- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03982017
Heart Failure Self-care Mobile Application to Reduce Readmissions Trial (HF-SMART)
August 4, 2021 updated by: Amber Johnson, University of Pittsburgh
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.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
32
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Pennsylvania
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Pittsburgh, Pennsylvania, United States, 15213
- University of Pittsburgh
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Usual care
Consists of routine care at the time of hospital discharge, to be provided at the discretion of the clinicians caring for the participant.
|
Routine care at the time of hospital discharge, to be provided at the discretion of the clinicians caring for the participant.
|
Experimental: Application
Participants will be provided a special link to navigate to the online content and resources.
|
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percent of participants readmitted within 30 days
Time Frame: 30 days post index discharge
|
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
Time Frame: 90 days post index discharge
|
90-day readmission rate as determined by participant report or medical record query
|
90 days post index discharge
|
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
|
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
Time Frame: 30 days post index discharge
|
Quality of life, subjective level of function
|
30 days post index discharge
|
Kansas City Cardiomyopathy Questionnaire at 90 days post enrollment
Time Frame: 90 days post index discharge
|
Quality of life, subjective level of function
|
90 days post index discharge
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Amber E Johnson, MD, University of Pittsburgh
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 12, 2019
Primary Completion (Actual)
July 30, 2020
Study Completion (Actual)
July 30, 2020
Study Registration Dates
First Submitted
June 7, 2019
First Submitted That Met QC Criteria
June 7, 2019
First Posted (Actual)
June 11, 2019
Study Record Updates
Last Update Posted (Actual)
August 12, 2021
Last Update Submitted That Met QC Criteria
August 4, 2021
Last Verified
August 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- STUDY18110012
- K12HS019461 (U.S. AHRQ Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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