Improving Albuminuria Screening Compliance Using a Smartphone Urinalysis Kit

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

999 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-19

Study Completion Date

2018-06-19

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.

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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).

Conditions

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Albuminuria Chronic Kidney Diseases Cardiovascular Diseases Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SCREENING

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Control - usual care

This arm will receive usual care.

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type EXPERIMENTAL

Mailed Urinalysis Smartphone Kit

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No