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出境医 / 临床实验 / Heart Failure Self-care Mobile Application to Reduce Readmissions Trial (HF-SMART)

Heart Failure Self-care Mobile Application to Reduce Readmissions Trial (HF-SMART)

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.

Condition or disease Intervention/treatment Phase
Heart Failure Other: Mobile Health Technology Platform Other: Usual care Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Heart Failure Self-care Mobile Application to Reduce Readmissions Trial
Actual Study Start Date : July 12, 2019
Actual Primary Completion Date : July 30, 2020
Estimated Study Completion Date : July 2021
Arms and Interventions
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.
 Other: Usual care
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.
 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.
Other Name: Smartphone Program
Outcome Measures
Primary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. Kansas City Cardiomyopathy Questionnaire at 30 days post enrollment [ Time Frame: 30 days post index discharge ]
    Quality of life, subjective level of function

  5. Kansas City Cardiomyopathy Questionnaire at 90 days post enrollment [ Time Frame: 90 days post index discharge ]
    Quality of life, subjective level of function


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Locations
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United States, Pennsylvania
University of Pittsburgh Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Amber E Johnson, MD    412-648-6598    johnsonae2@upmc.edu   
Principal Investigator: Amber E Johnson, MD         
Sponsors and Collaborators
University of Pittsburgh
Agency for Healthcare Research and Quality (AHRQ)
Investigators
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Principal Investigator: Amber E Johnson, MD University of Pittsburgh
Tracking Information
First Submitted Date  ICMJE June 7, 2019
First Posted Date  ICMJE June 11, 2019
Last Update Posted Date August 5, 2020
Actual Study Start Date  ICMJE July 12, 2019
Actual Primary Completion Date July 30, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 7, 2019)
  • 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
  • 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
  • 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
  • Kansas City Cardiomyopathy Questionnaire at 30 days post enrollment [ Time Frame: 30 days post index discharge ]
    Quality of life, subjective level of function
  • Kansas City Cardiomyopathy Questionnaire at 90 days post enrollment [ Time Frame: 90 days post index discharge ]
    Quality of life, subjective level of function
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Heart Failure Self-care Mobile Application to Reduce Readmissions Trial
Official Title  ICMJE Heart Failure Self-care Mobile Application to Reduce Readmissions Trial
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE Heart Failure
Intervention  ICMJE
  • 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.
    Other Name: Smartphone Program
  • Other: Usual care
    Routine care at the time of hospital discharge, to be provided at the discretion of the clinicians caring for the participant.
Study Arms  ICMJE
  • 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.
    Intervention: Other: Usual care
  • Experimental: Application
    Participants will be provided a special link to navigate to the online content and resources.
    Intervention: Other: Mobile Health Technology Platform
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 7, 2019) 		100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 2021
Actual Primary Completion Date July 30, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03982017
Other Study ID Numbers  ICMJE STUDY18110012
K12HS019461 ( U.S. AHRQ Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Amber Johnson, University of Pittsburgh
Study Sponsor  ICMJE University of Pittsburgh
Collaborators  ICMJE Agency for Healthcare Research and Quality (AHRQ)
Investigators  ICMJE
Principal Investigator: Amber E Johnson, MD University of Pittsburgh
PRS Account University of Pittsburgh
Verification Date August 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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