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Kidney Awareness Registry and Education (KARE)

Primary Purpose

Chronic Kidney Disease (CKD)

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

CKD Registry

ATSM + Health Coach

Usual care

About this trial

This is an interventional health services research trial for Chronic Kidney Disease (CKD) focused on measuring CKD, Automated Telephone Self Management, Registry, CKD awareness, Self efficacy

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

San Francisco Department of Public Health
San Francisco General Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

ATSM + Health Coach and CKD Registry

CKD Registry

ATSM + Health Coach

Usual Care (no interventions)

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT01530958

First Posted

February 7, 2012

Last Updated

January 19, 2021

Sponsor

University of California, San Francisco

Collaborators

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

1. Study Identification

Unique Protocol Identification Number

NCT01530958

Brief Title

Kidney Awareness Registry and Education

Acronym

KARE

Official Title

The Kidney Awareness Registry and Education Study

Study Type

Interventional

2. Study Status

Record Verification Date

January 2021

Overall Recruitment Status

Completed

Study Start Date

April 2013 (Actual)

Primary Completion Date

December 31, 2019 (Actual)

Study Completion Date

December 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of California, San Francisco

Collaborators

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Kidney Disease (CKD)

Keywords

CKD, Automated Telephone Self Management, Registry, CKD awareness, Self efficacy

7. Study Design

Primary Purpose

Health Services Research

Study Phase

Not Applicable

Interventional Study Model

Factorial Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

375 (Actual)

8. Arms, Groups, and Interventions

Arm Title

ATSM + Health Coach and CKD Registry

Arm Type

Experimental

Arm Title

CKD Registry

Arm Type

Active Comparator

Arm Title

ATSM + Health Coach

Arm Type

Active Comparator

Arm Title

Usual Care (no interventions)

Arm Type

Placebo Comparator

Intervention Type

Behavioral

Intervention Name(s)

CKD Registry

Intervention Description

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

Intervention Name(s)

ATSM + Health Coach

Intervention Description

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

Intervention Name(s)

Usual care

Intervention Description

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

Primary Outcome Measure Information:

Title

Change in blood pressure measurement at baseline and at one year follow-up

Description

Blood pressure will be measured at baseline and also at the follow-up visit at one year

Time Frame

Baseline and one year follow-up

Secondary Outcome Measure Information:

Title

Change in CKD awareness, functional status, and symptoms at baseline and at one year follow-up

Description

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.

Time Frame

Baseline and one year follow-up

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Neil Powe, MD

Organizational Affiliation

University of California, San Francisco

Official's Role

Principal Investigator

Facility Information:

Facility Name

San Francisco Department of Public Health

City

San Francisco

State/Province

California

ZIP/Postal Code

94110

Country

United States

Facility Name

San Francisco General Hospital

City

San Francisco

State/Province

California

ZIP/Postal Code

94110

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Undecided

IPD Sharing Plan Description

Data may be available upon contact of study PI.

Citations:

PubMed Identifier

33973868

Citation

Machen L, Handley MA, Powe N, Tuot D. Engagement With a Health Information Technology-Augmented Self-Management Support Program in a Population With Limited English Proficiency: Observational Study. JMIR Mhealth Uhealth. 2021 May 11;9(5):e24520. doi: 10.2196/24520.

Results Reference

derived

PubMed Identifier

32734204

Citation

Tuot DS, Rubinsky AD, Velasquez A, McCulloch CE, Schillinger D, Handley MA, Hsu CY, Powe NR. Interventions to Improve Blood Pressure Control Among Socioeconomically Disadvantaged Patients With CKD: Kidney Awareness Registry and Education Pilot Randomized Controlled Trial. Kidney Med. 2019 Aug 30;1(5):242-252. doi: 10.1016/j.xkme.2019.07.004. eCollection 2019 Sep-Oct.

Results Reference

derived

PubMed Identifier

26494562

Citation

Tuot DS, Velasquez A, McCulloch CE, Banerjee T, Zhu Y, Hsu CY, Handley M, Schillinger D, Powe NR. The Kidney Awareness Registry and Education (KARE) study: protocol of a randomized controlled trial to enhance provider and patient engagement with chronic kidney disease. BMC Nephrol. 2015 Oct 22;16:166. doi: 10.1186/s12882-015-0168-4.

Results Reference

derived

Learn more about this trial

Kidney Awareness Registry and Education

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