Group-based Chronic Kidney Disease Care

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.

Study Overview

• Status: Completed
• Conditions: Hypertension; Chronic Kidney Disease
• Intervention / Treatment: Other: Group-based 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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • Bronx, New York, United States, 10461
      • Albert Einstein College of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood pressure control	The primary outcome will be blood pressure control (mean SBP <140 mmHg) as measured by 24-hour ambulatory blood pressure monitor.	6 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Accelerometer	Evaluate effects of group-based care on physical activity	6 months
Medication Adherence	Measured by the Morisky 8-item Medication Adherence scale.	6 months
Quality of Life	We will collect quality of life measurements using the Peds QL in the adolescent group and the SF-36 in the adult sample. We want to evaluate whether group-based care may lead to improved or worse reported quality of life in participants.	6 months
Health Resources and Services Administration (HRSA)	Evaluate patient and provider satisfaction	6 months

Collaborators and Investigators

• Sponsor: Albert Einstein College of Medicine

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: August 1, 2014
• Primary Completion (Actual): August 1, 2017
• Study Completion (Actual): August 1, 2017

Study Registration Dates

• First Submitted: June 8, 2015
• First Submitted That Met QC Criteria: June 8, 2015
• First Posted (Estimate): June 10, 2015

Study Record Updates

• Last Update Posted (Actual): March 13, 2019
• Last Update Submitted That Met QC Criteria: March 11, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Keywords: Adherence; Exercise
• Additional Relevant MeSH Terms: Urologic Diseases; Renal Insufficiency; Kidney Diseases; Renal Insufficiency, Chronic
• Other Study ID Numbers: 2014-3117