Kidney Awareness Registry and Education

Chronic Kidney Disease (CKD) Clinical Trial

— KARE  

Official title:

The Kidney Awareness Registry and Education Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01530958
• Other study ID #: 11-07399
• Secondary ID: 1R34DK093992-01
• Status: Completed
• Phase: N/A
• Start date: April 2013
• Est. completion date: December 31, 2020

Study information

• Verified date: January 2021
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the feasibility and acceptability of two different interventions aimed at improving health outcomes among patients with chronic kidney disease (CKD), who are at high risk of CKD progression. Specifically, this study will examine how best to implement a provider-level intervention (access to a CKD-registry) and a patient-oriented intervention (automated telephone self-management (ATSM) + health coach) on patient health outcomes, with a 2x2 factorial design.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 375
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Patients with CKD (defined as estimated Glomerular Filtration Rate < 60ml/min/1.73m2 or proteinuria consistently over 3 months) who speak English, Spanish or Cantonese and have a primary care provider

Exclusion Criteria:

• Kidney transplant recipients; pregnant women; individuals with an eGFR <15 ml/min/1.73 m2; prevalent dementia; impaired cognition or severe mental illness; expected life expectancy <6 months; no phone access; self-reported hearing impairment; severe visual impairment preventing use of a touch-tone telephone keypad; and non-study language

Related Conditions & MeSH terms

• Chronic Kidney Disease (CKD)
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Behavioral:
• CKD Registry
Primary care providers (PCPs) will have access to a Chronic Kidney Disease (CKD) registry for patient care. The registry will: identify patients with CKD notify PCPs of a patients' CKD status provide PCP outreach with NKDEP guidelines and patient educational materials
• ATSM + Health Coach
Patients with CKD will participate in an Automated Telephone Self Management (ATSM) program, which blends automated phone calls with live targeted call-backs from a health coach. Patients will receive bi-weekly automated calls for 52 weeks in their native language, consisting of pre-recorded queries pertaining to CKD management, preventive services, and lifestyle changes. Patients will interact with the system using a touch-tone keypad; Out-of-range values or invalid responses will prompt a live call-back within 24-48 hours by a health coach.
• Usual care
Primary care providers will manage their patients with CKD per usual care. Patients will receive usual care.

Locations

Country	Name	City	State
United States	San Francisco Department of Public Health	San Francisco	California
United States	San Francisco General Hospital	San Francisco	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Francisco	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in blood pressure measurement at baseline and at one year follow-up	Blood pressure will be measured at baseline and also at the follow-up visit at one year	Baseline and one year follow-up
Secondary	Change in CKD awareness, functional status, and symptoms at baseline and at one year follow-up	CKD awareness, functional status, and symptoms will be measured at baseline and also at the follow-up visit at one year. Assessments will be made by standardized phone calls throughout the study.	Baseline and one year follow-up