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

NCT ID: NCT07140120

Last Updated: 2025-08-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

52 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-06-13

Study Completion Date

2026-03-31

Brief Summary

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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

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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

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Cirrhosis, Liver Portal Hypertension

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Patient-Centered Outcomes Research Institute

OTHER

Sponsor Role collaborator

University of Michigan

OTHER

Sponsor Role lead

Responsible Party

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Elliot B. Tapper

Associate Professor of Internal Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Elliott Tapper, MD

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Marina Serper, MD, MS

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Locations

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University of Michigan

Ann Arbor, Michigan, United States

Site Status

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status

Baylor Scott & White Research Institute (BSW)

Dallas, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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CER-2021C3-24907

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

HUM00225275-B

Identifier Type: -

Identifier Source: org_study_id

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