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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

Study Description
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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 Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 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 : April 2013
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases

Arms and Interventions
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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
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01530958


Contacts
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Contact: Delphine Tuot, MD 415-206-3784 delphine.tuot@ucsf.edu
Contact: Alexandra Velasquez 415-206-4923 velasqueza@medsfgh.ucsf.edu

Locations
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United States, California
San Francisco Department of Public Health Recruiting
San Francisco, California, United States, 94110
San Francisco General Hospital 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
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Principal Investigator: Neil Powe, MD University of California, San Francisco
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01530958    
Other Study ID Numbers: 11-07399
1R34DK093992-01 ( U.S. NIH Grant/Contract )
First Posted: February 10, 2012    Key Record Dates
Last Update Posted: December 18, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Data may be available upon contact of study PI.
Keywords provided by University of California, San Francisco:
CKD
Automated Telephone Self Management
Registry
CKD awareness
Self efficacy
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency