Group-based Chronic Kidney Disease Care

Not Applicable

Completed

• Conditions: Chronic Kidney Disease; Hypertension
• Interventions: Other: Group-based Care

• Registration Number: NCT02467894
• Lead Sponsor: Albert Einstein College of Medicine

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2014-08
• Study First Submitted: 2015-06-08
• Study First Submitted QC: 2015-06-08
• Study First Posted: 2015-06-10
• Primary Completion: 2017-08
• Study Completion: 2017-08
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-11
• Last Update Posted: 2019-03-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group-based Care	Group-based Care	Participants who are randomized to group-based care will attend monthly outpatient clinic visits as part of a group of 8-10 patients with CKD and hypertension.

Primary Outcome Measures

Name	Time	Method
Blood pressure control	6 months	The primary outcome will be blood pressure control (mean SBP \<140 mmHg) as measured by 24-hour ambulatory blood pressure monitor.

Trial Locations

Locations (1)

Albert Einstein College of Medicine; 🇺🇸 Bronx, New York, United States