NCT04755816

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

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

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 62 (actual)
• Sponsor: University of Michigan · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Heart Failure

Interventions

Type	Name	Description
BEHAVIORAL	Sodium intervention	The sodium dietary intervention provides the user with a tailored message to assist with making dietary choices based on sodium content when they arrive at a grocery store or restaurant.
BEHAVIORAL	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.
BEHAVIORAL	Educational content	Standard heart failure educational information and a daily symptom survey.

Timeline

• Start date: 2021-06-14
• Primary completion: 2023-05-08
• Completion: 2023-05-17
• First posted: 2021-02-16
• Last updated: 2024-09-19
• Results posted: 2024-09-19

Locations

9 sites across 1 country: United States