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

Phase 3

Terminated

• Conditions: Heart Failure
• Interventions: Behavioral: Educational content; Behavioral: Sodium intervention; Behavioral: Clinical worsening intervention

• Registration Number: NCT04755816
• Lead Sponsor: University of Michigan

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).

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study First Submitted: 2021-01-27
• Study First Submitted QC: 2021-02-10
• Study First Posted: 2021-02-16
• Study Start: 2021-06-14
• Primary Completion: 2023-05-08
• Study Completion: 2023-05-17
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-07
• Last Update Posted: 2023-06-08

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 62

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

Read More

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.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Control Group 'A'	Educational content	Standard heart failure educational information.
Dietary Sodium Intervention 'B'	Sodium intervention	The dietary sodium intervention facilitates lower sodium choices using tailored push notifications.
Clinical Worsening Intervention 'C'	Clinical worsening intervention	The clinical worsening intervention promotes self-monitoring and self-management and is linked tailored push notifications.
Dietary Sodium and Clinical Worsening 'D'	Sodium intervention	Full access to all content in the control, dietary sodium, and clinical worsening interventions.
Dietary Sodium and Clinical Worsening 'D'	Clinical worsening intervention	Full access to all content in the control, dietary sodium, and clinical worsening interventions.

Primary Outcome Measures

Name	Time	Method
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 ]	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 Outcome Measures

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

Trial Locations

Locations (9)

University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States

Emory University; 🇺🇸 Atlanta, Georgia, United States

Atlanta VA Health Care System; 🇺🇸 Decatur, Georgia, United States

Henry Ford Hospital System; 🇺🇸 Detroit, Michigan, United States

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States

Washington University in St. Louis; 🇺🇸 Saint Louis, Missouri, United States

Virginia Commonwealth University; 🇺🇸 Richmond, Virginia, United States

University of North Carolina at Chapel Hill; 🇺🇸 Chapel Hill, North Carolina, United States

Stanford University; 🇺🇸 Stanford, California, United States