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Kidney Awareness Registry and Education (KARE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01530958
Recruitment Status : Recruiting
First Posted : February 10, 2012
Last Update Posted : December 18, 2019
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
University of California, San Francisco

Tracking Information
First Submitted Date  ICMJE February 7, 2012
First Posted Date  ICMJE February 10, 2012
Last Update Posted Date December 18, 2019
Actual Study Start Date  ICMJE April 2013
Estimated Primary Completion Date December 31, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 9, 2012)
Change in blood pressure measurement at baseline and at one year follow-up [ Time Frame: Baseline and one year follow-up ]
Blood pressure will be measured at baseline and also at the follow-up visit at one year
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 9, 2012)
Change in CKD awareness, functional status, and symptoms at baseline and at one year follow-up [ Time Frame: 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Kidney Awareness Registry and Education
Official Title  ICMJE The Kidney Awareness Registry and Education Study
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Health Services Research
Condition  ICMJE Chronic Kidney Disease (CKD)
Intervention  ICMJE
  • 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.

Study Arms  ICMJE
  • 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 (no interventions)
    Intervention: Behavioral: Usual care
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 15, 2014)
100
Original Estimated Enrollment  ICMJE
 (submitted: February 9, 2012)
800
Estimated Study Completion Date  ICMJE December 31, 2020
Estimated Primary Completion Date December 31, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Delphine Tuot, MD 415-206-3784 delphine.tuot@ucsf.edu
Contact: Alexandra Velasquez 415-206-4923 velasqueza@medsfgh.ucsf.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01530958
Other Study ID Numbers  ICMJE 11-07399
1R34DK093992-01 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Plan Description: Data may be available upon contact of study PI.
Responsible Party University of California, San Francisco
Study Sponsor  ICMJE University of California, San Francisco
Collaborators  ICMJE National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators  ICMJE
Principal Investigator: Neil Powe, MD University of California, San Francisco
PRS Account University of California, San Francisco
Verification Date December 2019

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