Heart Failure Self-care Mobile Application to Reduce Readmissions Trial

Heart Failure Clinical Trial

— HF-SMART  

Official title:

Heart Failure Self-care Mobile Application to Reduce Readmissions Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03982017
• Other study ID #: STUDY18110012
• Secondary ID: K12HS019461
• Status: Terminated
• Phase: N/A
• Start date: July 12, 2019
• Est. completion date: July 30, 2020

Study information

• Verified date: August 2021
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 32
• Est. completion date: July 30, 2020
• Est. primary completion date: July 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure

Intervention

Other:
• Mobile Health Technology Platform
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.
• Usual care
Routine care at the time of hospital discharge, to be provided at the discretion of the clinicians caring for the participant.

Locations

Country	Name	City	State
United States	University of Pittsburgh	Pittsburgh	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pittsburgh	Agency for Healthcare Research and Quality (AHRQ)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	Kansas City Cardiomyopathy Questionnaire at 30 days post enrollment	Quality of life, subjective level of function	30 days post index discharge
Primary	Kansas City Cardiomyopathy Questionnaire at 90 days post enrollment	Quality of life, subjective level of function	90 days post index discharge