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Supportive Care for Chronic Kidney Disease
N/A
Recruiting
Led By Jennifer Scherer, MD
Research Sponsored by NYU Langone Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Documented diagnosis of Chronic Kidney Disease stage IV or V
Age ≥ 18
Timeline
Screening 3 weeks
Treatment Varies
Follow Up month 24
Awards & highlights
Study Summary
This trial tests whether integrated care visits improve symptoms, quality of life, and advance care planning for patients with advanced CKD.
Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Since this intervention involves additional supportive care rather than medication, typical drug side effects aren't expected. However, participants may experience emotional discomfort discussing advance care planning.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My condition is chronic kidney disease at stage IV or V.
Select...
I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ month 24
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~month 24
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Ability to Collect Planned Data
Average number of clinical visits attended per participant (Retention)
Change in Integrated Palliative Outcome Score-Renal (IPOS-Renal) Score
+3 moreSecondary outcome measures
Change in Kidney Disease Quality of Life (KDQOL-36) Score
Engagement in Advance Care Planning
Trial Design
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.
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Who is running the clinical trial?
NYU Langone HealthLead Sponsor
1,368 Previous Clinical Trials
839,646 Total Patients Enrolled
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,358 Previous Clinical Trials
4,315,161 Total Patients Enrolled
Jennifer Scherer, MDPrincipal InvestigatorNYU Langone Health
1 Previous Clinical Trials
45 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have received care to ease symptoms in the last 6 months.I am willing and able to follow the study rules and attend all appointments.I need urgent care for my symptoms.My condition is chronic kidney disease at stage IV or V.I am not fluent in English or Spanish.I am 18 years old or older.I speak Spanish or English fluently.
Research Study Groups:
This trial has the following groups:- Group 1: Supportive Care Intervention
- Group 2: Usual Care Control
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are any additional participants being sought for this clinical trial?
"According to the clinicaltrials.gov listing, this medical study is still in search of volunteers. The trial was originally listed on May 1st 2022 and most recently updated by February 23rd 2022."
Answered by AI
What is the enrollment count for this clinical trial?
"Indeed, the details on clinicaltrials.gov verify that this trial is presently engaging candidates. It was initially posted on 5th January 2022 and has been revised to its current form as of 23rd February 2022. The medical study demands 80 subjects from one centre."
Answered by AI
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