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Not yet recruiting NCT07741357

Kidney RISE: Randomized Integrated Supportive CarE Trial

No phase Interventional Chronic Kidney Disease (Stages 4 and 5)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Kidney RISE.
Who it may be relevant to
Registry conditions: Chronic Kidney Disease (Stages 4 and 5). Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Phase II Multi-Site Randomized Controlled Trial Testing Integrated Kidney Palliative Care Compared With Usual Chronic Kidney Disease Care (Kidney RISE)

Overview

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.

Interventions

  • Behavioral Kidney RISE
    Core components include assessment of symptoms (IPOS-Renal), illness understanding, goals of care, advance care planning, spiritual needs, and screening for health-related social needs (HRSNs) using the validated Centers for Medicare and Medicaid Services (CMS) Accountable Health Communities (AHC) Survey. Plans will address symptom management with evidence-based algorithms, linkage to social or spiritual supports, and shared decision-making appropriate to CKD stage.

Primary outcome measures

  • Change in Integrated Palliative Care Outcome Scale - Renal (IPOS-Renal) Patient Version scores [Time frame: Baseline, Week 12]
  • Change in Integrated Palliative Care Outcome Scale - Renal (IPOS-Renal) Patient Version scores [Time frame: Baseline, Week 24]
Secondary outcome measures (8)
  • Change in Kidney Disease Quality of Life 36-Item (KDQOL-36) Short-Form Survey [Time frame: Baseline, Week 12]
  • Change in Kidney Disease Quality of Life 36-Item (KDQOL-36) Short-Form Survey [Time frame: Baseline, Week 24]
  • Number of participants with advance care planning [Time frame: Week 12]
  • Number of participants with advance care planning [Time frame: Week 24]
  • Change in Patient Activation Measure-13 (PAM-13) scores [Time frame: Baseline, Week 12]
  • Change in Patient Activation Measure-13 (PAM-13) scores [Time frame: Baseline, Week 24]
  • Change in General Anxiety Disorder-7 (GAD-7) scores [Time frame: Baseline, Week 12]
  • Change in General Anxiety Disorder-7 (GAD-7) scores [Time frame: Baseline, Week 24]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.
  • Non-English and Non-Spanish speakers to correspond with the populations most impacted by CKD in the US.
  • Pregnant individuals.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Supportive care

Study locations

United States · 2 centers
  • Emory University — Atlanta
  • NYU Langone Health — New York

Identifiers

NCT: NCT07741357 · 26-00770

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