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Purpose

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.

Conditions

Eligibility

Eligible Ages
Over 12 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

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

More Details

Status
Completed
Sponsor
Albert Einstein College of Medicine

Study Contact

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.