Study Stopped
Patient enrollment was initially suspended due to COVID19 pandemic, then the study was closed due to institutional requirements for clinical trials.
Heart Failure Self-care Mobile Application to Reduce Readmissions Trial
HF-SMART
2 other identifiers
interventional
32
1 country
1
Brief Summary
This is a patient-centered comparative effectiveness feasibility pilot designed to examine an intervention to increase heart failure self-care and symptom recognition. The investigators will randomize 100 participants to receive either usual care at the time of discharge after heart failure admission or a smartphone application that enhances self-care.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable heart-failure
Started Jul 2019
Shorter than P25 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
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 7, 2019
CompletedFirst Posted
Study publicly available on registry
June 11, 2019
CompletedStudy Start
First participant enrolled
July 12, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 30, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
July 30, 2020
CompletedAugust 12, 2021
August 1, 2021
1.1 years
June 7, 2019
August 4, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
Percent of participants readmitted within 30 days
30-day readmission rate as determined by participant report or medical record query
30 days post index discharge
Percent of participants readmitted within 90 days
90-day readmission rate as determined by participant report or medical record query
90 days post index discharge
Time to readmission
time to readmission
from the date of enrollment until the date of first documented admission or date of death from any cause, whichever comes first, assessed up to 90 days
Kansas City Cardiomyopathy Questionnaire at 30 days post enrollment
Quality of life, subjective level of function
30 days post index discharge
Kansas City Cardiomyopathy Questionnaire at 90 days post enrollment
Quality of life, subjective level of function
90 days post index discharge
Study Arms (2)
Usual care
ACTIVE COMPARATORConsists of routine care at the time of hospital discharge, to be provided at the discretion of the clinicians caring for the participant.
Application
EXPERIMENTALParticipants will be provided a special link to navigate to the online content and resources.
Interventions
When the participant navigates to the program, s/he will follow the directions on how to use the program, sign the terms of agreement, put in a password and begin the welcome page. The participant will receive daily prompts to complete brief questionnaires and review specialized content.
Routine care at the time of hospital discharge, to be provided at the discretion of the clinicians caring for the participant.
Eligibility Criteria
You may qualify if:
- Inpatient admission for acute decompensated heart failure
- Left ventricular systolic or diastolic heart failure
- Owns a smartphone with a data plan
You may not qualify if:
- Hospice or life expectancy less than 6 months
- Palliative inotrope use
- Heart transplant listed, or status post transplant
- Ventricular assist devise present, or awaiting placement
- Not being discharged to home
- Unable to provide consent or comply with the intervention
- Current enrollment in a remote monitoring/ telehealth program
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213, United States
Related Publications (1)
Johnson AE, Routh S, Taylor CN, Leopold M, Beatty K, McNamara DM, Davis EM. Developing and Implementing an mHealth Heart Failure Self-care Program to Reduce Readmissions: Randomized Controlled Trial. JMIR Cardio. 2022 Mar 21;6(1):e33286. doi: 10.2196/33286.
PMID: 35311679DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Amber E Johnson, MD
University of Pittsburgh
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
June 7, 2019
First Posted
June 11, 2019
Study Start
July 12, 2019
Primary Completion
July 30, 2020
Study Completion
July 30, 2020
Last Updated
August 12, 2021
Record last verified: 2021-08
Data Sharing
- IPD Sharing
- Will not share