Kidney Awareness Registry and Education

Study Overview
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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.

Official Title
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The Kidney Awareness Registry and Education Study

Conditions
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Chronic Kidney Disease (CKD)

Intervention / Treatment
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* Behavioral: CKD Registry
* Behavioral: ATSM + Health Coach
* Behavioral: Usual care


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ATSM + Health Coach and CKD Registry<br> | Behavioral: CKD Registry<br>* 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<br>Behavioral: ATSM + Health Coach<br>* 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.<br>|
| Active Comparator: CKD Registry<br> | Behavioral: CKD Registry<br>* 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<br>|
| Active Comparator: ATSM + Health Coach<br> | Behavioral: ATSM + Health Coach<br>* 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.<br>|
| Placebo Comparator: Usual Care (no interventions)<br> | Behavioral: Usual care<br>* Primary care providers will manage their patients with CKD per usual care. Patients will receive usual care.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in blood pressure measurement at baseline and at one year follow-up | Blood pressure will be measured at baseline and also at the follow-up visit at one year | Baseline and one year follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in CKD awareness, functional status, and symptoms at baseline and at 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. | Baseline and one year follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CKD, Automated Telephone Self Management, Registry, CKD awareness, Self efficacy