Group-based Chronic Kidney Disease Care

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Group-based Chronic Kidney Disease Care

Conditions
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Chronic Kidney Disease, Hypertension

Intervention / Treatment
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* Other: Group-based Care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group-based Care<br>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. | Other: Group-based Care<br>* There will be self-care activities, blood pressure measurements and other vitals, including discussion of specific topics initiated by the participants.<br>|
| No Intervention: Usual Care<br>Participants who are randomized to usual care will see their provider on clinic days when there is no group meeting. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood pressure control | The primary outcome will be blood pressure control (mean SBP <140 mmHg) as measured by 24-hour ambulatory blood pressure monitor. | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Adherence, Exercise