- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04262544
An Innovative Mobile Health Intervention to Improve Self-care in Patients With Heart Failure
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
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Illinois
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Chicago, Illinois, United States, 60612
- University of Illinois Hospital & Health Sciences System
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: mHealth
Intervention group
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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.
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Active Comparator: Usual Care
Control group
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Medication adherence (dose count)
Time Frame: Weeks 1 to 12
|
Percent of prescribed number of doses taken
|
Weeks 1 to 12
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Medication adherence (dose time)
Time Frame: Weeks 1 to 12
|
Percent of doses taken on schedule within 25% of the expected time interval
|
Weeks 1 to 12
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Adherence to daily self-monitoring of weight
Time Frame: Weeks 1 to 12
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Number of days patients completed at least one measurement between 12 am and 11:59pm
|
Weeks 1 to 12
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Adherence to daily self-monitoring of blood pressure
Time Frame: Weeks 1 to 12
|
Number of days patients completed at least one BP measurement between 12 am and 11:59pm
|
Weeks 1 to 12
|
Adherence to self-monitoring of HF symptoms
Time Frame: Weeks 1 to 12
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Number of days intervention patients used the mobile app to record their HF symptoms
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Weeks 1 to 12
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Physical activity - Steps
Time Frame: Weeks 1 to 12
|
Number of daily steps (measured with a Fitbit device)
|
Weeks 1 to 12
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Moderate-to-Vigorous Physical Activity
Time Frame: Weeks 1 to 12
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Number of moderate-to-vigorous physical activity minutes per day (measured with a Fitbit device)
|
Weeks 1 to 12
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Adherence to low-sodium diet
Time Frame: Baseline, 12 Weeks
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Sodium intake will be assessed with a urinary sample test
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Baseline, 12 Weeks
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Self-reported Self-care
Time Frame: Baseline, 30 days, and 12 Weeks
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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.
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Baseline, 30 days, and 12 Weeks
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Health Beliefs about Medication Compliance
Time Frame: Baseline, 30 days, and 12 Weeks
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Beliefs about Medication Compliance Scale (12-items)
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Baseline, 30 days, and 12 Weeks
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Health Beliefs about Dietary Compliance
Time Frame: Baseline, 30 days, and 12 Weeks
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Beliefs about Dietary Compliance Scale (12 items)
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Baseline, 30 days, and 12 Weeks
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Health Beliefs about Self-Monitoring Compliance
Time Frame: Baseline, 30 days, and 12 Weeks
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Beliefs about Self-Monitoring Scale (18 items)
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Baseline, 30 days, and 12 Weeks
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HF-knowledge
Time Frame: Baseline, 30 days, and 12 Weeks
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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)
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Baseline, 30 days, and 12 Weeks
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Health-related Quality of life (HRQoL)
Time Frame: Baseline, 30 days, and 12 Weeks
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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.
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Baseline, 30 days, and 12 Weeks
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
HF-related hospitalizations
Time Frame: Weeks 1 to 12
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Number of patients with an event
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Weeks 1 to 12
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HF-related hospitalization rate
Time Frame: Weeks 1 to 12
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Number of hospitalizations per person
|
Weeks 1 to 12
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All-cause hospitalizations
Time Frame: Weeks 1 to 12
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Number of patients with an event
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Weeks 1 to 12
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All-cause hospitalization rate
Time Frame: Weeks 1 to 12
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Number of all-cause hospitalizations per person
|
Weeks 1 to 12
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Emergency room visits
Time Frame: Weeks 1 to 12
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Number of patients with an event
|
Weeks 1 to 12
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Emergency room visit rate
Time Frame: Weeks 1 to 12
|
Number of emergency room visits per person
|
Weeks 1 to 12
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Spyros Kitsiou, University of Illinois at Chicago
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2019-0790
- 1R21NR018281-01A1 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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