Cirrhosis, LiverLiveSMARTNCT07140120
LiveSMART Trial to Prevent Falls in Patients With Cirrhosis - Supplementary Study
An observational study of Cirrhosis, Liver and Portal Hypertension, run by University of Michigan at 3 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cirrhosis, Liver, Portal Hypertension
- How many people
- 52 participants
- Where
- 3 sitesUnited States
- Study dates
- 13 Jun 2023to Oct 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- Adult 18 years of age or older
- Informal caregiver of a participant enrolled in LIVE-SMART
- English speaking
Who cannot join
- Non-English speaking
Trial locations and contacts
3 sites in 1 country.
United States3 sites
University of Michigan
Ann Arbor, Michigan, 48109
Baylor Scott & White Research Institute (BSW)
Dallas, Texas, 75246
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: LiveSMART: A Sequential, Multiple Assignment Randomized Trial to Prevent Falls in Patients With Cirrhosis - Observational 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.
Read the 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.
- Conditions
- Cirrhosis, Liver, Portal Hypertension
- Keywords
- Exercise program, Lactulose, Tai-Chi, Fall prevention, Dietary Protein
- Medical subject headings
- Liver Cirrhosis, Hypertension, Portal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Up to 72 weeks
Secondary outcomes (3)
Medications
Current medications will be recorded at baseline. Changes and/or additions in medications will be recorded at certain follow-up visits.
Measured: Up to 72 weeks
Work Productivity and Activity Impairment Questionnaire v2 (WPAI)
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.
Measured: Up to 72 weeks
Out-of-pocket Healthcare Cost Questionnaire (OOP)
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).
Measured: Up to 72 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2025
- Study start13 Jun 2023
- Primary completion27 Mar 2026
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cirrhosis, LiverStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Responsible party
- Principal investigator, Elliot B. Tapper, University of Michigan
- Investigators
- Elliott Tapper, MD, Principal investigator, University of MichiganMarina Serper, MD, MS, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07140120
- Sponsor's protocol ID
- HUM00225275-B
- Other IDs
- CER-2021C3-24907
- Acronym
- LiveSMART
- Status last verified
- Jul 2026
- First submitted
- 18 Aug 2025
- Last updated
- 22 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- LiveSMART: A Sequential, Multiple Assignment Randomized Trial to Prevent Falls in Patients With Cirrhosis - Observational Study
- ClinicalTrials.gov ID
- NCT07140120
- Acronym / sponsor ID
- LiveSMART / HUM00225275-B
- Conditions
- Cirrhosis, Liver, Portal Hypertension
- Keywords
- Exercise program, Lactulose, Tai-Chi, Fall prevention, Dietary Protein
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 52 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Study start
- 13 Jun 2023 (actual)
- Primary completion
- 27 Mar 2026 (actual)
- Study completion
- Oct 2026 (estimated)
- First posted
- 24 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- Adult 18 years of age or older
- Informal caregiver of a participant enrolled in LIVE-SMART
- English speaking
Key exclusion criteria (1 listed)
- Non-English speaking
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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).
3 secondary outcomes
Medications
Time frame: Up to 72 weeks
Work Productivity and Activity Impairment Questionnaire v2 (WPAI)
Time frame: Up to 72 weeks
Out-of-pocket Healthcare Cost Questionnaire (OOP)
Time frame: Up to 72 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elliott Tapper, MD principal investigator
University of Michigan
Marina Serper, MD, MS principal investigator
University of Michigan
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cirrhosis, Liver and Portal Hypertension, run by University of Michigan at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 22 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comprehensive Score for Financial Toxicity - Functional Assessment of Chronic Illness Therapy v2 (COST-FACIT) (time frame: Up to 72 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2026.