Kidney Awareness Registry and Education
KARE
The Kidney Awareness Registry and Education Study
2 other identifiers
interventional
375
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2013
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 7, 2012
CompletedFirst Posted
Study publicly available on registry
February 10, 2012
CompletedStudy Start
First participant enrolled
April 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2020
CompletedJanuary 22, 2021
January 1, 2021
6.8 years
February 7, 2012
January 19, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in blood pressure measurement at baseline and at one year follow-up
Blood pressure will be measured at baseline and also at the follow-up visit at one year
Baseline and one year follow-up
Secondary Outcomes (1)
Change in CKD awareness, functional status, and symptoms at baseline and at one year follow-up
Baseline and one year follow-up
Study Arms (4)
ATSM + Health Coach and CKD Registry
EXPERIMENTALCKD Registry
ACTIVE COMPARATORATSM + Health Coach
ACTIVE COMPARATORUsual Care (no interventions)
PLACEBO COMPARATORInterventions
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
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.
Primary care providers will manage their patients with CKD per usual care. Patients will receive usual care.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
San Francisco Department of Public Health
San Francisco, California, 94110, United States
San Francisco General Hospital
San Francisco, California, 94110, United States
Related Publications (4)
Campbell ZC, Dawson JK, Kirkendall SM, McCaffery KJ, Jansen J, Campbell KL, Lee VW, Webster AC. Interventions for improving health literacy in people with chronic kidney disease. Cochrane Database Syst Rev. 2022 Dec 6;12(12):CD012026. doi: 10.1002/14651858.CD012026.pub2.
PMID: 36472416DERIVEDMachen L, Handley MA, Powe N, Tuot D. Engagement With a Health Information Technology-Augmented Self-Management Support Program in a Population With Limited English Proficiency: Observational Study. JMIR Mhealth Uhealth. 2021 May 11;9(5):e24520. doi: 10.2196/24520.
PMID: 33973868DERIVEDTuot DS, Rubinsky AD, Velasquez A, McCulloch CE, Schillinger D, Handley MA, Hsu CY, Powe NR. Interventions to Improve Blood Pressure Control Among Socioeconomically Disadvantaged Patients With CKD: Kidney Awareness Registry and Education Pilot Randomized Controlled Trial. Kidney Med. 2019 Aug 30;1(5):242-252. doi: 10.1016/j.xkme.2019.07.004. eCollection 2019 Sep-Oct.
PMID: 32734204DERIVEDTuot 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.
PMID: 26494562DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Neil Powe, MD
University of California, San Francisco
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 7, 2012
First Posted
February 10, 2012
Study Start
April 1, 2013
Primary Completion
December 31, 2019
Study Completion
December 31, 2020
Last Updated
January 22, 2021
Record last verified: 2021-01