Ignite Creation Date:
2024-05-06 @ 3:47 PM
Last Modification Date:
2024-10-26 @ 1:57 PM
Study NCT ID:
NCT04755816
Status:
TERMINATED
Last Update Posted:
2023-06-08
First Post:
2021-01-27
Brief Title:
A Mobile Application to Promote Self-management and Improve Outcomes in Heart Failure
Sponsor:
University of Michigan
Organization:
University of Michigan
Study Overview
Official Title:
A Multifaceted Adaptive Mobile Application to Promote Self-management and Improve Outcomes in Heart Failure
Status:
TERMINATED
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Slow recruitment - DSMB decision
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 patients 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 1111 manner stratified by site gender and HF type HFpEF versus HFrEF
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01AG062582-01A1 | NIH | None | httpsreporternihgovquickSearchR01AG062582-01A1 |