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A Mobile Application to Promote Self-management and Improve Outcomes in Heart Failure

Primary Purpose

Heart Failure

Status
Terminated
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Sodium intervention
Clinical worsening intervention
Educational content
Sponsored by
University of Michigan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Heart Failure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Age 18 years and older at screening
  2. Currently admitted or discharged from the hospital within the last 7 days with a diagnosis of acute or acute on chronic decompensated HF
  3. Left ventricular ejection fraction (LVEF) ≤ 40% or an LVEF >40% (with left atrial size >40mm or BNP > 200 pg/ml or NT-proBNP > 800 pg/ml). LVEF within 12 months of randomization. BNP or NT-proBNP criteria within 30 days prior to randomization.
  4. Have a personal physician for follow-up
  5. A smartphone with Apple or Android operating system installed and able to download and use ManageHF
  6. A valid email address
  7. Fluent in spoken and written English
  8. Signed written informed consent

Exclusion Criteria:

  1. Contraindication to recommending a sodium restriction diet
  2. Acute coronary syndrome, stroke, transient ischemic attack, cardiac, carotid, or other major cardiovascular surgery, PCI, or carotid angioplasty within 3 months prior to screening
  3. Planned intervention for primary valvular heart disease will occur during the study period
  4. Cardiac resynchronization therapy (CRT) within 3 months prior to screening or current plan to implant CRT device during the study period.
  5. Known active myocarditis, hypertrophic obstructive cardiomyopathy, pericarditis, cardiac amyloidosis, or restrictive cardiomyopathy
  6. Complex congenital heart disease
  7. Severe stenotic valvular disease
  8. Severe uncorrected thyroid disease
  9. End stage renal disease (dialysis or creatinine >4.0 mg/dL)
  10. End stage liver disease
  11. Previous cardiac transplantation or implantation of a ventricular assistance device or similar device, or implantation expected within 6 months after randomization
  12. Cardiac (including end stage HF) or non-cardiac illness with expected survival less than 6 months
  13. Oxygen-dependent lung disease
  14. Discharge to a setting other than home
  15. Requirement for chronic inotropic therapy (e.g. milrinone, dobutamine).
  16. Currently pregnant or intent to become pregnant during the study period.

Sites / Locations

  • University of Alabama at Birmingham
  • Stanford University
  • Emory University
  • Atlanta VA Health Care System
  • University of Michigan
  • Henry Ford Hospital System
  • Washington University in St. Louis
  • University of North Carolina at Chapel Hill
  • Virginia Commonwealth University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Sham Comparator

Experimental

Experimental

Experimental

Arm Label

Control Group

Dietary Sodium Intervention

Clinical Worsening Intervention

Dietary Sodium and Clinical Worsening

Arm Description

Standard heart failure educational information.

The dietary sodium intervention facilitates lower sodium choices using tailored push notifications.

The clinical worsening intervention promotes self-monitoring and self-management and is linked tailored push notifications.

Full access to all content in the control, dietary sodium, and clinical worsening interventions.

Outcomes

Primary Outcome Measures

Hierarchical combination ("win ratio") of time to all-cause mortality, time to heart failure hospital readmission, and decline in health-related quality of life (HRQOL) [ Time Frame: Baseline up to Week 12 ]
Time to all-cause mortality (ACM), time to heart failure hospital readmission (HFHR), and decline in quality of life will be analyzed using the Finkelstein-Schoenfeld method. The method combines these three endpoints in a hierarchical fashion using ACM first, HRHR second, and change in HRQOL third. The method pairs every participant receiving the intervention with every participant not receiving the intervention within each stratum. Within each pairing, a +1 is assigned to the "better" participant, -1 to the "worse" participant, and 0 if they are "tied". The comparison begins with ACM. Tied pairings are then compared using HFHR. Any remaining tied pairings are compared using change in HRQOL. A 'Win' represents a participant doing better within each pairing (receiving +1) based on the hierarchical comparison. The reported unit is the total "wins" for each intervention group from performing such a hierarchical comparison across all strata.

Secondary Outcome Measures

All-Cause Mortality [ Time Frame: Baseline up to Week 12 ]
Time to all-cause mortality will be analyzed up to week 12.
Heart failure-related hospitalizations [ Time Frame: Baseline to Week 12 ]
Time to first heart-failure related hospitalization will be analyzed up to week 12.
Change from baseline in health-related quality of life [ Time Frame: Baseline, Week 12 ]
Change from baseline to week 12 in health-related quality of life as measured by the Minnesota Living with Heart Failure Questionnaire.

Full Information

First Posted
January 27, 2021
Last Updated
June 7, 2023
Sponsor
University of Michigan
Collaborators
National Institute on Aging (NIA)
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1. Study Identification

Unique Protocol Identification Number
NCT04755816
Brief Title
A Mobile Application to Promote Self-management and Improve Outcomes in Heart Failure
Official Title
A Multifaceted Adaptive Mobile Application to Promote Self-management and Improve Outcomes in Heart Failure
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Terminated
Why Stopped
Slow recruitment - DSMB decision
Study Start Date
June 14, 2021 (Actual)
Primary Completion Date
May 8, 2023 (Actual)
Study Completion Date
May 17, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan
Collaborators
National Institute on Aging (NIA)

