NCT07140120

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P25-P50 for all trials

Timeline
1mo left

Started Jun 2023

Typical duration for all trials

Geographic Reach
1 country

3 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress98%
Jun 2023Jun 2026

Study Start

First participant enrolled

June 13, 2023

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

August 18, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 24, 2025

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 27, 2026

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2026

Expected
Last Updated

April 29, 2026

Status Verified

February 1, 2026

Enrollment Period

2.8 years

First QC Date

August 18, 2025

Last Update Submit

April 23, 2026

Conditions

Cirrhosis, LiverPortal Hypertension

Keywords

Exercise programLactuloseTai-ChiFall preventionDietary Protein

Outcome Measures

Primary Outcomes (1)

  • Comprehensive Score for Financial Toxicity - Functional Assessment of Chronic Illness Therapy v2 (COST-FACIT)

    Financial toxicity will be measured using the COST-FACIT v2 tool, a 12-item, validated self-reported scale validated reflecting experiences of the prior 7-days scored 0-44 (with higher scores indicating more toxicity).

    Up to 72 weeks

Secondary Outcomes (3)

  • Medications

    Up to 72 weeks

  • Work Productivity and Activity Impairment Questionnaire v2 (WPAI)

    Up to 72 weeks

  • Out-of-pocket Healthcare Cost Questionnaire (OOP)

    Up to 72 weeks

Study Arms (1)

Caregivers

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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.

You may qualify if:

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

You may not qualify if:

  • Non-English speaking

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Baylor Scott & White Research Institute (BSW)

Dallas, Texas, 75246, United States

Location

MeSH Terms

Conditions

Liver CirrhosisHypertension, Portal

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System DiseasesFibrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Elliott Tapper, MD

    University of Michigan

    PRINCIPAL INVESTIGATOR

  • Marina Serper, MD, MS

    University of Michigan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Internal Medicine

Study Record Dates

First Submitted

August 18, 2025

First Posted

August 24, 2025

Study Start

June 13, 2023

Primary Completion

March 27, 2026

Study Completion (Estimated)

June 1, 2026

Last Updated

April 29, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations

US(3)