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

Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04262544
• Other study ID #: 2019-0790
• Secondary ID: 1R21NR018281-01A
• Status: Completed
• Phase: N/A
• Start date: February 20, 2020
• Est. completion date: December 31, 2022

Study information

• Verified date: April 2023
• Source: University of Illinois at Chicago
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 89
• Est. completion date: December 31, 2022
• Est. primary completion date: September 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure

Intervention

Behavioral:
• iCardia4HF
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.

Other:
• Usual Care
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.

Locations

Country	Name	City	State
United States	University of Illinois Hospital & Health Sciences System	Chicago	Illinois

Sponsors (4)

Lead Sponsor	Collaborator
University of Illinois at Chicago	Indiana University, National Institute of Nursing Research (NINR), Rush University Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	HF-related hospitalizations	Number of patients with an event	Weeks 1 to 12
Other	HF-related hospitalization rate	Number of hospitalizations per person	Weeks 1 to 12
Other	All-cause hospitalizations	Number of patients with an event	Weeks 1 to 12
Other	All-cause hospitalization rate	Number of all-cause hospitalizations per person	Weeks 1 to 12
Other	Emergency room visits	Number of patients with an event	Weeks 1 to 12
Other	Emergency room visit rate	Number of emergency room visits per person	Weeks 1 to 12
Primary	Medication adherence (dose count)	Percent of prescribed number of doses taken	Weeks 1 to 12
Primary	Medication adherence (dose time)	Percent of doses taken on schedule within 25% of the expected time interval	Weeks 1 to 12
Primary	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	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
Secondary	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
Secondary	Physical activity - Steps	Number of daily steps (measured with a Fitbit device)	Weeks 1 to 12
Secondary	Moderate-to-Vigorous Physical Activity	Number of moderate-to-vigorous physical activity minutes per day (measured with a Fitbit device)	Weeks 1 to 12
Secondary	Adherence to low-sodium diet	Sodium intake will be assessed with a urinary sample test	Baseline, 12 Weeks
Secondary	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
Secondary	Health Beliefs about Medication Compliance	Beliefs about Medication Compliance Scale (12-items)	Baseline, 30 days, and 12 Weeks
Secondary	Health Beliefs about Dietary Compliance	Beliefs about Dietary Compliance Scale (12 items)	Baseline, 30 days, and 12 Weeks
Secondary	Health Beliefs about Self-Monitoring Compliance	Beliefs about Self-Monitoring Scale (18 items)	Baseline, 30 days, and 12 Weeks
Secondary	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
Secondary	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