Group-based Chronic Kidney Disease Care



Status:Completed
Conditions:High Blood Pressure (Hypertension), Renal Impairment / Chronic Kidney Disease
Therapuetic Areas:Cardiology / Vascular Diseases, Nephrology / Urology
Healthy:No
Age Range:12 - Any
Updated:3/15/2019
Start Date:August 2014
End Date:August 2017

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A two-group randomized clinical trial testing whether group-based care is feasible and will
help improve blood pressure control in adult and adolescent patients with chronic kidney
disease and hypertension.

This two-group RCT will enroll 100 subjects, adolescents over or equal to 12 years of age,
and men and women over age of 21, with stage 3-4 and 5 CKD from various causes including
diabetes and hypertension. Patients will be recruited from the Montefiore Medical Center
Nephrology. The primary aim will be to assess feasibility of the intervention.

Informed consent will be obtained on all subjects. All subjects with meet with one of the
investigators who will verbally explain to them the purpose of the study and the
alternatives.

Blood and 24 hr urine test will be collected to assess for sodium, phosphorus, and serum
creatinine. These tests will be used for experimental purposes only and will be collected at
enrollment and 6 months visit.

There will be two arms, an arm randomized to Group-based care attending monthly outpatient
clinic visits as part of a group and the other to usual care who will see their provider once
a month for 6 months.

Inclusion Criteria:

- Adolescent Age ≥12 years old

- Sufficient hearing, vision, and proficiency in English or Spanish to comprehend low-
literacy printed educational materials and participate in group sessions (assessed by
provider)

- Adult: (¬>21 years): Systolic blood pressure >140 at two clinic visits in the past
year or >160 at one visit and Adolescent: (12-21 years) systolic blood pressure >95
percentile (based on sex and age) at 2 clinic visits in the past year

- For adults: Stage 3-5 CKD (eGFR<60 ml/min/1.73m2)

- For adolescents: evidence of kidney damage (albuminuria, congenital anomalies of the
kidney or urinary tract) and hypertension

- Prescription for anti-hypertensive medication (in adults)

- Unwillingness to accept random assignment

- Unwillingness to provide informed consent

Exclusion Criteria:

- Transplanted organ

- Rapidly deteriorating kidney function with the expectation for initiation of dialysis
in less than 6 months

- Plans to relocate out of New York City in the next 6 months
We found this trial at
1
site
1300 Morris Park Ave
Bronx, New York 10461
(718) 430-2000
Albert Einstein College of Medicine The Albert Einstein College of Medicine of Yeshiva University is...
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mi
from
Bronx, NY
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