Heart FailureNCT04262544
An Innovative Mobile Health Intervention to Improve Self-care in Patients With Heart Failure
A study testing iCardia4HF in people with Heart Failure, run by University of Illinois Chicago at 1 site in United States.
Trial summary
Heart failure (HF) is associated with high mortality and hospitalization rates. Prior studies show that adherence to routine HF self-care behaviors reduces the risk of all-cause mortality and HF-related hospitalizations, and improves health related quality of life. 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?
- iCardia4HF
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 89 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Feb 2020to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Chronic HF, Stage C
- ≥ 18 years of age
- Being treated with oral diuretics for heart failure
- Suboptimal HF self-care adherence (score 1 or 2 in at least two items of the Self-care of Heart Failure Index v.7.2)
- Ability to speak and read English
Who cannot join
- Planned coronary revascularization, Transcatheter Aortic Valve Implantation (TAVI), Cardiac Resynchronization Therapy (CRT) - implantation, and/or heart transplantation (HTx) within the next 3 months.
- Coronary revascularization and/or CRT-implantation within the last 30 days
- Advanced renal disease (stage IV CKD, GFR<30, or hemodialysis)
- Known alcohol or drug use
- End-stage HF (hospice candidate)
- Active cancer
Show all 11Show fewer
- Pregnancy
- Not able to take care of self (eat, dress, walk, bath, take medications, or use the toilet)
- Discharged to or already living in a nursing home or other care facility other than home
- Cognitive impairment (MoCA score < 22).
- Prior use of study devices for self-care or participation in a similar trial
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Illinois Hospital & Health Sciences System
Chicago, Illinois, 60612
About this study
Heart failure (HF) is associated with high mortality and hospitalization rates. Prior studies show that adherence to routine HF self-care behaviors reduces the risk of all-cause mortality and HF-related hospitalizations, and improves health related quality of life. However, self-care has generally been found to be poor among HF patients. This study aims to assess the feasibility, acceptance, and efficacy of an innovative, patient-centered intervention (iCardia4HF) that aims to promote adherence to HF self-care and improve patient outcomes through the use of commercially available mobile health technologies.
Read the detailed description
More than 6.5 million people have heart failure (HF) in the United States and 960,000 new cases are reported annually. HF is associated with high mortality and hospitalization rates, high costs, and poor health-related quality of life (HRQL). Despite major improvements in outcomes with medical and surgical therapy, admission rates following a HF-related hospitalization remain high with 25% of patients readmitted to the hospital within 30-days and up to 50% readmitted within 6 months. Previous research shows that adherence to routine HF self-care behaviors reduces the risk of all-cause mortality and HF-related hospitalization, and improves HRQL. However, self-care has generally been found to be poor among HF patients, particularly minority populations. Nonadherence to HF symptom monitoring and medication use is remarkably high even among recently discharged patients hospitalized due to a HF exacerbation. Recent advances in consumer-based mobile health (mHealth) technologies, such as smartphones, mobile health apps, wearable sensors, and other smart and connected health devices, offer scalable and affordable solutions for promoting better HF self-care and expanding delivery of care services to communities that are difficult to reach. However, no prior studies have assessed the impact of these technologies on HF self-care and patient outcomes.
This study aims to conduct a pilot randomized controlled trial (RCT) of a patient-centered intervention named iCardia4HF that promotes adherence to HF self-care through the use of commercial mHealth devices and app tools. iCardia4HF consists of: (1) a patient-centered mHealth app, developed in partnership with the Heart Failure Society of America, that interfaces with multiple connected health devices and comprises a number of self- monitoring, patient education, and adherence reminder tools for improving self-care; and (2) individually tailored text-messages (TMs) targeting health beliefs, self-care efficacy, and HF-knowledge. Study participants (n=92) diagnosed with HF will be randomly assigned to iCardia4HF or the control group for 12 weeks. Specific aims are to: 1) assess the feasibility and acceptance of iCardia4HF; 2) examine the preliminary efficacy of iCardia4HF on objectively assessed measures of HF self-care using real- time data from the connected health devices and app, as well as self-reported Self-Care and HRQL; track the number of hospitalizations and emergency room (ER) visits over 12 weeks; and 3) examine the mediating effect of intervention target variables (health beliefs, self-care efficacy, and HF-knowledge) and impact of independent patient factors on HF self-care.
