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OpenTrials
Completed

NCT Number: NCT03642275

Patient-centered Mobile Health Intervention to Improve Self-care in Patients With Chronic Heart Failure

Approximately 6.5 million people have heart failure (HF) in the United States, and 960,000 new cases are reported each year. HF is one of the most common hospital diagnosis among older adults. About 40% of patients are readmitted within 1-year following their first admission for HF and hospitalization accounts for approximately 80% of the costs of HF management. This pilot study aims to assess the feasibility, acceptability, and preliminary efficacy of a patient-centered mobile health (mHealth) technology intervention in older adults with chronic heart failure.

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Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Illinois Hospital & Health Sciences System

Chicago, Illinois, 60612, United States

About this study

This is a single site, two-arm, pilot randomized controlled trial that aims to examine the feasibility, acceptability and preliminary efficacy of a mobile phone-based intervention compared to usual care in older adult patients with HF (≥50 years). Forty (n=40) patients from the University of Illinois Hospital & Health Sciences system will be enrolled in the study, randomly assigned to the intervention or usual care group, and followed for 60 days. Patients in the intervention group will receive the Heart Failure Health Storylines mobile app developed by Self Care Catalysts in collaboration with the Heart Failure Society of America, three connected health devices from Fitbit and Nokia that interface with the mobile app, and tailored text-messages targeting health beliefs, self-care efficacy, and knowledge about HF. The control group will receive standard care which involves patient education and outpatient follow up with physical and laboratory examinations as needed. The primary study outcome is change in self-care and quality of life. Secondary outcomes include hospital re-admissions and emergency room visits.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Inpatients or outpatients with a diagnosis of HF as defined by the International Classification of Diseases (ICD-10) codes
  • Stage C, NYHA I, II or III
  • ≥ 40 years of age
  • Own a smartphone with text-messaging and internet plan
  • Ability to speak and read English
  • Live within 30 miles from UI Health

Exclusion criteria

  • On an active waiting list for implanted ventricular assist device or heart transplant
  • Advanced renal disease (dialysis or creatinine >4.0mg/dL)
  • End-stage HF (hospice candidate)
  • Active cancer
  • Individuals who are not their own primary caregiver
  • Discharge to a setting other than home
  • Patients with baseline Montreal Cognitive Assessment (MoCA) score of < 22

Treatment and study plan

iCardia4HF

Behavioral

Participants in the intervention group will receive the Heart Failure Health Storylines mobile app, three connected health devices that interface with the app (Fitbit Charge 2 activity tracker, and FDA-approved Nokia BP monitor and Cardio Body weight scale), and a program of tailored self-care text-messages, in addition to usual care. Participants will be asked to use the app and devices to record and self-monitor their daily symptoms, blood pressure, weight, and physical activity.

Primary outcomes

  1. Change from Baseline in Self-care at 30 and 60 days

    Time frame: Baseline, 30 and 60 days

    Self-care will be measured with the Self-Care Heart Failure Index (SCHFI) v.6.2,87 which includes 3 subscales: self-care maintenance (10-items), self-care confidence (6-items), and self-care management (6-items). Standardized scores in each scale range from 0 to 100. A total score of ≥70 indicates adequate self-care.

  2. Change from Baseline in Health-related Quality of Life (HRQoL) at 30 and 60 days

    Time frame: Baseline, 30 and 60 days

    HRQoL will be measured with the Kansas City Cardiomyopathy Questionnaire (23-items) that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life. Lower scores indicate worse HRQoL.

Secondary outcomes

  1. Hospitalizations

    Time frame: 60 days

    The number of hospitalizations during the study will be measured with both self-report and the electronic medical record.

  2. ER visits

    Time frame: 60 days

    The number of emergency room visits will be collected based on both self-reports and the electronic medical record

Sponsors and collaborators

Lead sponsor

University of Illinois at Chicago

Other

Registry information

Official study title

iCardia4HF: A Patient-centered Mobile Health Intervention to Promote Self-care and Improve Patient Outcomes in Chronic Heart Failure

Acronym: iCardia4HF

Important dates

Study start
2019
Primary completion
2020
Study completion
2021
First posted
Aug 22, 2018
Registry last updated
Apr 9, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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