Ignite Creation Date:
2025-12-25 @ 4:12 AM
Ignite Modification Date:
2025-12-26 @ 3:11 AM
Study NCT ID:
NCT07140120
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-08-24
First Post:
2025-08-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
LiveSMART Trial to Prevent Falls in Patients With Cirrhosis - Supplementary Study
Sponsor:
University of Michigan
Organization:
Study Overview
Official Title:
LiveSMART: A Sequential, Multiple Assignment Randomized Trial to Prevent Falls in Patients With Cirrhosis - Observational Study
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
LiveSMART
Brief Summary:
The LIVE-SMART supplementary study will assess social determinants of health (income, education, neighborhood deprivation), financial burden (out-of-pocket costs, productivity loss), financial distress (patient and caregiver-reported outcomes), and financial toxicity (healthcare utilization) among LIVE-SMART participants and their caregivers.
Participants for this supplementary study are participants in the primary study (NCT05794555) and their caregivers.
Participants for this supplementary study are participants in the primary study (NCT05794555) and their caregivers.
Detailed Description:
The supplementary study will augment the primary study the following ways: 1) adding longitudinal questionnaires about financial burden, distress, and toxicity among patients and their caregivers, 2) assessing detailed data and healthcare utilization and associated costs, 3) extending study follow-up by 48 weeks from 24 to 72 weeks.
Study Oversight
Has Oversight DMC:
False
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| CER-2021C3-24907 | OTHER_GRANT | Patient-Centered Outcomes Research Institute (PCORI) | View |