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NCT Number: NCT07140120

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Michigan, Ann Arbor, Michigan, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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

    Time frame: Up to 72 weeks

    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).

Secondary outcomes

  1. Medications

    Time frame: Up to 72 weeks

    Current medications will be recorded at baseline. Changes and/or additions in medications will be recorded at certain follow-up visits.

  2. Work Productivity and Activity Impairment Questionnaire v2 (WPAI)

    Time frame: Up to 72 weeks

    The WPAI will be used to assess caregivers who report employment, work productivity, absenteeism and presenteeism. Absenteeism is the proportion of work hours lost due to caregiving for someone with cirrhosis subtracted from the total planned work hours in one week before completing the questionnaire. Presenteeism is the proportion of hours worked from the total planned work hours multiplied by the participants impairment in productivity while working (a self-assessed Likert scale from 0 to 10 with 10 indicating complete inability to work). The total work productivity impairment (WPI) is the sum of these two per cent components, ranging from 0 to 100% with 0% indicating no impairment and 100% indicating worst possible impairment. In order to aggregate, productivity loss will be multiplied by the average wage inflated to 2023 dollars.

  3. Out-of-pocket Healthcare Cost Questionnaire (OOP)

    Time frame: Up to 72 weeks

    The OOP questionnaire combines questions from two assessments - Client Service Receipt Inventory (CSRI) and questions pulled from the Healthy Retirement Survey (HRS). Costs will be measured at the household-level using items from the CSRI. Out-of-pocket costs associated with insurance premiums, hospitalizations/ED visits, outpatient surgeries/procedures, clinic visits, skilled nursing facility /rehabilitation stays, prescriptions, dental care, in-home medical care, and any additional medical expenses or healthcare services will be assessed. The cost of hours of caregiving will be calculated by converting the reported hours of informal care provided in the month prior to each interview to a five-year total number of hours. In order to aggregate, replacement costs will be calculated by multiplying the hours by average costs of home health care services inflated to 2023 dollars (e.g., $28/hour).

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Collaborators

  • Patient-Centered Outcomes Research Institute

Registry information

Official study title

LiveSMART: A Sequential, Multiple Assignment Randomized Trial to Prevent Falls in Patients With Cirrhosis - Observational Study

Acronym: LiveSMART

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Aug 24, 2025
Registry last updated
Jul 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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