Improving Albuminuria Screening Compliance Using a Smartphone Urinalysis Kit

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

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

Study Overview

• Status: Completed
• Conditions: Cardiovascular Diseases; Hypertension; Chronic Kidney Diseases; Albuminuria
• Intervention / Treatment: Other: Mailed Urinalysis Smartphone Kit

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 Type: Interventional
• Enrollment (Actual): 999
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Danville, Pennsylvania, United States, 17821
      • Geisinger Health System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SCREENING
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Geisinger Clinic
• Collaborators: National Kidney Foundation; Healthy.io Ltd.
• Investigators: Principal Investigator: Alex R Chang, MD, Geisinger Clinic

Publications and helpful links

General Publications

• Leddy J, Green JA, Yule C, Molecavage J, Coresh J, Chang AR. Improving proteinuria screening with mailed smartphone urinalysis testing in previously unscreened patients with hypertension: a randomized controlled trial. BMC Nephrol. 2019 Apr 18;20(1):132. doi: 10.1186/s12882-019-1324-z.

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 19, 2018
• Primary Completion (ACTUAL): June 19, 2018
• Study Completion (ACTUAL): June 19, 2018

Study Registration Dates

• First Submitted: March 13, 2018
• First Submitted That Met QC Criteria: March 13, 2018
• First Posted (ACTUAL): March 20, 2018

Study Record Updates

• Last Update Posted (ACTUAL): July 24, 2018
• Last Update Submitted That Met QC Criteria: July 23, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urologic Diseases; Urological Manifestations; Renal Insufficiency; Urination Disorders; Proteinuria; Cardiovascular Diseases; Kidney Diseases; Renal Insufficiency, Chronic; Albuminuria
• Other Study ID Numbers: 2017-0516

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: May be available upon request

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No