Supportive Care for Chronic Kidney Disease

Overseen By Haley Gross

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: NYU Langone Health

Disqualifiers: Recent palliative care, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

84 Participants Needed

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?

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

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

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?

Group I: Supportive Care Intervention Experimental Treatment 1 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 Control Active Control 1 Intervention

The usual care control arm will be seen at the discretion of their nephrologist, or receive their usual dialysis if on dialysis.

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+