Utilization, Health CareNCT04341896
Healthcare Utilization in Obese Caregiver Living Donors
An observational study of Utilization, Health Care and Obesity, run by University of Alabama at Birmingham at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Utilization, Health Care, Obesity
- What is being tested?
- Caregivers and Non-caregivers
- How many people
- 784 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2020to 1 Dec 2024
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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).
Who may be able to join
- 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
Who cannot join
- Age < 18 years
- Non-obese at time of donation
- Does not consent to study participation
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Alabama at Birmingham
Birmingham, Alabama, 35294
About this study
Official title: The Role of Caregiving in Healthcare Utilization Among Obese Living Kidney Donors
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.
Read the 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.
- Conditions
- Utilization, Health Care, Obesity
- Being tested
- Caregivers, Non-caregivers
- Keywords
- living kidney donor
- Medical subject headings
- Patient Acceptance of Health Care, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CaregiversOther
Individuals who cared for themselves and their transplant recipient before and after kidney donation
Non-caregiversOther
Individuals who donated a kidney as a living donor but did not serve as the primary caregiver for their recipient
| Study group | Role | What they receive |
|---|---|---|
| Caregivers | Prior obese living kidney donors who served as the primary caregiver for their recipient Receives: Other: Caregivers | |
| Non-caregivers | Prior obese living kidney donors who were not the primary caregiver for their recipient Receives: Other: Non-caregivers |
What is being measured
The primary outcome is the main question the study is designed to answer.
Emergency Department Utilization
Proportion self-reporting at least one visit to the emergency department since donation/previous questionnaire
Measured: 44 months
Hospital Admission
Proportion self-reporting at least one hospital admission since donation/previous questionnaire
Measured: 44 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2020
- Study start1 Jul 2020
- Primary completion7 Mar 2024
- Study completion1 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Utilization, Health CareStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 784 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Rhiannon Deierhoi Reed, University of Alabama at Birmingham
- Investigators
- Rhiannon Reed, DrPH, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04341896
- Sponsor's protocol ID
- IRB-300000039
- Other IDs
- P30AG031054
- Status last verified
- Feb 2025
- First submitted
- 8 Apr 2020
- Last updated
- 10 Feb 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: To be determined
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Caregiving in Healthcare Utilization Among Obese Living Kidney Donors
- ClinicalTrials.gov ID
- NCT04341896
- Acronym / sponsor ID
- IRB-300000039
- Conditions
- Utilization, Health Care, Obesity
- Keywords
- living kidney donor
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 784 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 7 Mar 2024 (actual)
- Study completion
- 1 Dec 2024 (actual)
- First posted
- 10 Apr 2020 (actual)
- Results
- Posted 10 Feb 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Caregivers | – | Other: CaregiversPrior obese living kidney donors who served as the primary caregiver for their recipient |
| Non-caregivers | – | Other: Non-caregiversPrior obese living kidney donors who were not the primary caregiver for their recipient |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- Age < 18 years
- Non-obese at time of donation
- Does not consent to study participation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CaregiversIndividuals who cared for themselves and their transplant recipient before and after kidney donation | Other | Caregivers |
| Non-caregiversIndividuals who donated a kidney as a living donor but did not serve as the primary caregiver for their recipient | Other | Non-caregivers |
Primary outcome
Emergency Department Utilization
Time frame: 44 months
Proportion self-reporting at least one visit to the emergency department since donation/previous questionnaire
Hospital Admission
Time frame: 44 months
Proportion self-reporting at least one hospital admission since donation/previous questionnaire
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. To be determined
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rhiannon Reed, DrPH principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Utilization, Health Care and Obesity, run by University of Alabama at Birmingham at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Feb 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Emergency Department Utilization (time frame: 44 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2025.