Text Size

Kidney Awareness Registry and Education (KARE)

This study is not yet open for participant recruitment.
Verified October 2012 by University of California, San Francisco
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT01530958
First received: February 7, 2012
Last updated: October 18, 2012
Last verified: October 2012
History of Changes
  Purpose

The purpose of this study is to evaluate the effectiveness and sustainability 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 RCT will examine the impact of 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 Intervention Phase
Chronic Kidney Disease (CKD)
 Behavioral: CKD Registry
Behavioral: ATSM + Health Coach
Behavioral: Usual care
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: The Kidney Awareness Registry and Education Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • Change in blood pressure measurement at baseline and at one year follow-up [ Time Frame: Baseline and one year follow-up ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and one year follow-up ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 800
Study Start Date: January 2013
Estimated Study Completion Date: October 2015
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 (normal standard of care with no interventions) Behavioral: Usual care

Primary care providers will manage their patients with CKD per usual care.

Patients will receive usual care.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Patients with CKD (defined as eGFR < 60ml/min/1.73m2) 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01530958

Contacts
Contact: Delphine Tuot, MD 415-206-3784 delphine.tuot@ucsf.edu

Locations
United States, California
San Francisco General Hospital Not yet recruiting
San Francisco, California, United States, 94110
San Francisco Department of Public Health Not yet recruiting
San Francisco, California, United States, 94110
Sponsors and Collaborators
University of California, San Francisco
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
Principal Investigator: Neil Powe, MD University of California, San Francisco
  More Information

No publications provided

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01530958     History of Changes
Other Study ID Numbers: 11-07399, 1R34DK093992-01
Study First Received: February 7, 2012
Last Updated: October 18, 2012
Health Authority: United States: Federal Government

Keywords provided by University of California, San Francisco:
CKD
Automated Telephone Self Management
Registry
CKD awareness
Self efficacy

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Kidney Failure, Chronic
Urologic Diseases
Renal Insufficiency

ClinicalTrials.gov processed this record on May 16, 2013