Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
84 participants
INTERVENTIONAL
2022-01-05
2025-04-17
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
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Supportive Care 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.
Ambulatory Supportive Care
Ambulatory supportive care visits monthly for six months - a monthly visit with an ambulatory palliative care provider educated in kidney disease
Usual Care Control
The usual care control arm will be seen at the discretion of their nephrologist, or receive their usual dialysis if on dialysis.
No interventions assigned to this group
Interventions
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Ambulatory Supportive Care
Ambulatory supportive care visits monthly for six months - a monthly visit with an ambulatory palliative care provider educated in kidney disease
Eligibility Criteria
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Inclusion Criteria
2. Documented diagnosis of Chronic Kidney Disease stage IV or V
3. Speaks Spanish or English fluently
4. Provision of signed and dated informed consent form
5. Stated willingness to comply with all study procedures and lifestyle considerations and availability for the duration of the study.
Exclusion Criteria
2. 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.
3. Pregnant women.
4. Not fluent in either English or Spanish
5. Any urgent supportive/palliative care needs identified on screening interview.
18 Years
ALL
No
Sponsors
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National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NIH
NYU Langone Health
OTHER
Responsible Party
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Principal Investigators
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Jennifer Scherer, MD
Role: PRINCIPAL_INVESTIGATOR
NYU Langone Health
Locations
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NYC Health + Hospitals / Bellevue
New York, New York, United States
Countries
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References
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Scherer JS, Wu W, Lyu C, Goldfeld KS, Brody AA, Chodosh J, Charytan D. A pilot randomized controlled study of integrated kidney palliative care and chronic kidney disease care implemented in a safety-net hospital: Protocol for a pilot study of feasibility of a randomized controlled trial. Contemp Clin Trials Commun. 2025 Feb 3;44:101439. doi: 10.1016/j.conctc.2025.101439. eCollection 2025 Apr.
Provided Documents
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Document Type: Informed Consent Form
Other Identifiers
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21-00507
Identifier Type: -
Identifier Source: org_study_id
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