84 Participants Needed

Supportive Care for Chronic Kidney Disease

PK
JS
AM
HG
Overseen ByHaley Gross
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: NYU Langone Health
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

What is the purpose of this trial?

This study is a pilot randomized controlled trial testing the effectiveness of integrated ambulatory supportive care visits with standard nephrology outpatient visits for six months in patients with advanced CKD. The study team hypothesizes that patients in the integrated care arm will trend towards improved symptom burden, improved quality of life scores and more engagement in advance care planning. Primary objectives: To test the impact of integrated ambulatory supportive care in nephrology care on symptom burden. Secondary: To test the impact of integrated ambulatory supportive care on quality of life and engagement in advance care planning and to demonstrate study feasibility.

Research Team

JS

Jennifer Scherer, MD

Principal Investigator

NYU Langone Health

Eligibility Criteria

This trial is for adults over 18 with advanced Chronic Kidney Disease (stage IV or V), including those on dialysis, who speak English or Spanish fluently. They must consent to participate and commit to the study's procedures for six months. People who've had palliative care recently, are pregnant, have urgent palliative needs, or can't understand the study due to cognitive issues cannot join.

Inclusion Criteria

I am willing and able to follow the study rules and attend all appointments.
My condition is chronic kidney disease at stage IV or V.
Provision of signed and dated informed consent form
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Exclusion Criteria

I have received care to ease symptoms in the last 6 months.
I need urgent care for my symptoms.
Presence of a condition(s) or diagnosis, either physical or psychological, or physical exam finding that precludes participation, for example not being able to cognitively understand the questions or to provide informed consent
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Treatment Details

Interventions

  • Integrated Palliative Care
Trial OverviewThe trial tests if adding supportive care visits to regular kidney disease outpatient appointments helps reduce symptoms and improve quality of life over six months. It also looks at whether this integrated approach increases engagement in planning future medical care.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: Supportive Care InterventionExperimental Treatment1 Intervention
The supportive care intervention arm will receive their usual ambulatory longitudinal nephrology care integrated with ambulatory supportive care through monthly supportive care visits over six months.
Group II: Usual Care ControlActive Control1 Intervention
The usual care control arm will be seen at the discretion of their nephrologist, or receive their usual dialysis if on dialysis.

Find a Clinic Near You

Who Is Running the Clinical Trial?

NYU Langone Health

Lead Sponsor

Trials
1,431
Recruited
838,000+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials
2,513
Recruited
4,366,000+