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Healthcare Utilization in Obese Caregiver Living Donors

The Role of Caregiving in Healthcare Utilization Among Obese Living Kidney Donors

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04341896
Enrollment
784
Registered
2020-04-10
Start date
2020-07-01
Completion date
2024-12-01
Last updated
2025-02-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity, Utilization, Health Care

Keywords

living kidney donor

Brief 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.

Detailed 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.

Interventions

OTHERCaregivers

Individuals who cared for themselves and their transplant recipient before and after kidney donation

OTHERNon-caregivers

Individuals who donated a kidney as a living donor but did not serve as the primary caregiver for their recipient

Sponsors

National Institute on Aging (NIA)
CollaboratorNIH
University of Alabama at Birmingham
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Age 18 years or greater * Underwent living donor nephrectomy at a transplant center in the United States between 1968 to present * Obesity: had a body mass index of 30 kg/m2 or greater at time of kidney donation

Exclusion criteria

* Age \< 18 years * Non-obese at time of donation * Does not consent to study participation

Design outcomes

Primary

MeasureTime frameDescription
Emergency Department Utilization44 monthsProportion self-reporting at least one visit to the emergency department since donation/previous questionnaire
Hospital Admission44 monthsProportion self-reporting at least one hospital admission since donation/previous questionnaire

Countries

United States

Participant flow

Participants by arm

ArmCount
Caregivers
Prior obese living kidney donors who served as the primary caregiver for their recipient Caregivers: Individuals who cared for themselves and their transplant recipient before and after kidney donation
148
Non-caregivers
Prior obese living kidney donors who were not the primary caregiver for their recipient Non-caregivers: Individuals who donated a kidney as a living donor but did not serve as the primary caregiver for their recipient
636
Total784

Baseline characteristics

CharacteristicTotalNon-caregiversCaregivers
Age, Continuous47.2 Years46.5 Years49.1 Years
Marital status
Co-habitating
26 Participants20 Participants6 Participants
Marital status
Divorced
80 Participants66 Participants14 Participants
Marital status
Married
521 Participants435 Participants86 Participants
Marital status
Single
132 Participants101 Participants31 Participants
Marital status
Unknown
25 Participants14 Participants11 Participants
Race (NIH/OMB)
American Indian or Alaska Native
5 Participants4 Participants1 Participants
Race (NIH/OMB)
Asian
13 Participants10 Participants3 Participants
Race (NIH/OMB)
Black or African American
80 Participants64 Participants16 Participants
Race (NIH/OMB)
More than one race
30 Participants27 Participants3 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
3 Participants2 Participants1 Participants
Race (NIH/OMB)
White
653 Participants529 Participants124 Participants
Relationship to recipient
Child
90 Participants76 Participants14 Participants
Relationship to recipient
Non-biologic
263 Participants249 Participants14 Participants
Relationship to recipient
Other biologic
72 Participants69 Participants3 Participants
Relationship to recipient
Parent
53 Participants29 Participants24 Participants
Relationship to recipient
Sibling
182 Participants163 Participants19 Participants
Relationship to recipient
Spouse/partner
124 Participants50 Participants74 Participants
Sex: Female, Male
Female
474 Participants371 Participants103 Participants
Sex: Female, Male
Male
310 Participants265 Participants45 Participants
Time since donation10.4 Years10.3 Years11.8 Years
Working for income
Full-time
449 Participants383 Participants66 Participants
Working for income
Part-time
61 Participants50 Participants11 Participants
Working for income
Retired
214 Participants158 Participants56 Participants
Working for income
Unemployed
56 Participants43 Participants13 Participants
Working for income
Unknown
4 Participants2 Participants2 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 1480 / 636
other
Total, other adverse events
0 / 1480 / 636
serious
Total, serious adverse events
0 / 1480 / 636

Outcome results

Primary

Emergency Department Utilization

Proportion self-reporting at least one visit to the emergency department since donation/previous questionnaire

Time frame: 44 months

Population: The denominator for this outcome is based on participants who responded to the survey item asking about emergency department utilization since donation

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
CaregiversEmergency Department Utilization77 Participants
Non-caregiversEmergency Department Utilization305 Participants
Primary

Hospital Admission

Proportion self-reporting at least one hospital admission since donation/previous questionnaire

Time frame: 44 months

Population: The denominator is from participants who responded to the survey question regarding hospitalization since donation.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
CaregiversHospital Admission71 Participants
Non-caregiversHospital Admission237 Participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026