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

Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04755816
• Other study ID #: HUM00181316
• Secondary ID: R01AG062582-01A1
• Status: Terminated
• Phase: Phase 3
• Start date: June 14, 2021
• Est. completion date: May 17, 2023

Study information

• Verified date: June 2023
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 62
• Est. completion date: May 17, 2023
• Est. primary completion date: May 8, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Heart Failure

Intervention

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.
• 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.
• Educational content
Standard heart failure educational information and a daily symptom survey.

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan
United States	Emory University	Atlanta	Georgia
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	University of North Carolina at Chapel Hill	Chapel Hill	North Carolina
United States	Atlanta VA Health Care System	Decatur	Georgia
United States	Henry Ford Hospital System	Detroit	Michigan
United States	Virginia Commonwealth University	Richmond	Virginia
United States	Washington University in St. Louis	Saint Louis	Missouri
United States	Stanford University	Stanford	California

Sponsors (2)

Lead Sponsor	Collaborator
University of Michigan	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	All-Cause Mortality [ Time Frame: Baseline up to Week 12 ]	Time to all-cause mortality will be analyzed up to week 12.	12 weeks
Secondary	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
Secondary	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