Healthcare Utilization in Obese Caregiver Living Donors

Sponsor
University of Alabama at Birmingham (Other)
Overall Status
Recruiting
CT.gov ID
NCT04341896
Collaborator
(none)
25,352
1
29
873.9

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Caregivers
  • Other: Non-caregivers

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.

Study Design

Study Type:
Observational
Anticipated Enrollment :
25352 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
The Role of Caregiving in Healthcare Utilization Among Obese Living Kidney Donors
Actual Study Start Date :
Jul 1, 2020
Anticipated Primary Completion Date :
Nov 30, 2022
Anticipated Study Completion Date :
Dec 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Caregivers

Prior obese living kidney donors who served as the primary caregiver for their recipient

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

Non-caregivers

Prior obese living kidney donors who were not the primary caregiver for their recipient

Other: Non-caregivers
Individuals who donated a kidney as a living donor but did not serve as the primary caregiver for their recipient

Outcome Measures

Primary Outcome Measures

  1. Emergency department utilization [Baseline (kidney donation) through 40 years]

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

  2. Hospital admission [Baseline (kidney donation) through 40 years]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Alabama at Birmingham Birmingham Alabama United States 35294

Sponsors and Collaborators

  • University of Alabama at Birmingham

Investigators

  • Principal Investigator: Rhiannon Reed, DrPH, University of Alabama at Birmingham

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Rhiannon Deierhoi Reed, Principal Investigator, University of Alabama at Birmingham
ClinicalTrials.gov Identifier:
NCT04341896
Other Study ID Numbers:
  • IRB-300000039
First Posted:
Apr 10, 2020
Last Update Posted:
Jun 24, 2022
Last Verified:
Jun 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Rhiannon Deierhoi Reed, Principal Investigator, University of Alabama at Birmingham

Study Results

No Results Posted as of Jun 24, 2022