Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06542575
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-04
Brief Title:
Efficacy of the Integration of Digital Therapeutics and Home-based Cardiac Rehabilitation in High-Risk Post-PCI Patients
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Efficacy of the Integration of Digital Therapeutics and Home-based Cardiac Rehabilitation in High-Risk Post-PCI Patients on Cardiovascular Health
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The DTx-HBCR trial will randomize 366 high-risk patients who undergo PCI at the West China Hospital of Sichuan University to either the 6-month DTx-guided HBCR group intervention group or the 6-months usual care group control group in a parallel-arm randomized controlled trial The primary outcome is the difference between the intervention group and control group in walk distance on the 6-minute walk test ie functional capacity at 6 months post randomization The key secondary outcomes include improvements in cardiovascular risk factor control quality of life psychological status physical activity major adverse cardiovascular events and medication adherence This study aims to evaluate the DTx-guided HBCR a software-driven multidisciplinary health intervention as an alternative to traditional in-center CR in patients with high-risk patients following percutaneous coronary intervention PCI compared with usual care alone
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None