Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT04341896 |
| Other study ID # |
IRB-300000039 |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
July 1, 2020 |
| Est. completion date |
December 1, 2024 |
Study information
| Verified date |
March 2024 |
| Source |
University of Alabama at Birmingham |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
The goal of this study is to estimate risk of post-donation healthcare use attributable to
informal caregiving among obese living donors. Improving our understanding of the
relationship between caregiving, donation, and healthcare use will allow us to improve living
donor informed consent and post-donation care, particularly among older donors and those of
minority race/ethnicity.
Description:
Caregiver burden is a well-known issue of primary caregiving for individuals with chronic
disease, including transplant candidates and recipients. Informal caregiving is associated
with an estimated $306 billion in unpaid labor costs and an average of $7,000 in
out-of-pocket expenses related to the caregiving role. In addition to financial burdens,
caregivers experience psychological distress and adverse health outcomes, including higher
rates of hypertension and heart disease. These burdens differ by caregiver ethnicity, age,
and rurality. Ethnic minority caregivers have reported more depression, lower use of support
services, and worse physical health than Whites. African American caregivers report lower
levels of depression but worse physical health. Caregiver age also plays a role in physical
health burden, with older caregiver age shown to be negatively associated with caregiver
physical functioning, bodily pain, vitality, and general health perception. This association
is directly relevant to living kidney donation, as the prevalence of donors who are 65 years
or older has increased from < 1% in 1998 to 5.6% in 2019 (based on OPTN data as of
3/23/2020). Rural caregivers report greater financial burden than their urban counterparts,
of particular concern in the Deep South, where nearly two-thirds of all counties are rural.
When caregivers have their own underlying health issues, such as obesity, burdens may be
further magnified when the caregiver becomes a patient, simultaneously requiring their own
care while caring for another (e.g. obese living kidney donors who are the primary caregiver
for their transplant recipient). Approximately 20% of living kidney donors are parents and
significant others, individuals who often serve as the recipient's primary caregiver.
Moreover, obese donors are at higher risk of post-donation disease development, including
end-stage renal disease, diabetes, and hypertension. As donor selection criteria have
expanded to include more obese individuals, these burdens impact high volume transplant
centers in the Deep South that serve largely minority and rural populations. Comorbidity,
such as obesity, in caregiver donors may increase the need for healthcare utilization,
further exacerbating financial burdens, interfering with caregiver responsibilities, and
subsequently impacting the recipient's health outcomes. To date, it is unknown whether the
burdens of being an obese caregiver living donor are associated with healthcare utilization
post-donation compared to non-caregivers and whether donor age, race, and rurality modify
this relationship. This study is ancillary to an NIH-funded retrospective cohort study of
living kidney donors with obesity (1R01DK113980) and will leverage the infrastructure of this
R01 to explore the primary exposure of caregiving within this cohort.
