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Screen-and-treat Program for Chronic Kidney Disease- High Risk Persons

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified September 2014 by University of California, San Francisco
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT02059408
First received: January 17, 2014
Last updated: September 4, 2014
Last verified: September 2014
  Purpose

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.


Condition Intervention Phase
Hypertension
Other: Screen-Educate
Other: Screen-Educate and Treat
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Can a Targeted Screen-and-treat Program for Chronic Kidney Disease Improve Blood Pressure (BP) Management Among Persons at High Risk for Complications ?

Resource links provided by NLM:


Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • Change in blood pressure [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Change in blood pressure from enrollment to the end of the 12-month follow up period as a continuous outcome,


Secondary Outcome Measures:
  • ACE/ARB prescription by a clinician [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Percent of persons with controlled blood pressure, defined as less than 140/90 at 2 consecutive visits.


Other Outcome Measures:
  • testing time [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    Time in minutes to order and interpret tests. Reported by Primary Care Providers and pharmacists.

  • Testing Cost [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    Reported by Primary Care Providers and pharmacists. Cost in dollars of testing and pharmacist time.


Estimated Enrollment: 135
Study Start Date: December 2014
Estimated Study Completion Date: May 2017
Estimated Primary Completion Date: January 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Usual Care
Active Comparator: Screen-Educate
education program to improve blood pressure control among hypertensive non-diabetic persons.
Other: Screen-Educate
Active Comparator: Screen-Educate and Intensify Treatment
education and treatment program to improve blood pressure control among hypertensive non-diabetic persons.
Other: Screen-Educate Other: Screen-Educate and Treat

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

The entire primary care medical practice at SFVAMC will be considered. Randomization will occur at the team (nurse) level. Within each team, individual patients will be considered eligible for chronic kidney disease screening by this protocol and inclusion in our trial if they have hypertension without concomitant diabetes, and no prior recorded diagnosis of chronic kidney disease. Hypertension will be defined as systolic blood pressure >140 or diastolic blood pressure >90 mmHg at more than two encounters (any encounter) within the previous 3 years or a documented diagnosis of hypertension (listed in problem list or ICD-9 code). Diagnosed chronic kidney disease will be defined as a documentation of chronic kidney disease in the problem list or ICD-9 code or on-going nephrology follow up. We define diagnosed chronic kidney disease without consideration of estimated glomerular filtration rate by creatinine or albumin-creatinine-ratio in the laboratory section of the medical record, since work from our group and others has shown that awareness and recognition of chronic kidney disease is extremely low, even among persons with documented reduced estimated glomerular filtration rate or albuminuria. Persons will be required to have seen their physician at least one time within the past 18 months.

Exclusion Criteria:

Kidney transplant recipients, pregnant women, and individuals with an estimated glomerular filtration rate <15 ml/min/1.73 m2 will be excluded from this study as they likely need specialty care for uncontrolled hypertension. Persons aged >80 will be excluded because data on aggressive blood pressure lowering in this population are less clear and adverse effects associated with aggressive blood pressure control have been well documented. We will exclude persons with New York Heart Association class III or IV heart failure, known ejection fraction <25%, or documented allergy to Angiotensin-Converting Enzyme/Angiotensin II Receptor Blockers. Other exclusion criteria relate to the required ability to communicate with providers and provide informed consent: prevalent dementia, impaired cognition or severe mental illness; expected life expectancy <6 months; severe visual impairment in the absence of an available caretaker who can read.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02059408

Contacts
Contact: Carmen Peralta, MD, MAS 415-221-4810
Contact: Erica Day, MPH 415-221-4810 ext 3383 erica.day@va.gov

Locations
United States, California
San Francisco Veteran Affairs Medical Center Not yet recruiting
San Francisco, California, United States, 94121
Contact: Carmen A Peralta, MD, MAS    415-221-4810      
Contact: Erica Day, MPH    415-221-4810 ext 3382    erica.day@va.gov   
Principal Investigator: Carmen Peralta, MD, MAS         
Sponsors and Collaborators
University of California, San Francisco
Investigators
Principal Investigator: Carmen A Peralta, MD, MAS San Francisco Veterans Affairs Medical Center
Study Director: Erica Day, MPH San Francisco Veterans Affairs Medical Center
  More Information

No publications provided

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT02059408     History of Changes
Other Study ID Numbers: CP2014R34
Study First Received: January 17, 2014
Last Updated: September 4, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Hypertension
Kidney Diseases
Renal Insufficiency, Chronic
Cardiovascular Diseases
Renal Insufficiency
Urologic Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on November 25, 2014