Improving Albuminuria Screening Compliance Using a Smartphone Urinalysis Kit

Not Applicable

Completed

• Conditions: Cardiovascular Diseases; Albuminuria; Hypertension; Chronic Kidney Diseases
• Interventions: Other: Mailed Urinalysis Smartphone Kit

• Registration Number: NCT03470701
• Lead Sponsor: Geisinger Clinic

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).

Study Timeline

• Study First Submitted: 2018-03-13
• Study First Submitted QC: 2018-03-13
• Study Start: 2018-03-19
• Study First Posted: 2018-03-20
• Primary Completion: 2018-06-19
• Study Completion: 2018-06-19
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-23
• Last Update Posted: 2018-07-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 999

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mailed Urinalysis Smartphone Kit	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.

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Geisinger Health System; 🇺🇸 Danville, Pennsylvania, United States