An Innovative Mobile Health Intervention to Improve Self-care in Patients With Heart Failure
2 other identifiers
interventional
89
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable heart-failure
Started Feb 2020
Typical duration for not_applicable heart-failure
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 6, 2020
CompletedFirst Posted
Study publicly available on registry
February 10, 2020
CompletedStudy Start
First participant enrolled
February 20, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2022
CompletedApril 28, 2023
April 1, 2023
2.6 years
January 6, 2020
April 27, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Medication adherence (dose count)
Percent of prescribed number of doses taken
Weeks 1 to 12
Medication adherence (dose time)
Percent of doses taken on schedule within 25% of the expected time interval
Weeks 1 to 12
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 Outcomes (11)
Adherence to daily self-monitoring of blood pressure
Weeks 1 to 12
Adherence to self-monitoring of HF symptoms
Weeks 1 to 12
Physical activity - Steps
Weeks 1 to 12
Moderate-to-Vigorous Physical Activity
Weeks 1 to 12
Adherence to low-sodium diet
Baseline, 12 Weeks
- +6 more secondary outcomes
Other Outcomes (6)
HF-related hospitalizations
Weeks 1 to 12
HF-related hospitalization rate
Weeks 1 to 12
All-cause hospitalizations
Weeks 1 to 12
- +3 more other outcomes
Study Arms (2)
mHealth
EXPERIMENTALIntervention group
Usual Care
ACTIVE COMPARATORControl group
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Illinois at Chicagolead
- National Institute of Nursing Research (NINR)collaborator
- Indiana Universitycollaborator
- Rush University Medical Centercollaborator
Study Sites (1)
University of Illinois Hospital & Health Sciences System
Chicago, Illinois, 60612, United States
Related Publications (1)
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.
PMID: 33991686DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Spyros Kitsiou
University of Illinois at Chicago
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- CARE PROVIDER, OUTCOMES ASSESSOR
- Masking Details
- Care providers (doctors and nurses) providing usual care to study participants will be blinded to the allocation of participants. Data collectors and assessors of subjective outcomes (e.g. health beliefs, self-efficacy, self-care) will be blinded to the allocation. Study participants will be asked not to reveal to their provider and assessor which group they are assigned to. Data collectors/assessors will have restricted access to patient data in REDCap and will not share the same space with other study investigators.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
January 6, 2020
First Posted
February 10, 2020
Study Start
February 20, 2020
Primary Completion
September 30, 2022
Study Completion
December 31, 2022
Last Updated
April 28, 2023
Record last verified: 2023-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, CSR
- Time Frame
- Within 2 years after the final data collection is completed or within one year after the publication of the main outcomes manuscript (whichever comes first), we will share the final, completely de-identified dataset with the research community.
Final research data along with metadata and descriptors will be shared to make sharing meaningful and usable by other researchers. More specifically, we will share both de-identified individual-level data and aggregate data in the form of summary statistics and tables. For the individual-level data, we will develop a data dictionary and documentation guide to maximize the utility of the data and to help qualified researchers understand and properly use the data as needed.