Kidney Awareness Registry and Education (KARE)

University of California San Francisco (UCSF)

Status: Completed

Conditions: Chronic Kidney Disease (CKD)

Treatments: Behavioral: CKD Registry; Behavioral: Usual care; Behavioral: ATSM + Health Coach

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01530958

1R34DK093992-01 (U.S. NIH Grant/Contract)

11-07399

Details and patient eligibility

About

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.

Enrollment: 375 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Single Blind

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375 participants in 4 patient groups, including a placebo group

ATSM + Health Coach and CKD Registry

Experimental group

Treatment:

Behavioral: CKD Registry

Behavioral: ATSM + Health Coach

CKD Registry

Active Comparator group

Treatment:

Behavioral: CKD Registry

ATSM + Health Coach

Active Comparator group

Treatment:

Behavioral: ATSM + Health Coach

Usual Care (no interventions)

Placebo Comparator group

Treatment:

Behavioral: Usual care