Group-based Chronic Kidney Disease Care

NCT ID: NCT02467894

Last Updated: 2019-03-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-08-31
• Study Completion Date: 2017-08-31

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.

Conditions

Chronic Kidney Disease; Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Group-based Care

Intervention Type: OTHER

There will be self-care activities, blood pressure measurements and other vitals, including discussion of specific topics initiated by the participants.

Usual Care

Participants who are randomized to usual care will see their provider on clinic days when there is no group meeting.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Group-based Care

There will be self-care activities, blood pressure measurements and other vitals, including discussion of specific topics initiated by the participants.

Intervention Type: OTHER

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

• Minimum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Albert Einstein College of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Michal L. Melamed

Associate Professor Of Medicine & Epidemiology & Population Health

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Albert Einstein College of Medicine

The Bronx, New York, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 32734251 (View on PubMed)

Other Identifiers

2014-3117

Identifier Type: -

Identifier Source: org_study_id