Kidney RISE: Randomized Integrated Supportive CarE Trial
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorNYU Langone Health
About this trial
The purpose of study is to investigate whether adding palliative care to usual chronic kidney disease (CKD) care improves symptoms and quality of life for people with CKD. The primary objectives are to 1) determine efficacy of Kidney Palliative Care (KPC) integrated with CKD care on symptom burden compared with usual CKD care, 2) identify clinical and demographic factors associated with differential responses to KPC, and 3) characterize participant and provider experiences with kidney care and factors influencing implementation.
Eligibility criteria
Qualifiers
Receive care at nephrology clinics or dialysis centers associated with each site.
Have CKD stage IV, V (eGFR < 30 mL/min/1.73m2), or be receiving chronic dialysis
Speak Spanish or English, and report at IPOS-Renal score of ≥ 3 on a screening survey.
Willing to be randomized to either study arm and to comply with the study procedures for the assigned group.
Disqualifiers
Unable to provide informed consent
Has received palliative care (inpatient or outpatient) in the last six months.
Enrolled in hospice
Has any urgent palliative care needs (i.e. severe pain, emotional distress) identified upon screening. Research staff will be trained to recognize these needs.
Trial design
Treatments tested in this trial
- Kidney RISE
Treatment groups
280 Participants
are divided into 2 treatment groupsSponsors and collaborators
NYU Langone Health
Lead sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator
Source ClinicalTrials.gov