An interventional study of Offering SARS-CoV-2 test in End-stage Renal Disease, SARS-CoV-2 Acute Respiratory Disease and Dialysis; Complications, sponsored by Stanford University. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-10-30.
Sponsored by Stanford University · Not applicable, Interventional, and Screening
Patients receiving dialysis are one of the highest risk groups for serious illness with SARS-CoV-2 infection. In addition to the inherent risks of travel to and dialysis within indoor facilities, patients receiving dialysis are more likely to be older, non-white, from disadvantaged backgrounds, and have impaired immune responses to viral infections and vaccinations. Universal testing offered at hemodialysis facilities could shield this vulnerable population from exposure, enable early identification and treatment for those affected, and reduce transmission to other patients and family members. In this pragmatic cluster randomized controlled trial as part of NIH RADx-UP Consortium, we will randomize 62 US Renal Care facilities with an estimated 2480 patients to static versus dynamic universal screening testing strategies. Static universal screening will involve offering patients SARS-CoV-2 screening tests every two weeks; the dynamic universal screening strategy will vary the frequency of testing from once every week to once every four weeks, depending on community COVID-19 case rates. We hypothesize that patients dialyzing at facilities randomized to a dynamic testing frequency responsive to community case rates will have higher test acceptability (primary outcome), experience lower rates of COVID-19 death and hospitalization, and report better experience-of-care metrics.
2,121 studies on the registry are indexed under Kidney Failure, Chronic; 264 are open to participants now.
This study's enrollment of 2,389 is above the median of 55 across 1,582 interventional studies indexed under Kidney Failure, Chronic.
Browse Kidney Failure, Chronic studies →Stanford University is the lead sponsor of 2,161 studies on the registry; 428 are open to participants now.
Of its 268 completed or terminated interventional studies of FDA-regulated products, 207 (77%) have results posted.
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Facility
Exclusion Criteria:
Patient
Test based screening for SARS-CoV-2 every two weeks
Behavioral: Offering SARS-CoV-2 test
Test based screening for SARS-CoV-2 ranging from once a week to once every four weeks anchored to county COVID-19 case rates
Behavioral: Offering SARS-CoV-2 test
A pragmatic cluster (facility-level) randomized clinical trial, comparing test-based screening performed at a static (every two weeks) frequency versus a dynamic frequency (ranging from once a week to once every four weeks) anchored to county COVID-19 case rates
Number and Percentage of Total SARS-CoV-2 Tests Accepted Out of Total Tests Offered
Time frame: 3 months
Deaths
Time frame: 4 months
Hospitalizations
Time frame: 4 months
Change in Facility Scores on In-Center Hemodialysis Consumer Assessment of Healthcare Providers and Systems (ICH CAHPS) Survey
this survey is administered annually at each dialysis facility dialysis facility (based on Centers for Medicare Services regulation)
Time frame: 4 months
Patients were offered tests over a period of 3 months then entered a 1-month follow-up period.
| Milestone | Static Frequency | Dynamic Frequency |
|---|---|---|
| Started | 1069 | 1320 |
| Completed | 1069 | 1320 |
| Not completed | 0 | 0 |
| Tests | Static Frequency | Dynamic Frequency |
|---|---|---|
| Number and Percentage of Total SARS-CoV-2 Tests Accepted Out of Total Tests Offered | 509 | 475 |
| Participants | Static Frequency | Dynamic Frequency |
|---|---|---|
| Deaths | 31 | 41 |
| Participants | Static Frequency | Dynamic Frequency |
|---|---|---|
| Hospitalizations | 310 | 444 |
this survey is administered annually at each dialysis facility dialysis facility (based on Centers for Medicare Services regulation)
No measurements were reported for this outcome.
Collected over 4 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Static Frequency | 31/1,069 (2.9%) | — | — |
| Dynamic Frequency | 41/1,320 (3.1%) | — | — |
| Age, Continuous(years) | Static Frequency | Dynamic Frequency | Total |
|---|---|---|---|
| Median | 63 (54 to 73) | 65 (54 to 74) | 64 (54 to 74) |
| Sex: Female, Male(Participants) | Static Frequency | Dynamic Frequency | Total |
|---|---|---|---|
| Female | 478 | 570 | 1048 |
| Male | 591 | 750 | 1341 |
| Race/Ethnicity, Customized(Participants) | Static Frequency | Dynamic Frequency | Total |
|---|---|---|---|
| Hispanic | 165 | 173 | 338 |
| American Indian | 72 | 66 | 138 |
| Asian | 26 | 34 | 60 |
| Black | 395 | 490 | 885 |
| Native Hawaiian or Pacific Islander | 26 | 49 | 75 |
| White | 381 | 495 | 876 |
| Missing | 4 | 13 | 17 |
| Region of Enrollment(Participants) | Static Frequency | Dynamic Frequency | Total |
|---|---|---|---|
| United States | 1069 | 1320 | 2389 |
| Diabetes(Participants) | Static Frequency | Dynamic Frequency | Total |
|---|---|---|---|
| Count of participants | 720 | 883 | 1603 |
| Facility Region(Facilities) | Static Frequency | Dynamic Frequency | Total |
|---|---|---|---|
| Northeast | 4 | 4 | 8 |
| Midwest | 5 | 5 | 10 |
| South | 13 | 14 | 27 |
| West | 6 | 6 | 12 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — Anonymized data will be shared with NIH Radx-UP data repository.
Supporting information: Study protocol, Statistical analysis plan, Clinical study report
This study is completed, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.
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