KARE: Kidney Awareness Registry and Education

Sponsor

University of California, San Francisco (Other)

Overall Status

Completed

CT.gov ID

NCT01530958

Collaborator

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) (NIH)

375

Enrollment

Locations

Arms

Actual Duration (Months)

187.5

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Kidney Disease (CKD)	Behavioral: CKD Registry Behavioral: ATSM + Health Coach Behavioral: Usual care	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

375 participants

Allocation:

Randomized

Intervention Model:

Factorial Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Health Services Research

Official Title:

The Kidney Awareness Registry and Education Study

Actual Study Start Date :

Apr 1, 2013

Actual Primary Completion Date :

Dec 31, 2019

Actual Study Completion Date :

Dec 31, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: ATSM + Health Coach and CKD Registry	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 Behavioral: 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.
Active Comparator: CKD Registry	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
Active Comparator: ATSM + Health Coach	Behavioral: 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.
Placebo Comparator: Usual Care (no interventions)	Behavioral: Usual care Primary care providers will manage their patients with CKD per usual care. Patients will receive usual care.

Outcome Measures

Primary Outcome Measures

Change in blood pressure measurement at baseline and at one year follow-up [Baseline and one year follow-up]
Blood pressure will be measured at baseline and also at the follow-up visit at one year

Secondary Outcome Measures

Change in CKD awareness, functional status, and symptoms at baseline and at one year follow-up [Baseline and 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	San Francisco Department of Public Health	San Francisco	California	United States	94110
2	San Francisco General Hospital	San Francisco	California	United States	94110