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Kidney Awareness Registry and Education

NCT01530958 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 375

Last updated 2021-01-22

No results posted yet for this study

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.

Conditions

  • Chronic Kidney Disease (CKD)

Interventions

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.

Sponsors & Collaborators

Principal Investigators

  • Neil Powe, MD · University of California, San Francisco

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-04-30
Primary Completion
2019-12-31
Completion
2020-12-31

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01530958 on ClinicalTrials.gov