Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

Kidney Awareness Registry and Education (KARE)

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2016 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 26, 2016
Last verified: October 2016

February 7, 2012
October 26, 2016
April 2013
December 2017   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01530958 on ClinicalTrials.gov Archive Site
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.
Same as current
Not Provided
Not Provided
 
Kidney Awareness Registry and Education
The Kidney Awareness Registry and Education Study
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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Health Services Research
Chronic Kidney Disease (CKD)
  • 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.
  • Behavioral: Usual care

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

    Patients will receive usual care.

  • Experimental: ATSM + Health Coach and CKD Registry
    Interventions:
    • Behavioral: CKD Registry
    • Behavioral: ATSM + Health Coach
  • Active Comparator: CKD Registry
    Intervention: Behavioral: CKD Registry
  • Active Comparator: ATSM + Health Coach
    Intervention: Behavioral: ATSM + Health Coach
  • Placebo Comparator: Usual Care (normal standard of care with no interventions)
    Intervention: Behavioral: Usual care
Tuot DS, Velasquez A, McCulloch CE, Banerjee T, Zhu Y, Hsu CY, Handley M, Schillinger D, Powe NR. The Kidney Awareness Registry and Education (KARE) study: protocol of a randomized controlled trial to enhance provider and patient engagement with chronic kidney disease. BMC Nephrol. 2015 Oct 22;16:166. doi: 10.1186/s12882-015-0168-4.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
100
December 2017
December 2017   (final data collection date for primary outcome measure)

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
Both
18 Years to 75 Years   (Adult, Senior)
Yes
Contact: Delphine Tuot, MD 415-206-3784 delphine.tuot@ucsf.edu
Contact: Alexandra Velasquez 415-206-4923 velasqueza@medsfgh.ucsf.edu
United States
 
NCT01530958
11-07399, 1R34DK093992-01
Yes
Undecided
Data may be available upon contact of study PI.
University of California, San Francisco
University of California, San Francisco
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Principal Investigator: Neil Powe, MD University of California, San Francisco
University of California, San Francisco
October 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP