Improving Albuminuria Screening Compliance Using a Smartphone Urinalysis Kit

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)
Estimated Enrollment :	1000 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Screening
Official Title:	Improving Albuminuria Screening Compliance Using a Smartphone Urinalysis Kit in the Hypertensive Non-Diabetic Population
Estimated Study Start Date :	April 2018
Estimated Primary Completion Date :	July 2018
Estimated Study Completion Date :	December 2018

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Secondary Outcome Measures :

1. Achievement of optimal albuminuria treatment [ Time Frame: Baseline to 3 months of enrollment date ]
   Among patients with newly detected albuminuria, we will examine whether achievement of optimal albuminuria treatment (ACE or ARB, statin, BP goal <130/80 mmHg) improves at 3 months compared to baseline

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	18 Years and older (Adult, Senior)
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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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Contacts

Contact: Alex R Chang, MD	570-214-9825	achang@geisinger.edu
Contact: Christina Yule, BS	570-214-5233	cmyule@geisinger.edu

Sponsors and Collaborators

Geisinger Clinic

National Kidney Foundation

Healthy.io Ltd.

Investigators

Principal Investigator:	Alex R Chang, MD	Geisinger Clinic

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Alexander Chang, Assistant Professor, Geisinger Clinic
ClinicalTrials.gov Identifier:	NCT03470701 History of Changes
Other Study ID Numbers:	2017-0516
First Posted:	March 20, 2018
Last Update Posted:	March 21, 2018
Last Verified:	March 2018

Studies a U.S. FDA-regulated Drug Product:		No
Studies a U.S. FDA-regulated Device Product:		No

Additional relevant MeSH terms:

Cardiovascular Diseases; Kidney Diseases; Renal Insufficiency, Chronic; Albuminuria; Urologic Diseases	Renal Insufficiency; Proteinuria; Urination Disorders; Urological Manifestations; Signs and Symptoms