Group-based Chronic Kidney Disease Care

Hypertension Clinical Trial

Official title:

Group-based Chronic Kidney Disease Care

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02467894
• Other study ID #: 2014-3117
• Status: Completed
• Phase: N/A
• Start date: August 2014
• Est. completion date: August 2017

Study information

• Verified date: March 2019
• Source: Albert Einstein College of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: August 2017
• Est. primary completion date: August 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Kidney Disease
• Hypertension
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

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.

Locations

Country	Name	City	State
United States	Albert Einstein College of Medicine	Bronx	New York

Sponsors (1)

Lead Sponsor	Collaborator
Albert Einstein College of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Accelerometer	Evaluate effects of group-based care on physical activity	6 months
Other	Medication Adherence	Measured by the Morisky 8-item Medication Adherence scale.	6 months
Other	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
Other	Health Resources and Services Administration (HRSA)	Evaluate patient and provider satisfaction	6 months
Primary	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