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

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

This study will investigate the effectiveness of two contextual just-in-time adaptive interventions (JITAIs) delivered via a mobile app for heart failure patients.

Study Overview

• Status: Terminated
• Conditions: Heart Failure
• Intervention / Treatment: Behavioral: Educational content; Behavioral: Sodium intervention; Behavioral: Clinical worsening intervention

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).

• Study Type: Interventional
• Enrollment (Actual): 62
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • University of Alabama at Birmingham
  • California
    • Stanford, California, United States, 94305
      • Stanford University
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Emory University
    • Decatur, Georgia, United States, 30033
      • Atlanta VA Health Care System
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan
    • Detroit, Michigan, United States, 48202
      • Henry Ford Hospital System
  • Missouri
    • Saint Louis, Missouri, United States, 63130
      • Washington University in St. Louis
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27514
      • University of North Carolina at Chapel Hill
  • Virginia
    • Richmond, Virginia, United States, 23284
      • Virginia Commonwealth University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Age 18 years and older at screening
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:

1. Contraindication to recommending a sodium restriction diet
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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: Control Group; Standard heart failure educational information.	Behavioral: Educational content; Standard heart failure educational information and a daily symptom survey.
Experimental: Dietary Sodium Intervention; The dietary sodium intervention facilitates lower sodium choices using tailored push notifications.	Behavioral: Sodium intervention; 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.
Experimental: Clinical Worsening Intervention; The clinical worsening intervention promotes self-monitoring and self-management and is linked tailored push notifications.	Behavioral: 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.
Experimental: Dietary Sodium and Clinical Worsening; Full access to all content in the control, dietary sodium, and clinical worsening interventions.	Behavioral: Sodium intervention; 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.; Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
All-Cause Mortality [ Time Frame: Baseline up to Week 12 ]	Time to all-cause mortality will be analyzed up to week 12.	12 weeks
Heart failure-related hospitalizations [ Time Frame: Baseline to Week 12 ]	Time to first heart-failure related hospitalization will be analyzed up to week 12.	12 weeks
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.	12 weeks

Collaborators and Investigators

• Sponsor: University of Michigan
• Collaborators: National Institute on Aging (NIA)
• Investigators: Principal Investigator: Michael Dorsch, PharmD, University of Michigan

Study record dates

Study Major Dates

• Study Start (Actual): June 14, 2021
• Primary Completion (Actual): May 8, 2023
• Study Completion (Actual): May 17, 2023

Study Registration Dates

• First Submitted: January 27, 2021
• First Submitted That Met QC Criteria: February 10, 2021
• First Posted (Actual): February 16, 2021

Study Record Updates

• Last Update Posted (Actual): June 8, 2023
• Last Update Submitted That Met QC Criteria: June 7, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: HUM00181316; R01AG062582-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No