Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 10:17 PM
Ignite Modification Date:
2025-12-26 @ 10:17 PM
NCT ID:
NCT02405312
Eligibility Criteria:
Inclusion Criteria:
* High-risk patients, as defined by falling within the high-risk category of our validated prognostic instrument and have approximately 50% 18-month mortality.
* English- and Spanish-speaking patients will be included (estimated to be 95% of this population).
* Patients who receive hemodialysis at one of our 16 research dialysis sites during the data collection period.
* Patients must be willing and able to sign the consent form.
* Patients who are lack the capacity to meaningfully participate in medical decisions must have a surrogate who is willing to sign the informed consent.
Exclusion Criteria:
* Children 18 years of age. Children constitute 2% of the dialysis population, and our preliminary survey of the study sites found no children were active patients. In any case, the renal and other physical factors of children with ESRD are not directly comparable to those of adults.
* Does not belong to the population's high-mortality risk quintile according to our prognostic instrument
* Severe psychiatric disorders including schizophrenia, bipolar disorder which would interfere with participation in the study (severity determined by psychiatric hospitalization in the past month or actively suicidal)
* Active substance abuse (active abuse is defined as using alcohol or recreational drugs in the past 30 days in a way that interferes with their ability to function in daily life)
* Expectation of native kidney recovery
* History of poor adherence to thrice-weekly hemodialysis (poor adherence defined by missing 4 treatments in the past month)
* Unable to communicate in English or Spanish
* Scheduled for living donor kidney transplant, conversion to peritoneal dialysis, or plans to relocate to another hemodialysis unit
* Current pregnancy or actively planning to become pregnant
* Currently a prisoner
* Unable or unwilling to follow the study protocol
* Unable or unwilling to provide informed consent or sign Institutional Review Board (IRB)-approval or lack of a surrogate/proxy
* Exclusion by primary nephrologist or social worker due to risk of harm
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02405312
Study Brief:
Protocol Section:
NCT02405312