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

NCT ID: NCT04262544

Last Updated: 2023-04-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 89 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-02-20
• Study Completion Date: 2022-12-31

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.

Conditions

Heart Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

mHealth

Intervention group

Group Type: EXPERIMENTAL

iCardia4HF

Intervention Type: BEHAVIORAL

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.

Usual Care

Control group

Group Type: ACTIVE_COMPARATOR

Usual Care

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: BEHAVIORAL

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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Nursing Research (NINR)

NIH

Sponsor Role: collaborator

Indiana University

OTHER

Sponsor Role: collaborator

Rush University Medical Center

OTHER

Sponsor Role: collaborator

University of Illinois at Chicago

OTHER

Sponsor Role: lead

Responsible Party

Spyros Kitsiou

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Spyros Kitsiou

Role: PRINCIPAL_INVESTIGATOR

University of Illinois at Chicago

Locations

University of Illinois Hospital & Health Sciences System

Chicago, Illinois, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 33991686 (View on PubMed)

Other Identifiers

1R21NR018281-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2019-0790

Identifier Type: -

Identifier Source: org_study_id