This study represents an important step in identifying an affordable and scalable mHealth intervention that has the potential to bring about a new paradigm in self-care management of HF.
- Conditions
- Heart Failure
- Being tested
- iCardia4HF, Usual Care
- Keywords
- mHealth, text messaging, smartphone, mobile apps, wearables, heart failure, self-management, telehealth
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iCardia4HFBehavioural
Participants in the intervention group will receive the following main components in addition to usual care: 1) the Heart Failure Health Storylines mobile app which supports daily self-monitoring and management of vital signs and symptoms; 2) three connected health devices (Fitbit activity tracker, Withings Cardio Body weight scale and blood pressure monitor), and 3) a program of tailored text-messages targeting health beliefs, self-efficacy, and HF-knowledge.
Usual CareOther
Participants assigned to the control group will receive usual care and the same connected health devices (Fitbit activity tracker, Withings weight scale and blood pressure monitor) as patients in the intervention group, but without the heart failure health storylines mobile app and text-messaging program. Usual care includes patient education before hospital discharge, and follow-up visits at the outpatient HF clinic a week after discharge and monthly thereafter depending on the patient's condition. Patient education includes literacy-sensitive, education material about HF self-care developed by the Sheps Center for Health Services Research,and a 40-minute education session with an APN and a dietician to review and discuss the education material provided to the patient.
| Study group | Role | What they receive |
|---|---|---|
| mHealth | Experimental | Intervention group Receives: Behavioral: iCardia4HF |
| Usual Care | Active comparator | Control group Receives: Other: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Medication adherence (dose count)
Percent of prescribed number of doses taken
Measured: Weeks 1 to 12
Medication adherence (dose time)
Percent of doses taken on schedule within 25% of the expected time interval
Measured: Weeks 1 to 12
Adherence to daily self-monitoring of weight
Number of days patients completed at least one measurement between 12 am and 11:59pm
Measured: Weeks 1 to 12
Secondary outcomes (11)
Adherence to daily self-monitoring of blood pressure
Number of days patients completed at least one BP measurement between 12 am and 11:59pm
Measured: Weeks 1 to 12
Adherence to self-monitoring of HF symptoms
Number of days intervention patients used the mobile app to record their HF symptoms
Measured: Weeks 1 to 12
Physical activity - Steps
Number of daily steps (measured with a Fitbit device)
Measured: Weeks 1 to 12
Moderate-to-Vigorous Physical Activity
Number of moderate-to-vigorous physical activity minutes per day (measured with a Fitbit device)
Measured: Weeks 1 to 12
Adherence to low-sodium diet
Sodium intake will be assessed with a urinary sample test
Measured: Baseline, 12 Weeks
Self-reported Self-care
Measured with the Self-Care Heart Failure Index (SCHFI) v.7.2. Each scale score ranges from 0 to 100. Higher scores indicate better self-care.
Measured: Baseline, 30 days, and 12 Weeks
Health Beliefs about Medication Compliance
Beliefs about Medication Compliance Scale (12-items)
Measured: Baseline, 30 days, and 12 Weeks
Health Beliefs about Dietary Compliance
Beliefs about Dietary Compliance Scale (12 items)
Measured: Baseline, 30 days, and 12 Weeks
Health Beliefs about Self-Monitoring Compliance
Beliefs about Self-Monitoring Scale (18 items)
Measured: Baseline, 30 days, and 12 Weeks
HF-knowledge
HF-specific knowledge will be assessed with the Dutch Heart Failure Knowledge Scale (DHFK), a 15-item questionnaire measuring general knowledge about HF, symptom recognition, and treatment (e.g. diet and fluid restriction)
Measured: Baseline, 30 days, and 12 Weeks
Health-related Quality of life (HRQoL)
HRQoL will be measured 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 HRQoL.
Measured: Baseline, 30 days, and 12 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2020
- Study start20 Feb 2020
- Primary completion30 Sep 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Illinois Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR), Indiana University, Rush University Medical Center
- Responsible party
- Principal investigator, Spyros Kitsiou, University of Illinois Chicago
- Investigators
- Spyros Kitsiou, Principal investigator, University of Illinois Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04262544
- Sponsor's protocol ID
- 2019-0790
- Other IDs
- 1R21NR018281-01A1
- Status last verified
- Apr 2023
- First submitted
- 6 Jan 2020
- Last updated
- 28 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Final research data along with metadata and descriptors will be shared to make sharing meaningful and usable by other researchers. More specifically, we will share both de-identified individual-level data and aggregate data in the form of summary statistics and tables. For the individual-level data, we will develop a data dictionary and documentation guide to maximize the utility of the data and to help qualified researchers understand and properly use the data as needed.
