NCT02059408

Brief Summary

The overall hypothesis of this trial is that screening for chronic kidney disease, followed by education or treatment program will improve blood pressure control among hypertensive non-diabetic persons.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,819

participants targeted

Target at P75+ for not_applicable hypertension

Timeline
Completed

Started Sep 2015

Typical duration for not_applicable hypertension

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 17, 2014

Completed
25 days until next milestone

First Posted

Study publicly available on registry

February 11, 2014

Completed
1.6 years until next milestone

Study Start

First participant enrolled

September 1, 2015

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
1 year until next milestone

Results Posted

Study results publicly available

December 4, 2019

Completed
Last Updated

January 7, 2020

Status Verified

December 1, 2019

Enrollment Period

1.3 years

First QC Date

January 17, 2014

Results QC Date

November 12, 2019

Last Update Submit

December 18, 2019

Conditions

Hypertension

Outcome Measures

Primary Outcomes (1)

  • Change in Blood Pressure

    Change in blood pressure from enrollment to the end of the 12-month follow up period as a continuous outcome,

    baseline, 12 months

Secondary Outcomes (1)

  • ACE/ARB Prescription by a Clinician

    12 months

Other Outcomes (2)

  • Testing Time

    24 months

  • Testing Cost

    24 months

Study Arms (3)

Usual Care

NO INTERVENTION

The patients in this arm will receive normal primary care.

Screen-Educate

ACTIVE COMPARATOR

Education program to improve blood pressure control among hypertensive non-diabetic persons. The Screen and Educate arm recommends using creatinine, cystatin C and albuminuria for detection and risk stratification, followed by guideline-concordant CKD management appropriate for CKD stage.

Other: Screen-Educate

Screen-Educate and Intensify Treatment

ACTIVE COMPARATOR

Education and treatment program to improve blood pressure control among hypertensive non-diabetic persons. The Screen-Educate and Intensify Treatment adds a pharmacist-led CKD management program and attempts to improve BP management and patient-centered outcomes among persons with newly stratified higher risk CKD based on creatinine, cystatin c and albuminuria.

Other: Screen-EducateOther: Screen-Educate and Intensify Treatment

Interventions

Screen-EducateOTHER

Education program to improve blood pressure control among hypertensive non-diabetic persons. The Screen and Educate arm will recommend using creatinine, cystatin C and albuminuria for screening and risk stratification, followed by guideline-concordant CKD management appropriate for CKD stage. Recommendations are sent to the primary care provider via an electronic note.

Screen-EducateScreen-Educate and Intensify Treatment
Screen-Educate and Intensify TreatmentOTHER

This arm adds option of a pharmacist. PCPs randomized to this arm will have the additional option to refer their higher-risk patients to a clinical pharmacist-led CKD management program with education. A primary care clinical pharmacist will schedule a series of appointments with patients found to have confirmed higher-risk CKD (defined as eGFRcreat-cys \<45, or eGFR 45-59 and ACR ≥ 30 mg/g). The pharmacist will follow treatment algorithms recommended by the 2012 KDIGO international CKD guidelines, and designed by a team of internists and nephrologists.

Screen-Educate and Intensify Treatment

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

San Francisco Veteran Affairs Medical Center

San Francisco, California, 94121, United States

Location

Related Publications (5)

  • Coresh J, Byrd-Holt D, Astor BC, Briggs JP, Eggers PW, Lacher DA, Hostetter TH. Chronic kidney disease awareness, prevalence, and trends among U.S. adults, 1999 to 2000. J Am Soc Nephrol. 2005 Jan;16(1):180-8. doi: 10.1681/ASN.2004070539. Epub 2004 Nov 24.

    PMID: 15563563BACKGROUND

  • Peralta CA, Shlipak MG, Judd S, Cushman M, McClellan W, Zakai NA, Safford MM, Zhang X, Muntner P, Warnock D. Detection of chronic kidney disease with creatinine, cystatin C, and urine albumin-to-creatinine ratio and association with progression to end-stage renal disease and mortality. JAMA. 2011 Apr 20;305(15):1545-52. doi: 10.1001/jama.2011.468. Epub 2011 Apr 11.

    PMID: 21482744BACKGROUND

  • Shlipak MG, Coresh J, Gansevoort RT. Cystatin C versus creatinine for kidney function-based risk. N Engl J Med. 2013 Dec 19;369(25):2459. doi: 10.1056/NEJMc1312801. No abstract available.

    PMID: 24350959BACKGROUND

  • Stevens PE, Levin A; Kidney Disease: Improving Global Outcomes Chronic Kidney Disease Guideline Development Work Group Members. Evaluation and management of chronic kidney disease: synopsis of the kidney disease: improving global outcomes 2012 clinical practice guideline. Ann Intern Med. 2013 Jun 4;158(11):825-30. doi: 10.7326/0003-4819-158-11-201306040-00007.

    PMID: 23732715BACKGROUND

  • Peralta CA, Frigaard M, Rubinsky AD, Rolon L, Lo L, Voora S, Seal K, Tuot D, Chao S, Lui K, Chiao P, Powe N, Shlipak M. Implementation of a pragmatic randomized trial of screening for chronic kidney disease to improve care among non-diabetic hypertensive veterans. BMC Nephrol. 2017 Apr 12;18(1):132. doi: 10.1186/s12882-017-0541-6.

    PMID: 28399844DERIVED

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Limitations and Caveats

A limitation in this study was that over 50% of eligible patients were not tested.

Results Point of Contact

Title
Carmen Peralta, Professor of Medicine
Organization
University of California, San Francisco
carmenalicia.peralta@ucsf.edu
415-221-4810

Study Officials

  • Carmen A Peralta, MD, MAS

    San Francisco Veterans Affairs Medical Center

    PRINCIPAL INVESTIGATOR

  • Erica Day, MPH

    San Francisco Veterans Affairs Medical Center

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 17, 2014

First Posted

February 11, 2014

Study Start

September 1, 2015

Primary Completion

January 1, 2017

Study Completion

December 1, 2018

Last Updated

January 7, 2020

Results First Posted

December 4, 2019

Record last verified: 2019-12

Data Sharing

IPD Sharing
Will not share

There is not currently a plan to make the IDP data available.

Locations

US(1)