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Improving Albuminuria Screening Compliance Using a Smartphone Urinalysis Kit

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03470701
Recruitment Status : Completed
First Posted : March 20, 2018
Last Update Posted : July 24, 2018
Sponsor:
Collaborators:
National Kidney Foundation
Healthy.io Ltd.
Information provided by (Responsible Party):
Alexander Chang, Geisinger Clinic

Study Description
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Brief Summary:
This study will test the effectiveness of mailed, smartphone urinalysis kits to improve albuminuria screening compliance and detection of albuminuria.

Condition or disease Intervention/treatment Phase
Albuminuria Chronic Kidney Diseases Cardiovascular Diseases Hypertension Other: Mailed Urinalysis Smartphone Kit Not Applicable

Detailed Description:
This proposal will examine the effect of mailed, smartphone urinalysis kits to improve albuminuria screening compliance and detection of albuminuria. The investigators will randomize 1,000 non-diabetic MyGeisinger portal users with hypertension and last clinic blood pressure >= 130/80 mmHg who have not received albuminuria screening to either: 1) control - usual care or 2) intervention - mailed urinalysis smartphone kit. All patients will first receive a reminder letter to have albuminuria screening completed at their clinic in coordination with the Geisinger Care Gap Team. Patients randomized to the intervention arm who do not complete this initial screening test will then be offered a mailed, smartphone urinalysis testing kit. Patients with 1+ or greater detected urine protein will be recommended to have urine albumin/creatinine ratio (ACR) testing to confirm albuminuria. Patients with ACR >= 30 mg/g will be referred to pharmacists for optimal treatment of albuminuria (ACE or ARB, statin, BP goal <130/90 mmHg).
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 999 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Screening
Official Title: Improving Albuminuria Screening Compliance Using a Smartphone Urinalysis Kit in the Hypertensive Non-Diabetic Population
Actual Study Start Date : March 19, 2018
Actual Primary Completion Date : June 19, 2018
Actual Study Completion Date : June 19, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Urinalysis

Arms and Interventions
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Arm Intervention/treatment
No Intervention: Control - usual care
This arm will receive usual care.
Experimental: Mailed Urinalysis Smartphone Kit
This arm will receive a mailed urinalysis smartphone kit if they do not complete albuminuria screening after the initial reminder to do so.
 Other: Mailed Urinalysis Smartphone Kit
Patients who fail to complete albuminuria screening after the initial reminder to do so, will be contacted by phone and offered a mailed smartphone urinalysis kit. Agreeable patients will then receive the mailed kit and instructions to use their smartphone camera to analyze a urine dipstick.


Outcome Measures
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Primary Outcome Measures :
  1. Completion of albuminuria screening [ Time Frame: Baseline to 3 months of enrollment date ]
    Includes completion of mailed smartphone urinalysis and clinical labs (urinalysis, albumin/creatinine ratio, or protein/creatinine ratio)

  2. Total number of detected albuminuria cases [ Time Frame: Baseline to 3 months of enrollment date ]
    confirmed by urine albumin/creatinine ratio >= 30 mg/g


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18 and older
  • Hypertension
  • Last outpatient BP ≥ 130/80 mmHg
  • Active MyGeisinger users with a listed mobile phone number
  • Has a Geisinger PCP and followed by the Care Gaps team
  • No prior urine albuminuria test (urine dipstick, albumin/creatinine ratio, protein/creatinine ratio)

Exclusion Criteria:

  • History of diabetes
  • Receiving dialysis
  • History of kidney transplant
  • eGFR < 15 ml/min/1.73m2
  • Principal investigator or PCP discretion (i.e. concerns about safety, compliance)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03470701


Locations
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United States, Pennsylvania
Geisinger Health System
Danville, Pennsylvania, United States, 17821
Sponsors and Collaborators
Geisinger Clinic
National Kidney Foundation
Healthy.io Ltd.
Investigators
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Principal Investigator: Alex R Chang, MD Geisinger Clinic
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Alexander Chang, Assistant Professor, Geisinger Clinic
ClinicalTrials.gov Identifier: NCT03470701    
Other Study ID Numbers: 2017-0516
First Posted: March 20, 2018    Key Record Dates
Last Update Posted: July 24, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: May be available upon request

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Albuminuria
Cardiovascular Diseases
Urologic Diseases
 Renal Insufficiency
Proteinuria
Urination Disorders
Urological Manifestations
Signs and Symptoms