Integrated Nephrology and Palliative Care Impact on Symptom Burden, Quality of Life and Advance Care Planning in Chronic Kidney Disease Stage V Patients
This early phase study aims to evaluate the impact of integrated nephrology and palliative care on symptom burden, quality of life, and advance care planning in patients with stage V chronic kidney disease.
Integrated ambulatory palliative and nephrology care
+ Standard nephrology care
Urogenital Diseases+9
+ Chronic Disease
+ Female Urogenital Diseases and Pregnancy Complications
Treatment Study
Summary
Study start date: July 12, 2020
Actual date on which the first participant was enrolled.This study aims to test the impact of combining palliative care with standard nephrology care, compared to standard nephrology care alone, on patient-reported outcomes. The focus is on patients with Chronic Kidney Disease Stage V who are not on dialysis and have a glomerular filtration rate (eGFR) of 15ml/min/1.73m2 or less. The study hypothesizes that this integration could improve symptom control, quality of life, and increase the documentation of advance care planning. It's a preliminary study designed to determine the feasibility of a palliative care study inclusive of kidney disease patients. Over a 12-week period, measurements will be taken at the time of enrollment and at the end of the study. The study will evaluate changes in symptom burden using a short measure called IPOS-Renal, which includes 11 questions about common symptoms and concerns for renal patients. It will also assess changes in quality of life using the KDQOL-36, a scale with five sections including two general health-related quality of life scales and three kidney-specific scales. Lastly, the study will compare the number of documented advanced care planning, such as health care proxy or Do Not Resituate forms, between the two groups.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.45 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Inclusion Criteria: In order to be eligible to participate in this study, an individual must meet all of the following criteria: 1. Age ≥18 2. Fluent English speaker 3. eGFR≤15 mL/min/1.73m2 (diagnosis of CKD stage V) 4. Able to give consent 5. Must be followed by a faculty group practice nephrologist Exclusion Criteria: An individual who meets any of the following criteria will be excluded from participation in this study: 1. Diagnosis of dementia 2. Non-English speaker 3. Have been seen by a palliative care provider prior to study entry 4. Pregnant women 5. On dialysis or have received a kidney transplant
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalGroup II
Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location