Beta-blockers or Placebo for Primary Prophylaxis (BOPPP) of Oesophageal Varices Trial.
NCT05872698
Cirrhosis, Liver, Digestive System Diseases
London, United Kingdom
View Trial DetailsNCT Number: NCT07140120
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.
This study is active but is not currently recruiting participants.
Notify Me18 year and older
All sexes
Observational
University of Michigan, Ann Arbor, Michigan, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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).
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.
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.
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).
University of Michigan
Other
LiveSMART: A Sequential, Multiple Assignment Randomized Trial to Prevent Falls in Patients With Cirrhosis - Observational Study
Acronym: LiveSMART
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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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