Healthcare Utilization in Obese Caregiver Living Donors

Completed

• Conditions: Obesity; Utilization, Health Care
• Interventions: Other: Caregivers; Other: Non-caregivers

• Registration Number: NCT04341896
• Lead Sponsor: University of Alabama at Birmingham

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2020-04-08
• Study First Submitted QC: 2020-04-08
• Study First Posted: 2020-04-10
• Study Start: 2020-07-01
• Primary Completion: 2024-03-07
• Status Verified: 2024-12
• Study Completion: 2024-12-01
• Last Update Submitted: 2024-12-11
• Last Update Posted: 2024-12-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 784

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

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Caregivers	Caregivers	Prior obese living kidney donors who served as the primary caregiver for their recipient
Non-caregivers	Non-caregivers	Prior obese living kidney donors who were not the primary caregiver for their recipient

Primary Outcome Measures

Name	Time	Method
Hospital admission	Baseline (kidney donation) through 40 years	Proportion self-reporting at least one hospital admission since donation/previous questionnaire
Emergency department utilization	Baseline (kidney donation) through 40 years	Proportion self-reporting at least one visit to the emergency department since donation/previous questionnaire

Trial Locations

Locations (1)

University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States