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)

What You Need to Know Before You Apply

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.

Who Is on the Research Team?

JS

Jennifer Scherer, MD

Principal Investigator

NYU Langone Health

Are You a Good Fit for This Trial?

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
See 1 more

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
See 1 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive integrated ambulatory supportive care visits with standard nephrology outpatient visits

6 months
Monthly visits

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

What Are the Treatments Tested in This Trial?

Interventions

  • Integrated Palliative Care
Trial Overview The 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.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: Supportive Care InterventionExperimental Treatment1 Intervention
Group II: Usual Care ControlActive Control1 Intervention

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+
Unbiased ResultsWe believe in providing patients with all the options.
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