NCT Number: NCT07741357
The purpose of study is to investigate whether adding palliative care to usual chronic kidney disease (CKD) care improves symptoms and quality of life for people with CKD. The primary objectives are to 1) determine efficacy of Kidney Palliative Care (KPC) integrated with CKD care on symptom burden compared with usual CKD care, 2) identify clinical and demographic factors associated with differential responses to KPC, and 3) characterize participant and provider experiences with kidney care and factors influencing implementation.
Trial opening soon.
Get Notified18 year and older
All sexes
Interventional
Not applicable
Emory University, Atlanta, Georgia, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Core components include assessment of symptoms (IPOS-Renal), illness understanding, goals of care, advance care planning, spiritual needs, and screening for health-related social needs (HRSNs) using the validated Centers for Medicare and Medicaid Services (CMS) Accountable Health Communities (AHC) Survey. Plans will address symptom management with evidence-based algorithms, linkage to social or spiritual supports, and shared decision-making appropriate to CKD stage.
Time frame: Baseline, Week 12
The IPOS-Renal Patient Version includes 10 questions (scored 0-90), with sub-scores for physical symptoms (15 questions, range 0-60), psychological symptoms (four questions, range 0-16), and practical impact of CKD (four questions, range 0-14). Higher scores indicate a higher burden of symptoms and greater distress for the patient.
Time frame: Baseline, Week 24
The IPOS-Renal Patient Version includes 10 questions (scored 0-90), with sub-scores for physical symptoms (15 questions, range 0-60), psychological symptoms (four questions, range 0-16), and practical impact of CKD (four questions, range 0-14). Higher scores indicate a higher burden of symptoms and greater distress for the patient.
Time frame: Baseline, Week 12
The KDQOL-36 is a 36-item short-form survey designed to measure the health-related quality of life for individuals with kidney disease and those on dialysis. Items 1-12 (SF-12): Measures generic physical and mental health functioning. Items 13-16 (Burden of Kidney Disease): Assesses how much kidney disease interferes with daily life. Items 17-28 (Symptoms and Problems): Evaluates common physical issues and symptoms related to kidney failure. Items 29-36 (Effects of Kidney Disease): Focuses on daily impacts like fluid restrictions, work around the house, and personal life. Transformed to a 0-100 scale, where higher scores represent a better quality of life.
Time frame: Baseline, Week 24
The KDQOL-36 is a 36-item short-form survey designed to measure the health-related quality of life for individuals with kidney disease and those on dialysis. Items 1-12 (SF-12): Measures generic physical and mental health functioning. Items 13-16 (Burden of Kidney Disease): Assesses how much kidney disease interferes with daily life. Items 17-28 (Symptoms and Problems): Evaluates common physical issues and symptoms related to kidney failure. Items 29-36 (Effects of Kidney Disease): Focuses on daily impacts like fluid restrictions, work around the house, and personal life. Transformed to a 0-100 scale, where higher scores represent a better quality of life.
Time frame: Week 12
Outcome measure will be assessed by chart review. Advance care planning includes proxy, Medical Orders for Life-Sustaining Treatment (MOLST)/Physician/Provider Orders for Life-Sustaining Treatment (POLST), and advance care planning conversations.
Time frame: Week 24
Outcome measure will be assessed by chart review. Advance care planning includes proxy, Medical Orders for Life-Sustaining Treatment (MOLST)/Physician/Provider Orders for Life-Sustaining Treatment (POLST), and advance care planning conversations.
Time frame: Baseline, Week 12
The PAM-13 is a 13-item survey that evaluates a person's knowledge, skills, and confidence in managing their own health and healthcare. 13 statements answered on a 4-point Likert scale (strongly disagree to strongly agree). Scores range from 0-100. Score ≤ 47.0: Disengagement and disbelief; the person may not feel an active role is important. Score 47.1-55.1: Increasing awareness and knowledge, but still lacks confidence to take action. Score 55.2-67.0: Taking action and gaining readiness to manage health behaviors. Score ≥ 67.1: Sustainment; the person adopts and maintains healthy behaviors even under stress.
Time frame: Baseline, Week 24
The PAM-13 is a 13-item survey that evaluates a person's knowledge, skills, and confidence in managing their own health and healthcare. 13 statements answered on a 4-point Likert scale (strongly disagree to strongly agree). Scores range from 0-100. Score ≤ 47.0: Disengagement and disbelief; the person may not feel an active role is important. Score 47.1-55.1: Increasing awareness and knowledge, but still lacks confidence to take action. Score 55.2-67.0: Taking action and gaining readiness to manage health behaviors. Score ≥ 67.1: Sustainment; the person adopts and maintains healthy behaviors even under stress.
Time frame: Baseline, Week 12
GAD-7 consists of 7 problems. Participants report how often they have been bothered by the 7 problems over the last 2 weeks on a Likert Scale from 0 (not at all) to 3 (nearly every day). The total score range is 0-21; the higher the score, the more severe the anxiety. 0-4=minimal anxiety, 5-9=mild, 10-14=moderate, 15-21=severe anxiety.
Time frame: Baseline, Week 24
GAD-7 consists of 7 problems. Participants report how often they have been bothered by the 7 problems over the last 2 weeks on a Likert Scale from 0 (not at all) to 3 (nearly every day). The total score range is 0-21; the higher the score, the more severe the anxiety. 0-4=minimal anxiety, 5-9=mild, 10-14=moderate, 15-21=severe anxiety.
Contact information is provided by the study sponsor or research team.
Jennifer Scherer, MD, MS, FASN
CONTACT
Rachel Monahan
CONTACT
NYU Langone Health
Other
Phase II Multi-Site Randomized Controlled Trial Testing Integrated Kidney Palliative Care Compared With Usual Chronic Kidney Disease Care (Kidney RISE)
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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