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| ID | Type | Description | Link |
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| R01HL168376 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
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| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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 |
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| 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). |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Text4HF | Behavioral | Behavioral text messages about heart failure self-care |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Spyros Kitsiou, PhD | Contact | 312-413-4227 | mhanif6@uic.edu |
| Name | Affiliation | Role |
|---|---|---|
| Spyros Kitsiou, PhD | University of Illinois at Chicago | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
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| Rush University Medical Center | Recruiting | Chicago | Illinois | 60612 | United States |
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| ID | Term |
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| D006333 | Heart Failure |
| ID | Term |
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| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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2 x 2 factorial randomized controlled trial
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Care providers who provide usual care to study participants will be unaware of the study groups and group assignments. Outcome assessors will be masked to group assignment. Outcome assessors will work in a different office from other study investigators and will have limited access to the Electronic Data Capturing system used for data collection (REDCap).
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| MyApps + Text4HF | Experimental | Participants in this group will receive the MyApps and Text4HF intervention components, combined. |
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| MyApps |
| Behavioral |
consumer mobile health apps and devices for heart failure self-care |
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| MyApps & Text4HF | Behavioral | Consumer mobile health apps and devices supplemented with behavioral text messages for heart failure self-care |
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| Enhanced Usual Care | Behavioral | 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). |
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| 12 months |
| Number of patients with unplanned cardiovascular hospitalizations | Number of patients with one or more unplanned cardiovascular-related hospitalizations | 6 and 12 months |
| Mean number of unplanned cardiovascular hospitalizations | Mean number of unplanned hospital admissions for cardiovascular reasons | 6 and 12 months |
| Unplanned heart failure hospitalizations | Number of patients with one or more hospitalizations due to acute decompensated heart failure | 6 and 12 months |
| Mean number of unplanned heart failure hospitalizations | Mean number of unplanned hospital admissions due to acute decompensated heart failure | 6 and 12 months |
| Emergency Room visits | Mean number of emergency room visits | 6 and 12 months |
| All-cause mortality | Number of deaths from any cause | 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. | 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. | 6 and 12 months |
| Weighing adherence | Percentage of days patients used the Withings smart scale to measure their weight | 6 and 12 months |
| Blood pressure monitoring adherence | Percentage of days patients used the Withings smart blood pressure cuff to measure their blood pressure | 6 and 12 months |
| Steps | Mean number of steps per day assessed with a Fitbit activity tracker | 6 and 12 months |
| Moderate-to-vigorous physical activity (MVPA) minutes | Average number of MVPA minutes per day assessed with a Fitbit activity tracker | 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. | 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. | 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 | 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. | 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 | 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. | 3, 6, 9, and 12 months |
| University of Illinois Hospital & Health Sciences System | Recruiting | Chicago | Illinois | 60612 | United States |
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