LiveSMART Trial to Prevent Falls in Patients With Cirrhosis - Supplementary Study

University of Michigan

Status: Active, not recruiting

Conditions: Portal Hypertension; Cirrhosis, Liver

Study type: Observational

Funder types: Other

Identifiers

NCT07140120

CER-2021C3-24907 (Other Identifier)

HUM00225275-B

Details and patient eligibility

About

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.

Full 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.

Enrollment: 52 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Adult 18 years of age or older
• Informal caregiver of a participant enrolled in LIVE-SMART
• English speaking

Exclusion criteria

• Non-English speaking

Trial design

52 participants in 1 patient group

Caregivers

Description:

Caregivers are a relative, spouse, partner, friend or neighbor who has a significant personal relationship with and provides a broad range of assistance for a patient, including consistent involvement in their medical care.