Publications
Kitsiou S, Gerber BS, Kansal MM, Buchholz SW, Chen J, Ruppar T, Arrington J, Owoyemi A, Leigh J, Pressler SJ. Patient-centered mobile health technology intervention to improve self-care in patients with chronic heart failure: Protocol for a feasibility randomized controlled trial. Contemp Clin Trials. 2021 Jul;106:106433. doi: 10.1016/j.cct.2021.106433. Epub 2021 May 13.
PubMed 33991686
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Innovative Mobile Health Intervention to Improve Self-care in Patients With Heart Failure
- ClinicalTrials.gov ID
- NCT04262544
- Acronym / sponsor ID
- 2019-0790
- Conditions
- Heart Failure
- Keywords
- mHealth, text messaging, smartphone, mobile apps, wearables, heart failure, self-management, telehealth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- University of Illinois ChicagoUniversity, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR), Indiana University, Rush University Medical Center
- Study start
- 20 Feb 2020 (actual)
- Primary completion
- 30 Sep 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 10 Feb 2020 (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.
Heart failure (HF) is associated with high mortality and hospitalization rates. Prior studies show that adherence to routine HF self-care behaviors reduces the risk of all-cause mortality and HF-related hospitalizations, and improves health related quality of life. However, self-care has generally been found to be poor among HF patients. This study aims to assess the feasibility, acceptance, and efficacy of an innovative, patient-centered intervention (iCardia4HF) that aims to promote adherence to HF self-care and improve patient outcomes through the use of commercially available mobile health technologies.
Detailed description
More than 6.5 million people have heart failure (HF) in the United States and 960,000 new cases are reported annually. HF is associated with high mortality and hospitalization rates, high costs, and poor health-related quality of life (HRQL). Despite major improvements in outcomes with medical and surgical therapy, admission rates following a HF-related hospitalization remain high with 25% of patients readmitted to the hospital within 30-days and up to 50% readmitted within 6 months. Previous research shows that adherence to routine HF self-care behaviors reduces the risk of all-cause mortality and HF-related hospitalization, and improves HRQL. However, self-care has generally been found to be poor among HF patients, particularly minority populations. Nonadherence to HF symptom monitoring and medication use is remarkably high even among recently discharged patients hospitalized due to a HF exacerbation. Recent advances in consumer-based mobile health (mHealth) technologies, such as smartphones, mobile health apps, wearable sensors, and other smart and connected health devices, offer scalable and affordable solutions for promoting better HF self-care and expanding delivery of care services to communities that are difficult to reach. However, no prior studies have assessed the impact of these technologies on HF self-care and patient outcomes.
This study aims to conduct a pilot randomized controlled trial (RCT) of a patient-centered intervention named iCardia4HF that promotes adherence to HF self-care through the use of commercial mHealth devices and app tools. iCardia4HF consists of: (1) a patient-centered mHealth app, developed in partnership with the Heart Failure Society of America, that interfaces with multiple connected health devices and comprises a number of self- monitoring, patient education, and adherence reminder tools for improving self-care; and (2) individually tailored text-messages (TMs) targeting health beliefs, self-care efficacy, and HF-knowledge. Study participants (n=92) diagnosed with HF will be randomly assigned to iCardia4HF or the control group for 12 weeks. Specific aims are to: 1) assess the feasibility and acceptance of iCardia4HF; 2) examine the preliminary efficacy of iCardia4HF on objectively assessed measures of HF self-care using real- time data from the connected health devices and app, as well as self-reported Self-Care and HRQL; track the number of hospitalizations and emergency room (ER) visits over 12 weeks; and 3) examine the mediating effect of intervention target variables (health beliefs, self-care efficacy, and HF-knowledge) and impact of independent patient factors on HF self-care.
This study represents an important step in identifying an affordable and scalable mHealth intervention that has the potential to bring about a new paradigm in self-care management of HF.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| mHealth | Experimental | Behavioral: iCardia4HFIntervention group |
| Usual Care | Active comparator | Other: Usual CareControl group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Chronic HF, Stage C
- ≥ 18 years of age
- Being treated with oral diuretics for heart failure
- Suboptimal HF self-care adherence (score 1 or 2 in at least two items of the Self-care of Heart Failure Index v.7.2)
- Ability to speak and read English
Key exclusion criteria (11 listed)
- Planned coronary revascularization, Transcatheter Aortic Valve Implantation (TAVI), Cardiac Resynchronization Therapy (CRT) - implantation, and/or heart transplantation (HTx) within the next 3 months.
