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

University of Michigan

Status and phase: Terminated; Phase 3

Conditions: Heart Failure

Treatments: Behavioral: Sodium intervention; Behavioral: Clinical worsening intervention; Behavioral: Educational content

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04755816

R01AG062582-01A1 (U.S. NIH Grant/Contract)

HUM00181316

Details and patient eligibility

About

This study will investigate the effectiveness of two contextual just-in-time adaptive interventions (JITAIs) delivered via a mobile app for heart failure patients.

Full 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).

Enrollment: 62 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Quadruple Blind

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62 participants in 4 patient groups

Control Group 'A'

Sham Comparator group

Description:

Standard heart failure educational information.

Treatment:

Behavioral: Educational content

Dietary Sodium Intervention 'B'

Experimental group

Description:

The dietary sodium intervention facilitates lower sodium choices using tailored push notifications.

Treatment:

Behavioral: Sodium intervention

Clinical Worsening Intervention 'C'

Experimental group

Description:

The clinical worsening intervention promotes self-monitoring and self-management and is linked tailored push notifications.

Treatment:

Behavioral: Clinical worsening intervention

Dietary Sodium and Clinical Worsening 'D'

Experimental group

Description:

Full access to all content in the control, dietary sodium, and clinical worsening interventions.

Treatment:

Behavioral: Clinical worsening intervention

Behavioral: Sodium intervention