhanced usual care | Active comparator | Behavioral: Enhanced Usual CareParticipants assigned to the usual care group will receive (1) standard care, (2) patient education about HF self-care, and (3) three connected health devices. Usual care includes follow-up appointments every 2-3 months with a multidisciplinary team at the outpatient HF clinic. Patient education includes resources about HF self-care from the American Heart Association and Heart Failure Society of America. Connected health devices include the Withings Weight Scale, Withings blood pressure monitor, and Fitbit Charge 6 activity tracker (wrist-based with heart rate sensor). Participants will receive the devices at baseline along with training by research staff on how to use the devices to perform daily self-monitoring of weight, blood pressure, and physical activity/inactivity. The Withings devices have a cellular antenna for automatic transmission of data to our study server (iCardia). Fitbit will be paired with the participant's smartphone. |
| Text4HF | Experimental | Behavioral: Text4HFParticipants allocated to the Text4HF group will receive the same components and devices as the usual care group (usual care, patient education, and connected health devices), plus individually tailored Text Messages targeting health beliefs, HF-knowledge, and self-efficacy about HF self-care. Participants will receive 4-6 TMs/week during the induction phase (0 to 3 months), and 2-4 TMs per week during the adoption period (3 to 6 months).Tailoring of the TMs is guided by participants' responses to validated instruments assessing intervention target variables at baseline and 3 months |
| MyApps | Experimental | Behavioral: MyAppsIn addition to usual care and patient education resources, participants in the MyApps group will receive three commercially available apps (Heart Failure Storylines, Withings Health Mate, and Fitbit), and three connected health devices (Withings Body Cardio Scale, Withings BP monitor, and Fitbit activity tracker). The apps interface with the devices via Bluetooth offering patients a comprehensive set of mHealth tools that support the core elements of HF self-care (maintenance, self-monitoring, and self-management). |
| MyApps + Text4HF | Experimental | Behavioral: MyApps & Text4HFParticipants in this group will receive the MyApps and Text4HF intervention components, combined. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Diagnosis of Stage C Heart Failure
- ≥ 18 years of age
- Transthoracic Echocardiogram or Cardiac MRI performed in the last 3 years and LVEF results available
- Patient is actively treated with oral loop diuretics for chronic heart failure
- Hospitalization due to acute decompensated heart failure within 24 months before randomization and/or insufficient self-care per SCHFI assessment (score of ≤3, in at least two items of the SCHFI v7.2 maintenance, symptom monitoring, or self-care management subscale)
Key exclusion criteria (18 listed)
- Implanted ventricular assist device
- High urgent listed for heart transplantation
- Acute coronary syndrome within the last 7 days before randomization
- Revascularization and/or CRT implantation within 28 days before randomization
- Planned revascularization, transcatheter aortic valve implantation, MitraClip and/or CRT implantation within 3 months after randomization
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 |
|---|---|---|
| Text4HFBehavioral text messages about heart failure self-care | Behavioural | Text4HF |
| MyAppsconsumer mobile health apps and devices for heart failure self-care | Behavioural | MyApps |
| MyApps & Text4HFConsumer mobile health apps and devices supplemented with behavioral text messages for heart failure self-care | Behavioural | MyApps + Text4HF |
| Enhanced Usual CareParticipants assigned to the enhanced usual care group will receive (1) standard care, (2) patient education about HF self-care, and (3) three connected health devices (Withings weight scale and blood pressure monitor, and Fitbit activity tracker with Fitbit mobile app). | Behavioural | Enhanced usual care |
Primary outcome
Percentage of days lost due to unplanned cardiovascular hospitalizations or death from any cause
Time frame: 6 months
Hospitalization is defined as hospital admission resulting in an overnight stay where the length of stay is at least 24 hours. Events leading to emergency department visit only with a length of stay under 24 hours will not be classified as hospitalization. For a hospitalization to be considered as unplanned the patient must present new symptoms and/or worsening of existing symptoms with the need for immediate admission in a hospital for intensified care. A hospitalization will be considered "cardiovascular" when it is due to cardiovascular causes which includes but is not limited to: HF deterioration, acute myocardial infarction, arrhythmia, HF, pulmonary embolism, cerebrovascular disease (e.g., stroke), severe bleeding, endocarditis, etc.
19 secondary outcomes
Percentage of days lost due to unplanned cardiovascular hospitalizations or death from any cause
Time frame: 12 months
Number of patients with unplanned cardiovascular hospitalizations
Time frame: 6 and 12 months
Mean number of unplanned cardiovascular hospitalizations
Time frame: 6 and 12 months
Unplanned heart failure hospitalizations
Time frame: 6 and 12 months
Mean number of unplanned heart failure hospitalizations
Time frame: 6 and 12 months
Emergency Room visits
Time frame: 6 and 12 months
All-cause mortality
Time frame: 6 and 12 months
Medication adherence - Dose count
Time frame: 6 and 12 months
Medication adherence - Dose days
Time frame: 6 and 12 months
Weighing adherence
Time frame: 6 and 12 months
Blood pressure monitoring adherence
Time frame: 6 and 12 months
Steps
Time frame: 6 and 12 months
Moderate-to-vigorous physical activity (MVPA) minutes
Time frame: 6 and 12 months
Self-care maintenance
Time frame: 3, 6, 9, and 12 months
Symptom perception
Time frame: 3, 6, 9, and 12 months
Self-care management
Time frame: 3, 6, 9, and 12 months
Self-care efficacy
Time frame: 3, 6, 9, and 12 months
Health Status
Time frame: 3, 6, 9, and 12 months
Heart Failure Knowledge
Time frame: 3, 6, 9, and 12 months
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 30 Jan 2026.
- Individual participant dataSharing planned: No
Related trials for Heart Failure
RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF)
Heart Failure With Reduced Ejection Fraction, Iron Deficiency
Not yet recruitingPhase 2
A Study of Bimagrumab in Participants With HFpEF
Heart Failure, Diastolic, Diastolic Heart Failure
Recruiting
Evaluation of a French Hospital Discharge Therapeutic Education Program by Nurses for Heart Failure Patient (EduSor)
Heart Failure
Active, not recruiting
Assessment of Combined CCM and ICD Device in HFrEF
Heart Failure, Heart Failure With Reduced Ejection Fraction
Not yet recruiting
RELIEVE-HFrEF TRIAL: REducing Lung congestIon Symptoms Using the v-wavE Shunt in adVancEd Heart Failure With Reduced EF
Heart Failure and Reduced Ejection Fraction, Heart Failure Chronic
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.
Spyros Kitsiou, PhD principal investigator
University of Illinois Chicago
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Text4HF, MyApps and MyApps & Text4HF in people with Heart Failure, run by University of Illinois Chicago at 2 sites in United States.
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 18 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: looking for participants now, as of the sponsor's last update on 30 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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 Spyros Kitsiou, PhD (312-413-4227, mhanif6@uic.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of days lost due to unplanned cardiovascular hospitalizations or death from any cause (time frame: 6 months). 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 30 Jan 2026.