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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
60
There will be self-care activities, blood pressure measurements and other vitals, including discussion of specific topics initiated by the participants.
Albert Einstein College of Medicine
The Bronx, New York, United States
Blood pressure control
The primary outcome will be blood pressure control (mean SBP \<140 mmHg) as measured by 24-hour ambulatory blood pressure monitor.
Time frame: 6 months
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