Overview

This trial is active, not recruiting.

Condition chronic kidney disease (ckd)
Treatments ckd registry, atsm + health coach, usual care
Phase phase 3
Sponsor University of California, San Francisco
Collaborator National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Start date April 2013
End date April 2015
Trial size 100 participants
Trial identifier NCT01530958, 11-07399, 1R34DK093992-01

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model factorial assignment
Masking single blind (outcomes assessor)
Primary purpose health services research
Arm
(Experimental)
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
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.
(Active Comparator)
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
(Active Comparator)
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.
(Placebo Comparator)
usual care
Primary care providers will manage their patients with CKD per usual care. Patients will receive usual care.

Primary Outcomes

Measure
Change in blood pressure measurement at baseline and at one year follow-up
time frame: Baseline and one year follow-up

Secondary Outcomes

Measure
Change in CKD awareness, functional status, and symptoms at baseline and at one year follow-up
time frame: Baseline and one year follow-up

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title The Kidney Awareness Registry and Education Study
Principal investigator Neil Powe, MD
Trial information was received from ClinicalTrials.gov and was last updated in August 2014.
Information provided to ClinicalTrials.gov by University of California, San Francisco.