Clinical trial NCT02467894: Group-based Chronic Kidney Disease Care
Official title: Group-based Chronic Kidney Disease Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Kidney Disease
Hypertension
Keywords: Adherence
Exercise
Lead sponsor: Albert Einstein College of Medicine
Sponsor class: OTHER
First posted: 2015-06-10
Enrollment: 60
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Blood pressure control
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
measure: Accelerometer
timeFrame: 6 months
measure: Medication Adherence
timeFrame: 6 months
measure: Quality of Life
timeFrame: 6 months
measure: Health Resources and Services Administration (HRSA)
timeFrame: 6 months
Locations:
city: Bronx
country: United States
facility: Albert Einstein College of Medicine
state: New York
Study officials:
References:
citation: Johns TS, Brown DD, Litwin AH, Goldson G, Buttar RS, Kreimerman J, Lo Y, Reidy KJ, Bauman L, Kaskel F, Melamed ML. Group-Based Care in Adults and Adolescents With Hypertension and CKD: A Feasibility Study. Kidney Med. 2020 Apr 18;2(3):317-325. doi: 10.1016/j.xkme.2020.01.013. eCollection 2020 May-Jun.