Trial Outcomes & Findings for Healthcare Utilization in Obese Caregiver Living Donors (NCT NCT04341896)
NCT ID: NCT04341896
Last Updated: 2025-02-10
Results Overview
Proportion self-reporting at least one visit to the emergency department since donation/previous questionnaire
Recruitment status
COMPLETED
Target enrollment
784 participants
Primary outcome timeframe
44 months
Results posted on
2025-02-10
Participant Flow
Participant milestones
| Measure |
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
|
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
|
|---|---|---|
|
Overall Study
STARTED
|
148
|
636
|
|
Overall Study
COMPLETED
|
148
|
636
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Healthcare Utilization in Obese Caregiver Living Donors
Baseline characteristics by cohort
| Measure |
Caregivers
n=148 Participants
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
|
Non-caregivers
n=636 Participants
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
|
Total
n=784 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
49.1 Years
n=99 Participants
|
46.5 Years
n=107 Participants
|
47.2 Years
n=206 Participants
|
|
Sex: Female, Male
Female
|
103 Participants
n=99 Participants
|
371 Participants
n=107 Participants
|
474 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
45 Participants
n=99 Participants
|
265 Participants
n=107 Participants
|
310 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
16 Participants
n=99 Participants
|
64 Participants
n=107 Participants
|
80 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
124 Participants
n=99 Participants
|
529 Participants
n=107 Participants
|
653 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=99 Participants
|
27 Participants
n=107 Participants
|
30 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Relationship to recipient
Parent
|
24 Participants
n=99 Participants
|
29 Participants
n=107 Participants
|
53 Participants
n=206 Participants
|
|
Relationship to recipient
Spouse/partner
|
74 Participants
n=99 Participants
|
50 Participants
n=107 Participants
|
124 Participants
n=206 Participants
|
|
Relationship to recipient
Child
|
14 Participants
n=99 Participants
|
76 Participants
n=107 Participants
|
90 Participants
n=206 Participants
|
|
Relationship to recipient
Sibling
|
19 Participants
n=99 Participants
|
163 Participants
n=107 Participants
|
182 Participants
n=206 Participants
|
|
Relationship to recipient
Other biologic
|
3 Participants
n=99 Participants
|
69 Participants
n=107 Participants
|
72 Participants
n=206 Participants
|
|
Relationship to recipient
Non-biologic
|
14 Participants
n=99 Participants
|
249 Participants
n=107 Participants
|
263 Participants
n=206 Participants
|
|
Working for income
Part-time
|
11 Participants
n=99 Participants
|
50 Participants
n=107 Participants
|
61 Participants
n=206 Participants
|
|
Working for income
Full-time
|
66 Participants
n=99 Participants
|
383 Participants
n=107 Participants
|
449 Participants
n=206 Participants
|
|
Working for income
Unemployed
|
13 Participants
n=99 Participants
|
43 Participants
n=107 Participants
|
56 Participants
n=206 Participants
|
|
Working for income
Retired
|
56 Participants
n=99 Participants
|
158 Participants
n=107 Participants
|
214 Participants
n=206 Participants
|
|
Working for income
Unknown
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Marital status
Single
|
31 Participants
n=99 Participants
|
101 Participants
n=107 Participants
|
132 Participants
n=206 Participants
|
|
Marital status
Married
|
86 Participants
n=99 Participants
|
435 Participants
n=107 Participants
|
521 Participants
n=206 Participants
|
|
Marital status
Co-habitating
|
6 Participants
n=99 Participants
|
20 Participants
n=107 Participants
|
26 Participants
n=206 Participants
|
|
Marital status
Divorced
|
14 Participants
n=99 Participants
|
66 Participants
n=107 Participants
|
80 Participants
n=206 Participants
|
|
Marital status
Unknown
|
11 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
25 Participants
n=206 Participants
|
|
Time since donation
|
11.8 Years
n=99 Participants
|
10.3 Years
n=107 Participants
|
10.4 Years
n=206 Participants
|
PRIMARY outcome
Timeframe: 44 monthsPopulation: The denominator for this outcome is based on participants who responded to the survey item asking about emergency department utilization since donation
Proportion self-reporting at least one visit to the emergency department since donation/previous questionnaire
Outcome measures
| Measure |
Caregivers
n=144 Participants
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
|
Non-caregivers
n=618 Participants
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
|
|---|---|---|
|
Emergency Department Utilization
|
77 Participants
|
305 Participants
|
PRIMARY outcome
Timeframe: 44 monthsPopulation: The denominator is from participants who responded to the survey question regarding hospitalization since donation.
Proportion self-reporting at least one hospital admission since donation/previous questionnaire
Outcome measures
| Measure |
Caregivers
n=138 Participants
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
|
Non-caregivers
n=588 Participants
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
|
|---|---|---|
|
Hospital Admission
|
71 Participants
|
237 Participants
|
Adverse Events
Caregivers
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Non-caregivers
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place