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Kidney Awareness Registry and Education

The Kidney Awareness Registry and Education Study

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01530958
Acronym
KARE
Enrollment
375
Registered
2012-02-10
Start date
2013-04-01
Completion date
2020-12-31
Last updated
2026-06-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Kidney Disease (CKD)

Keywords

CKD, Automated Telephone Self Management, Registry, CKD awareness, Self efficacy

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.

Interventions

BEHAVIORALCKD 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

BEHAVIORALATSM + 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.

BEHAVIORALUsual care

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

Sponsors

University of California, San Francisco
Lead SponsorOTHER
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
CollaboratorNIH

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Change in blood pressure measurement at baseline and at one year follow-upBaseline and one year follow-upBlood pressure will be measured at baseline and also at the follow-up visit at one year

Secondary

MeasureTime frameDescription
Change in CKD awareness, functional status, and symptoms at baseline and at one year follow-upBaseline and one year follow-upCKD 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.

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORNeil Powe, MD

University of California, San Francisco

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 10, 2026