Clinical trial NCT04755816: 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
Overall status: TERMINATED
Phase: PHASE3
Conditions: Heart Failure
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2021-02-16
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: SUPPORTIVE_CARE

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).

Eligibility criteria: 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.

Primary outcomes:
measure: 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 ]
timeFrame: 12 weeks
measure: 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 ]
timeFrame: 12 weeks
Secondary outcomes:
measure: All-Cause Mortality [ Time Frame: Baseline up to Week 12 ]
timeFrame: 12 weeks
measure: Heart Failure-related Hospitalizations [ Time Frame: Baseline up to Week 12 ]
timeFrame: 12 weeks
measure: Change From Baseline in Health-related Quality of Life [ Time Frame: Baseline up to Week 12 ]
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Stanford
country: United States
facility: Stanford University
state: California
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Decatur
country: United States
facility: Atlanta VA Health Care System
state: Georgia
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Detroit
country: United States
facility: Henry Ford Hospital System
state: Michigan
city: Saint Louis
country: United States
facility: Washington University in St. Louis
state: Missouri
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill
state: North Carolina
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
Study officials:
affiliation: University of Michigan
name: Michael Dorsch, PharmD
role: PRINCIPAL_INVESTIGATOR
References: