An Innovative Mobile Health Intervention to Improve Self-care in Patients With Heart Failure

Study Overview
=================
Brief 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. 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.

Official Title
-----------------
An Innovative Mobile Health Intervention to Improve Self-care in Patients With Heart Failure

Conditions
-----------------
Heart Failure

Intervention / Treatment
-----------------
* Behavioral: iCardia4HF
* Other: Usual Care


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: mHealth<br>Intervention group | Behavioral: iCardia4HF<br>* 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.<br>|
| Active Comparator: Usual Care<br>Control group | Other: Usual Care<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Medication adherence (dose count) | Percent of prescribed number of doses taken | Weeks 1 to 12 | 
| Medication adherence (dose time) | Percent of doses taken on schedule within 25% of the expected time interval | 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 | Weeks 1 to 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adherence to daily self-monitoring of blood pressure | 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 | Number of days intervention patients used the mobile app to record their HF symptoms | Weeks 1 to 12 | 
| Physical activity - Steps | Number of daily steps (measured with a Fitbit device) | Weeks 1 to 12 | 
| Moderate-to-Vigorous Physical Activity | Number of moderate-to-vigorous physical activity minutes per day (measured with a Fitbit device) | Weeks 1 to 12 | 
| Adherence to low-sodium diet | Sodium intake will be assessed with a urinary sample test | 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. | Baseline, 30 days, and 12 Weeks | 
| Health Beliefs about Medication Compliance | Beliefs about Medication Compliance Scale (12-items) | Baseline, 30 days, and 12 Weeks | 
| Health Beliefs about Dietary Compliance | Beliefs about Dietary Compliance Scale (12 items) | Baseline, 30 days, and 12 Weeks | 
| Health Beliefs about Self-Monitoring Compliance | Beliefs about Self-Monitoring Scale (18 items) | 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) | 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. | Baseline, 30 days, and 12 Weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
mHealth, text messaging, smartphone, mobile apps, wearables, heart failure, self-management, telehealth