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Terminated

NCT Number: NCT04755816

A 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.

Why the study stopped: Slow recruitment - DSMB decision
Terminated

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Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

University of Alabama at Birmingham, Birmingham, Alabama, United States

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About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Sodium intervention

Behavioral

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

Behavioral

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

Behavioral

Standard heart failure educational information and a daily symptom survey.

Primary outcomes

  1. 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 frame: 12 weeks

    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 diet intervention with every participant not receiving the diet 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.

  2. 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 frame: 12 weeks

    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 clinical worsening intervention with every participant not receiving the clinical worsening 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 outcomes

  1. All-Cause Mortality [ Time Frame: Baseline up to Week 12 ]

    Time frame: 12 weeks

    Time to all-cause mortality will be analyzed up to week 12.

  2. Heart Failure-related Hospitalizations [ Time Frame: Baseline up to Week 12 ]

    Time frame: 12 weeks

    Time to first heart-failure related hospitalization will be analyzed up to week 12.

  3. Change From Baseline in Health-related Quality of Life [ Time Frame: Baseline up to Week 12 ]

    Time frame: 12 weeks

    Change from baseline to week 12 in health-related quality of life as measured by the Minnesota Living with Heart Failure Questionnaire.

Interested in participating?

Terminated

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Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Collaborators

  • National Institute on Aging (NIA)

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Feb 16, 2021
Registry last updated
Sep 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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