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 study will investigate the effectiveness of two contextual just-in-time adaptive interventions (JITAIs) delivered via a mobile app for heart failure patients.
Detailed Description
The Manage HF study is a multicenter 12-week randomized controlled double-blind 2x2 factorial clinical trial. This study will investigate the effectiveness of two contextual just-in-time adaptive interventions (JITAIs) delivered via a mobile app for heart failure patients. The clinical worsening intervention targets self-management of behaviors to prevent worsening of a patient's heart failure symptoms. The dietary sodium intervention promotes lower sodium intake. Eligible participants will be randomized to the dietary sodium intervention, the clinical worsening intervention, both interventions, or no intervention in a 1:1:1:1 manner, stratified by site, gender, and HF type (HFpEF versus HFrEF).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 3
Interventional Study Model
Factorial Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
62 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control Group
Arm Type
Sham Comparator
Arm Description
Standard heart failure educational information.
Arm Title
Dietary Sodium Intervention
Arm Type
Experimental
Arm Description
The dietary sodium intervention facilitates lower sodium choices using tailored push notifications.
Arm Title
Clinical Worsening Intervention
Arm Type
Experimental
Arm Description
The clinical worsening intervention promotes self-monitoring and self-management and is linked tailored push notifications.
Arm Title
Dietary Sodium and Clinical Worsening
Arm Type
Experimental
Arm Description
Full access to all content in the control, dietary sodium, and clinical worsening interventions.
Intervention Type
Behavioral
Intervention Name(s)
Sodium intervention
Intervention Description
The sodium dietary intervention provides uses location services to determine when a participant is at home, arrives at a grocery store or arrives at a restaurant. The user receives a tailored message to assist with making dietary choices based on sodium content.
Intervention Type
Behavioral
Intervention Name(s)
Clinical worsening intervention
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Educational content
Intervention Description
Standard heart failure educational information and a daily symptom survey.
Primary Outcome Measure Information:
Title
Hierarchical combination ("win ratio") of time to all-cause mortality, time to heart failure hospital readmission, and decline in health-related quality of life (HRQOL) [ Time Frame: Baseline up to Week 12 ]
Description
Time to all-cause mortality (ACM), time to heart failure hospital readmission (HFHR), and decline in quality of life will be analyzed using the Finkelstein-Schoenfeld method. The method combines these three endpoints in a hierarchical fashion using ACM first, HRHR second, and change in HRQOL third. The method pairs every participant receiving the intervention with every participant not receiving the intervention within each stratum. Within each pairing, a +1 is assigned to the "better" participant, -1 to the "worse" participant, and 0 if they are "tied". The comparison begins with ACM. Tied pairings are then compared using HFHR. Any remaining tied pairings are compared using change in HRQOL. A 'Win' represents a participant doing better within each pairing (receiving +1) based on the hierarchical comparison. The reported unit is the total "wins" for each intervention group from performing such a hierarchical comparison across all strata.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
All-Cause Mortality [ Time Frame: Baseline up to Week 12 ]
Description
Time to all-cause mortality will be analyzed up to week 12.
Time Frame
12 weeks
Title
Heart failure-related hospitalizations [ Time Frame: Baseline to Week 12 ]
Description
Time to first heart-failure related hospitalization will be analyzed up to week 12.
Time Frame
12 weeks
Title
Change from baseline in health-related quality of life [ Time Frame: Baseline, Week 12 ]
Description
Change from baseline to week 12 in health-related quality of life as measured by the Minnesota Living with Heart Failure Questionnaire.
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 18 years and older at screening Currently admitted or discharged from the hospital within the last 14 days with a diagnosis of acute or acute on chronic decompensated HF. 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. Have a personal physician for follow-up A smartphone with a compatible Apple or Android operating system installed and able to download and use ManageHF including accepting all permissions A valid email address Fluent in spoken and written English Exclusion Criteria: Contraindication to recommending a sodium restriction diet Scheduled intervention for primary valvular heart disease will occur during the study period. Cardiac resynchronization therapy (CRT) within 3 months prior to screening or current plan to implant CRT device during the study period. Dialysis Previous cardiac transplantation or implantation of a ventricular assistance device or similar device. Listed status 1, 2 or 3 for heart transplant Implantation of a ventricular assistance device is expected within 3 months after randomization Non-cardiac illness with expected survival of less than 3 months Discharge to a setting other than home Requirement for chronic inotropic therapy (e.g. milrinone, dobutamine) Inability to use Withings devices due to equipment limitations or contraindications Currently pregnant or intend to become pregnant during the study period.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Dorsch, PharmD
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
Stanford University
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Atlanta VA Health Care System
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30033
Country
United States
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Henry Ford Hospital System
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Washington University in St. Louis
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63130
Country
United States
Facility Name
University of North Carolina at Chapel Hill
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27514
Country
United States
Facility Name
Virginia Commonwealth University
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23284
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
The aim is to prepare data for deposit into the National Institute on Aging supported National Archive of Computerized Data on Aging data repository. The de-identified analytic data will be prepared as SAS transport files or ASCII comma-delimited files with accompanying codebooks that describe the data and data structure. The redaction will employ best practices and will be consistent with National Institute on Aging data sharing policies.
IPD Sharing Time Frame
No later than 3 years after the end of the study or 2 years after the main paper reporting the results of the trial, whichever comes first.
IPD Sharing Access Criteria
Researchers at institutions with a Federal Wide Assurance will be able to gain access to repository data by submitting a data access request in accordance with applicable policies.

Learn more about this trial

A Mobile Application to Promote Self-management and Improve Outcomes in Heart Failure

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