Healthcare Utilization in Obese Caregiver Living Donors

NCT04341896 | Completed Results

• 2 other identifiers: IRB-300000039P30AG031054
• Study Type: observational
• Target: 784
• Locations: 1 country
• Sites: 1

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.

Conditions

Utilization, Health Care; Obesity

Keywords

living kidney donor

Outcome Measures

Primary Outcomes (2)

• Emergency Department Utilization

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

  44 months

• Hospital Admission

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

  44 months

Study Arms (2)

Caregivers

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

Other: Caregivers

Non-caregivers

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

Other: Non-caregivers

Interventions

Caregivers OTHER

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

Caregivers

Non-caregivers OTHER

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

Non-caregivers

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This study is an ancillary study to 1R01DK113980, a retrospective cohort study that is assembling the largest cohort of previous living kidney donors with obesity from 1968-present from all centers across the US. The parent R01 is projected to enroll approximately 25,000 obese living donors, and 20% (n=5,070) of these are estimated to have served as the primary caregiver for their transplant recipient (the primary exposure of this study).

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Alabama at Birmingham: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

MeSH Terms

Conditions

Patient Acceptance of Health Care; Obesity

Interventions

Caregivers

Condition Hierarchy (Ancestors)

Treatment Adherence and Compliance; Health Behavior; Behavior; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Health Personnel; Health Care Facilities Workforce and Services

Results Point of Contact

• Title: Rhiannon Reed
• Organization: New York University

rjd1125@uab.edu

205-999-3360

Study Officials

• Rhiannon Reed, DrPH

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 8, 2020
• First Posted: April 10, 2020
• Study Start: July 1, 2020
• Primary Completion: March 7, 2024
• Study Completion: December 1, 2024
• Last Updated: February 10, 2025
• Results First Posted: February 10, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)