Improving proteinuria screening with mailed smartphone urinalysis testing in previously unscreened patients with hypertension: a randomized controlled trial

Abstract

Background: Proteinuria screening is recommended for patients with hypertension to screen for kidney disease and identify those at elevated risk for cardiovascular disease. However, screening rates among hypertensive patients are low. Home testing strategies may be useful in improving proteinuria screening adherence.

Methods: We conducted an individual-level, randomized trial at 55 primary care clinic sites in the Geisinger Health System to evaluate the effectiveness of a strategy using home smartphone urinalysis test (Dip.io) to complete proteinuria screening in previously unscreened non-diabetic patient portal users with hypertension. All patients received an educational letter and a standing urinalysis lab order, and then were randomized to control (usual care) or intervention. Intervention arm participants were invited to complete proteinuria screening with a mailed home smartphone urinalysis test. Co-primary outcomes were completion of proteinuria screening and number of albuminuria cases (albumin/creatinine ratio [ACR] ≥ 30 mg/g or protein/creatinine ratio ≥ 150 mg/g) at the end of 3 months. We also evaluated patient satisfaction with the home test, and compliance with recommendations for patients with newly detected albuminuria.

Results: A total of 999 patients were randomized to intervention or control. Out of 499 patients assigned to the intervention arm, 253 were reached by phone, and 69/97 (71.1%) consented patients completed the home test. Overall, the intervention increased proteinuria screening completion (28.9% vs. 18.0%; p < 0.001) with no effect on the number of albuminuria cases (4 vs. 4) although only 6/57 (10.5%) patients with trace or 1+ urine dipstick protein had a follow-up quantitative test. Among the 55 patients who completed a survey after the home test, 89% preferred testing at home rather than the physician's office.

Conclusions: A strategy using a home urinalysis smartphone test increased proteinuria screening rates in previously unscreened patients with hypertension and may be useful in increasing rates of proteinuria screening compliance. Future studies should evaluate use of home testing kits to screen for and confirm albuminuria, and determine whether improving early detection of kidney disease can improve future kidney health.

Trial registration: Clinical Trial Registry: NCT03470701 (First posted 3/20/2018) https://ichgcp.net/clinical-trials-registry/NCT03470701 . This study was retrospectively registered.

Keywords: Albuminuria; CKD; Chronic kidney disease; Home testing; Proteinuria; Screening; Smartphone; Urinalysis; mHealth.

Conflict of interest statement

Ethics approval and consent to participate

The Geisinger Institutional Review Board (IRB) approved the protocol (2017–0516), including the informed consent procedures which are as follows: Informed consent was obtained verbally for patients in the intervention arm to receive the home testing kit, which was not FDA-approved at the time of the research trial. Verbal consent was obtained as written consent would have required patients to come in person, limiting generalizability. Informed consent was waived for patients in the control arm as patients in the control received routine medical care. This study adheres to CONSORT guidelines (Supplemental Materials).

Consent for publication

Not applicable.

Competing interests

J.C. is on the Scientific Advisory Board for Healthy.io.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1

Dip.io Urinalysis Testing Process. Patients in the intervention arm who provided verbal consent were sent a text message and a link to download the dip.io app from the Apple Store or Google Play. Dip.io tests were then shipped to participants who opened the app, followed directions provided on-screen, collected urine in the provided container, dipped the urinalysis dipstick, placed the dipstick on the color board, and scanned the dipstick and color board using the app. For this project, results were transmitted to a Health Insurance Portability and Accountability Act (HIPAA)-compliant website portal, which was accessed by the research team. Source: The figure was created by the Healthy.io team (Tel Aviv, Israel)

Fig. 2

Study Flow. A total of 999 patients met inclusion/exclusion criteria and were randomized; all were included in analyses. In the control arm, 90/500 (18.0%) completed proteinuria screening tests. In the intervention arm, a total of 144/499 (28.9%) patients completed proteinuria screening tests, including 69 which were completed with the home testing kit