Patient-centered Mobile Health Intervention to Improve Self-care in Patients With Chronic Heart Failure (iCardia4HF)
Primary Purpose
Heart Failure
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
iCardia4HF
Sponsored by
About this trial
This is an interventional treatment trial for Heart Failure focused on measuring heart failure, mHealth, smartphone, wearable electronic devices, text messaging, self-management, self-care
Eligibility Criteria
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
Sites / Locations
- University of Illinois Hospital & Health Sciences System
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
iCardia4HF
Control Group
Arm Description
Participants will be using a heart failure mobile app, wearable activity tracking device, Bluetooth-enabled blood pressure monitor and weight scale for self-monitoring, and receive tailored text-messages about self-care.
Participants assigned to the usual care group will receive standard medical care, which includes nurse-led patient education about HF self-care before discharge, and follow-up visits at the UI Health, outpatient Heart Failure program.
Outcomes
Primary Outcome Measures
Change from Baseline in Self-care at 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.
Change from Baseline in Health-related Quality of Life (HRQoL) at 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 Outcome Measures
Hospitalizations
The number of hospitalizations during the study will be measured with both self-report and the electronic medical record.
ER visits
The number of emergency room visits will be collected based on both self-reports and the electronic medical record
Full Information
NCT ID
NCT03642275
First Posted
June 15, 2018
Last Updated
April 8, 2021
Sponsor
University of Illinois at Chicago
1. Study Identification
Unique Protocol Identification Number
NCT03642275
Brief Title
Patient-centered Mobile Health Intervention to Improve Self-care in Patients With Chronic Heart Failure
Acronym
iCardia4HF
Official Title
iCardia4HF: A Patient-centered Mobile Health Intervention to Promote Self-care and Improve Patient Outcomes in Chronic Heart Failure
Study Type
Interventional
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
January 21, 2019 (Actual)
Primary Completion Date
February 15, 2020 (Actual)
Study Completion Date
February 15, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Illinois at Chicago
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
heart failure, mHealth, smartphone, wearable electronic devices, text messaging, self-management, self-care
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
Outcome assessors will be blinded to patients' randomization assignment
Allocation
Randomized
Enrollment
27 (Actual)
8. Arms, Groups, and Interventions
Arm Title
iCardia4HF
Arm Type
Experimental
Arm Description
Participants will be using a heart failure mobile app, wearable activity tracking device, Bluetooth-enabled blood pressure monitor and weight scale for self-monitoring, and receive tailored text-messages about self-care.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Participants assigned to the usual care group will receive standard medical care, which includes nurse-led patient education about HF self-care before discharge, and follow-up visits at the UI Health, outpatient Heart Failure program.
Intervention Type
Behavioral
Intervention Name(s)
iCardia4HF
Intervention Description
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 Outcome Measure Information:
Title
Change from Baseline in Self-care at 30 and 60 days
Description
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.
Time Frame
Baseline, 30 and 60 days
Title
Change from Baseline in Health-related Quality of Life (HRQoL) at 30 and 60 days
Description
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.
Time Frame
Baseline, 30 and 60 days
Secondary Outcome Measure Information:
Title
Hospitalizations
Description
The number of hospitalizations during the study will be measured with both self-report and the electronic medical record.
Time Frame
60 days
Title
ER visits
Description
The number of emergency room visits will be collected based on both self-reports and the electronic medical record
Time Frame
60 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Spyros Kitsiou, PhD
Organizational Affiliation
University of Illinois at Chicago
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Illinois Hospital & Health Sciences System
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Patient-centered Mobile Health Intervention to Improve Self-care in Patients With Chronic Heart Failure
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