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

Study Overview
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Brief Summary
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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
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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).

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

Conditions
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Heart Failure

Intervention / Treatment
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* Behavioral: Sodium intervention
* Behavioral: Clinical worsening intervention
* Behavioral: Educational content


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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 |