Clinical trial NCT04262544: An Innovative Mobile Health Intervention to Improve Self-care in Patients With Heart Failure
Official title: An Innovative Mobile Health Intervention to Improve Self-care in Patients With Heart Failure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Keywords: mHealth
text messaging
smartphone
mobile apps
wearables
heart failure
self-management
telehealth
Lead sponsor: University of Illinois at Chicago
Sponsor class: OTHER
Collaborators: name: National Institute of Nursing Research (NINR)
name: Indiana University
name: Rush University Medical Center
First posted: 2020-02-10
Enrollment: 89
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Medication adherence (dose count)
timeFrame: Weeks 1 to 12
measure: Medication adherence (dose time)
timeFrame: Weeks 1 to 12
measure: Adherence to daily self-monitoring of weight
timeFrame: Weeks 1 to 12
Secondary outcomes:
measure: Adherence to daily self-monitoring of blood pressure
timeFrame: Weeks 1 to 12
measure: Adherence to self-monitoring of HF symptoms
timeFrame: Weeks 1 to 12
measure: Physical activity - Steps
timeFrame: Weeks 1 to 12
measure: Moderate-to-Vigorous Physical Activity
timeFrame: Weeks 1 to 12
measure: Adherence to low-sodium diet
timeFrame: Baseline, 12 Weeks
measure: Self-reported Self-care
timeFrame: Baseline, 30 days, and 12 Weeks
measure: Health Beliefs about Medication Compliance
timeFrame: Baseline, 30 days, and 12 Weeks
measure: Health Beliefs about Dietary Compliance
timeFrame: Baseline, 30 days, and 12 Weeks
measure: Health Beliefs about Self-Monitoring Compliance
timeFrame: Baseline, 30 days, and 12 Weeks
measure: HF-knowledge
timeFrame: Baseline, 30 days, and 12 Weeks
measure: Health-related Quality of life (HRQoL)
timeFrame: Baseline, 30 days, and 12 Weeks
Other outcomes:
measure: HF-related hospitalizations
timeFrame: Weeks 1 to 12
measure: HF-related hospitalization rate
timeFrame: Weeks 1 to 12
measure: All-cause hospitalizations
timeFrame: Weeks 1 to 12
measure: All-cause hospitalization rate
timeFrame: Weeks 1 to 12
measure: Emergency room visits
timeFrame: Weeks 1 to 12
measure: Emergency room visit rate
timeFrame: Weeks 1 to 12
Locations:
city: Chicago
country: United States
facility: University of Illinois Hospital & Health Sciences System
state: Illinois
Study officials:
affiliation: University of Illinois at Chicago
name: Spyros Kitsiou
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.