Kidney Awareness Registry and Education

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

375 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-04-30

Study Completion Date

2020-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Chronic Kidney Disease (CKD)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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ATSM + Health Coach and CKD Registry

Group Type EXPERIMENTAL

CKD Registry

Intervention Type BEHAVIORAL

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

ATSM + Health Coach

Intervention Type BEHAVIORAL

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.

CKD Registry

Group Type ACTIVE_COMPARATOR

CKD Registry

Intervention Type BEHAVIORAL

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

ATSM + Health Coach

Group Type ACTIVE_COMPARATOR

ATSM + Health Coach

Intervention Type BEHAVIORAL

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.

Usual Care (no interventions)

Group Type PLACEBO_COMPARATOR

Usual care

Intervention Type BEHAVIORAL

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

Patients will receive usual care.

Interventions

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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

Intervention Type 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.

Intervention Type BEHAVIORAL

Usual care

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

Patients will receive usual care.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes