Back to resultsHeart Failure Self-care Mobile Application to Reduce Readmissions Trial (HF-SMART)
Primary Purpose
Heart Failure
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mobile Health Technology Platform
Usual care
Sponsored by
About this trial
This is an interventional supportive care trial for Heart Failure focused on measuring readmission, quality of life, self-care
Eligibility Criteria
Inclusion Criteria:
- Inpatient admission for acute decompensated heart failure
- Left ventricular systolic or diastolic heart failure
- Owns a smartphone with a data plan
Exclusion Criteria:
- 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
Sites / Locations
- University of Pittsburgh
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Usual care
Application
Arm Description
Consists of routine care at the time of hospital discharge, to be provided at the discretion of the clinicians caring for the participant.
Participants will be provided a special link to navigate to the online content and resources.
Outcomes
Primary Outcome Measures
Percent of participants readmitted within 30 days
30-day readmission rate as determined by participant report or medical record query
Percent of participants readmitted within 90 days
90-day readmission rate as determined by participant report or medical record query
Time to readmission
time to readmission
Kansas City Cardiomyopathy Questionnaire at 30 days post enrollment
Quality of life, subjective level of function
Kansas City Cardiomyopathy Questionnaire at 90 days post enrollment
Quality of life, subjective level of function
Secondary Outcome Measures
Full Information
NCT ID
NCT03982017
First Posted
June 7, 2019
Last Updated
August 4, 2021
Sponsor
University of Pittsburgh
Collaborators
Agency for Healthcare Research and Quality (AHRQ)
1. Study Identification
Unique Protocol Identification Number
NCT03982017
Brief Title
Heart Failure Self-care Mobile Application to Reduce Readmissions Trial
Acronym
HF-SMART
Official Title
Heart Failure Self-care Mobile Application to Reduce Readmissions Trial
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Terminated
Why Stopped
Patient enrollment was initially suspended due to COVID19 pandemic, then the study was closed due to institutional requirements for clinical trials.
Study Start Date
July 12, 2019 (Actual)
Primary Completion Date
July 30, 2020 (Actual)
Study Completion Date
July 30, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pittsburgh
Collaborators
Agency for Healthcare Research and Quality (AHRQ)
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
readmission, quality of life, self-care
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
32 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Usual care
Arm Type
Active Comparator
Arm Description
Consists of routine care at the time of hospital discharge, to be provided at the discretion of the clinicians caring for the participant.
Arm Title
Application
Arm Type
Experimental
Arm Description
Participants will be provided a special link to navigate to the online content and resources.
Intervention Type
Other
Intervention Name(s)
Mobile Health Technology Platform
Other Intervention Name(s)
Smartphone Program
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Usual care
Intervention Description
Routine care at the time of hospital discharge, to be provided at the discretion of the clinicians caring for the participant.
Primary Outcome Measure Information:
Title
Percent of participants readmitted within 30 days
Description
30-day readmission rate as determined by participant report or medical record query
Time Frame
30 days post index discharge
Title
Percent of participants readmitted within 90 days
Description
90-day readmission rate as determined by participant report or medical record query
Time Frame
90 days post index discharge
Title
Time to readmission
Description
time to readmission
Time Frame
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
Title
Kansas City Cardiomyopathy Questionnaire at 30 days post enrollment
Description
Quality of life, subjective level of function
Time Frame
30 days post index discharge
Title
Kansas City Cardiomyopathy Questionnaire at 90 days post enrollment
Description
Quality of life, subjective level of function
Time Frame
90 days post index discharge
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Inpatient admission for acute decompensated heart failure
Left ventricular systolic or diastolic heart failure
Owns a smartphone with a data plan
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amber E Johnson, MD
Organizational Affiliation
University of Pittsburgh
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
35311679
Citation
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.
Results Reference
derived
Learn more about this trial
Heart Failure Self-care Mobile Application to Reduce Readmissions Trial
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