Kidney RISE: Randomized Integrated Supportive CarE Trial

Part of paid clinical trials in Atlanta, Georgia.

Sponsor
NYU Langone Health
Study ID
NCT07741357
Status
Not Yet Recruiting

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Conditions

  • Chronic Kidney Disease (Stages 4 and 5)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Kidney RISE — BEHAVIORAL
    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.

Study Details

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.

Key Dates

First listed
Aug 3, 2026
Start date
May 31, 2027
Status verified
Jul 2026
Primary completion
Aug 31, 2030
Completion
Jan 31, 2031

Study Design

Enrollment
280 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Integrated Kidney Palliative Care
    Participants will receive integrated kidney palliative care (Kidney RISE) in addition to their usual CKD care. The integrated kidney palliative care consists of 4 kidney palliative care (KPC) intervention visits over 24 weeks by a KPC-trained palliative care provider in person or telehealth, each visit will last between 30-60 minutes.
  • No Intervention: Usual Chronic Kidney Disease (CKD) Care
    Participants in this arm will receive the usual CKD care.

Primary Outcome Measure

Change in Integrated Palliative Care Outcome Scale - Renal (IPOS-Renal) Patient Version scores [ Time Frame: Baseline, Week 12 ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Emory UniversityAtlantaGeorgia30322
Dio Kavalieratos, MD (PRINCIPAL_INVESTIGATOR)
NYU Langone HealthNew YorkNew York10016
Jennifer Scherer, MD, MS, FASN (PRINCIPAL_INVESTIGATOR)

Find similar trials in Atlanta, GA

By research site
Emory University· Atlanta, GANYU Langone Health· New York, NY

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