Improving Albuminuria Screening Compliance Using a Smartphone Urinalysis Kit

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

Detailed Description
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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).

Official Title
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Improving Albuminuria Screening Compliance Using a Smartphone Urinalysis Kit in the Hypertensive Non-Diabetic Population

Conditions
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Albuminuria, Chronic Kidney Diseases, Cardiovascular Diseases, Hypertension

Intervention / Treatment
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* Other: Mailed Urinalysis Smartphone Kit


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control - usual care<br>This arm will receive usual care. | |
| Experimental: Mailed Urinalysis Smartphone Kit<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Completion of albuminuria screening | Includes completion of mailed smartphone urinalysis and clinical labs (urinalysis, albumin/creatinine ratio, or protein/creatinine ratio) | Baseline to 3 months of enrollment date | 
| Total number of detected albuminuria cases | confirmed by urine albumin/creatinine ratio >= 30 mg/g | Baseline to 3 months of enrollment date |