Group-based Chronic Kidney Disease Care

A

Albert Einstein College of Medicine

Status

Completed

Conditions

Chronic Kidney Disease
Hypertension

Treatments

Other: Group-based Care

Study type

Interventional

Funder types

Other

Identifiers

NCT02467894
2014-3117

Details and patient eligibility

About

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.

Full 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.

Enrollment

60 patients

Sex

All

Ages

12+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

60 participants in 2 patient groups

Group-based Care
Experimental group
Description:
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.
Treatment:
Other: Group-based Care
Usual Care
No Intervention group
Description:
Participants who are randomized to usual care will see their provider on clinic days when there is no group meeting.

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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