Improving Albuminuria Screening Compliance Using a Smartphone Urinalysis Kit

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03470701

Enrollment

999

Registered

2018-03-20

Start date

2018-03-19

Completion date

2018-06-19

Last updated

2018-07-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Albuminuria, Cardiovascular Diseases, Chronic Kidney Diseases, Hypertension

Brief summary

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

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).

Interventions

OTHERMailed 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SCREENING

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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)

Design outcomes

Primary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 21, 2026