A Mobile Application to Promote Self-management and Improve Outcomes in Heart Failure
NCT ID: NCT04755816
Last Updated: 2024-09-19
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE3
62 participants
INTERVENTIONAL
2021-06-14
2023-05-17
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
FACTORIAL
SUPPORTIVE_CARE
QUADRUPLE
Study Groups
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Control Group 'A'
Standard heart failure educational information.
Educational content
Standard heart failure educational information and a daily symptom survey.
Dietary Sodium Intervention 'B'
The dietary sodium intervention facilitates lower sodium choices using tailored push notifications.
Sodium intervention
The sodium dietary intervention provides the user with a tailored message to assist with making dietary choices based on sodium content when they arrive at a grocery store or restaurant.
Clinical Worsening Intervention 'C'
The clinical worsening intervention promotes self-monitoring and self-management and is linked tailored push notifications.
Clinical worsening intervention
The intervention adapts to the participant's reported symptoms and provides feedback with a global health status indicator (HSI). Users will receive tailored push notification based on their HSI status.
Dietary Sodium and Clinical Worsening 'D'
Full access to all content in the control, dietary sodium, and clinical worsening interventions.
Sodium intervention
The sodium dietary intervention provides the user with a tailored message to assist with making dietary choices based on sodium content when they arrive at a grocery store or restaurant.
Clinical worsening intervention
The intervention adapts to the participant's reported symptoms and provides feedback with a global health status indicator (HSI). Users will receive tailored push notification based on their HSI status.
Interventions
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Sodium intervention
The sodium dietary intervention provides the user with a tailored message to assist with making dietary choices based on sodium content when they arrive at a grocery store or restaurant.
Clinical worsening intervention
The intervention adapts to the participant's reported symptoms and provides feedback with a global health status indicator (HSI). Users will receive tailored push notification based on their HSI status.
Educational content
Standard heart failure educational information and a daily symptom survey.
Eligibility Criteria
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Inclusion Criteria
2. Currently admitted or discharged from the hospital within the last 14 days with a diagnosis of acute or acute on chronic decompensated HF.
3. Based on one of the EF criteria (LVEF within 12 months of randomization. BNP or NT-proBNP criteria within 30 days prior to randomization):
* Left ventricular ejection fraction (LVEF) ≤ 40%.
* LVEF \>40% and BNP \> 175 pg/ml or NT-proBNP \> 700 pg/ml. Thresholds for NT-proBNP and BNP for LVEF \> 40% will be corrected for body mass index (BMI) using a 4% reduction per BMI unit over 25 kg/m2.
4. Have a personal physician for follow-up
5. A smartphone with a compatible Apple or Android operating system installed and able to download and use ManageHF including accepting all permissions
6. A valid email address
7. Fluent in spoken and written English
Exclusion Criteria
2. Scheduled intervention for primary valvular heart disease will occur during the study period.
3. Cardiac resynchronization therapy (CRT) within 3 months prior to screening or current plan to implant CRT device during the study period.
4. Dialysis
5. Previous cardiac transplantation or implantation of a ventricular assistance device or similar device.
6. Listed status 1, 2 or 3 for heart transplant
7. Implantation of a ventricular assistance device is expected within 3 months after randomization
8. Non-cardiac illness with expected survival of less than 3 months
9. Discharge to a setting other than home
10. Requirement for chronic inotropic therapy (e.g. milrinone, dobutamine)
11. Inability to use Withings devices due to equipment limitations or contraindications
12. Currently pregnant or intend to become pregnant during the study period.
18 Years
ALL
No
Sponsors
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National Institute on Aging (NIA)
NIH
University of Michigan
OTHER
Responsible Party
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Michael Dorsch
Associate Professor of Clinical Pharmacy
Principal Investigators
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Michael Dorsch, PharmD
Role: PRINCIPAL_INVESTIGATOR
University of Michigan
Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
Stanford University
Stanford, California, United States
Emory University
Atlanta, Georgia, United States
Atlanta VA Health Care System
Decatur, Georgia, United States
University of Michigan
Ann Arbor, Michigan, United States
Henry Ford Hospital System
Detroit, Michigan, United States
Washington University in St. Louis
St Louis, Missouri, United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
Virginia Commonwealth University
Richmond, Virginia, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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HUM00181316
Identifier Type: -
Identifier Source: org_study_id
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