- Coronary revascularization and/or CRT-implantation within the last 30 days
- Advanced renal disease (stage IV CKD, GFR<30, or hemodialysis)
- Known alcohol or drug use
- End-stage HF (hospice candidate)
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 |
|---|---|---|
| iCardia4HFParticipants in the intervention group will receive the following main components in addition to usual care: 1) the Heart Failure Health Storylines mobile app which supports daily self-monitoring and management of vital signs and symptoms; 2) three connected health devices (Fitbit activity tracker, Withings Cardio Body weight scale and blood pressure monitor), and 3) a program of tailored text-messages targeting health beliefs, self-efficacy, and HF-knowledge. | Behavioural | mHealth |
| Usual CareParticipants assigned to the control group will receive usual care and the same connected health devices (Fitbit activity tracker, Withings weight scale and blood pressure monitor) as patients in the intervention group, but without the heart failure health storylines mobile app and text-messaging program. Usual care includes patient education before hospital discharge, and follow-up visits at the outpatient HF clinic a week after discharge and monthly thereafter depending on the patient's condition. Patient education includes literacy-sensitive, education material about HF self-care developed by the Sheps Center for Health Services Research,and a 40-minute education session with an APN and a dietician to review and discuss the education material provided to the patient. | Other | Usual Care |
Primary outcome
Medication adherence (dose count)
Time frame: Weeks 1 to 12
Percent of prescribed number of doses taken
Medication adherence (dose time)
Time frame: Weeks 1 to 12
Percent of doses taken on schedule within 25% of the expected time interval
Adherence to daily self-monitoring of weight
Time frame: Weeks 1 to 12
Number of days patients completed at least one measurement between 12 am and 11:59pm
11 secondary outcomes
Adherence to daily self-monitoring of blood pressure
Time frame: Weeks 1 to 12
Adherence to self-monitoring of HF symptoms
Time frame: Weeks 1 to 12
Physical activity - Steps
Time frame: Weeks 1 to 12
Moderate-to-Vigorous Physical Activity
Time frame: Weeks 1 to 12
Adherence to low-sodium diet
Time frame: Baseline, 12 Weeks
Self-reported Self-care
Time frame: Baseline, 30 days, and 12 Weeks
Health Beliefs about Medication Compliance
Time frame: Baseline, 30 days, and 12 Weeks
Health Beliefs about Dietary Compliance
Time frame: Baseline, 30 days, and 12 Weeks
Health Beliefs about Self-Monitoring Compliance
Time frame: Baseline, 30 days, and 12 Weeks
HF-knowledge
Time frame: Baseline, 30 days, and 12 Weeks
Health-related Quality of life (HRQoL)
Time frame: Baseline, 30 days, and 12 Weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2023.
- Derived from this study: PubMed 33991686Kitsiou S, Gerber BS, Kansal MM, Buchholz SW, Chen J, Ruppar T, Arrington J, Owoyemi A, Leigh J, Pressler SJ. Patient-centered mobile health technology intervention to improve self-care in patients with chronic heart failure: Protocol for a feasibility randomized controlled trial. Contemp Clin Trials. 2021 Jul;106:106433. doi: 10.1016/j.cct.2021.106433. Epub 2021 May 13.
- Individual participant dataSharing planned: Yes. Final research data along with metadata and descriptors will be shared to make sharing meaningful and usable by other researchers. More specifically, we will share both de-identified individual-level data and aggregate data in the form of summary statistics and tables. For the individual-level data, we will develop a data dictionary and documentation guide to maximize the utility of the data and to help qualified researchers understand and properly use the data as needed.
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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. This study is not recruiting at the moment.
Spyros Kitsiou principal investigator
University of Illinois Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing iCardia4HF in people with Heart Failure, run by University of Illinois Chicago at 1 site 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 5 inclusion and 11 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: finished, as of the sponsor's last update on 28 Apr 2023. 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 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Medication adherence (dose count) (time frame: Weeks 1 to 12). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04262544, which also lists 1 linked publication.
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 28 Apr 2023.