Kidney Awareness Registry and Education

Not Applicable

Completed

• Conditions: Chronic Kidney Disease (CKD)
• Interventions: Behavioral: Usual care; Behavioral: CKD Registry; Behavioral: ATSM + Health Coach

• Registration Number: NCT01530958
• Lead Sponsor: University of California, San Francisco

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-02-07
• Study First Submitted QC: 2012-02-09
• Study First Posted: 2012-02-10
• Study Start: 2013-04
• Primary Completion: 2019-12-31
• Study Completion: 2020-12-31
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-19
• Last Update Posted: 2021-01-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 375

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Usual Care (no interventions)	Usual care	-
ATSM + Health Coach and CKD Registry	CKD Registry	-
ATSM + Health Coach and CKD Registry	ATSM + Health Coach	-
CKD Registry	CKD Registry	-
ATSM + Health Coach	ATSM + Health Coach	-

Primary Outcome Measures

Name	Time	Method
Change in blood pressure measurement at baseline and at one year follow-up	Baseline and one year follow-up	Blood pressure will be measured at baseline and also at the follow-up visit at one year

Secondary Outcome Measures

Name	Time	Method
Change in CKD awareness, functional status, and symptoms at baseline and at one year follow-up	Baseline and one year follow-up	CKD 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.

Trial Locations

Locations (2)

San Francisco General Hospital; 🇺🇸 San Francisco, California, United States

San Francisco Department of Public Health; 🇺🇸 San Francisco, California, United States