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.
Brief Title
Group-based Chronic Kidney Disease Care
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.
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.
Completion Date
Completion Date Type
Actual
Conditions
Chronic Kidney Disease
Hypertension
Eligibility Criteria
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
* 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
Inclusion Criteria
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
* 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
Gender
All
Gender Based
false
Keywords
Adherence
Exercise
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
12 Years
NCT Id
NCT02467894
Org Class
Other
Org Full Name
Albert Einstein College of Medicine
Org Study Id
2014-3117
Overall Status
Completed
Phases
Not Applicable
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
Group-based Chronic Kidney Disease Care
Primary Outcomes
Outcome Description
The primary outcome will be blood pressure control (mean SBP \<140 mmHg) as measured by 24-hour ambulatory blood pressure monitor.
Outcome Measure
Blood pressure control
Outcome Time Frame
6 months
Start Date
Status Verified Date
First Post Date
First Post Date Type
Estimated
First Submit Date
First Submit QC Date
Std Ages
Child
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
12
Investigators
Investigator Type
Principal Investigator
Investigator Name
Michal Melamed
Investigator Email
michal.melamed@einsteinmed.org
Investigator Phone
718-430-2304