Improving Albuminuria Screening Compliance Using a Smartphone Urinalysis Kit

Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03470701
• Other study ID #: 2017-0516
• Status: Completed
• Phase: N/A
• Start date: March 19, 2018
• Est. completion date: June 19, 2018

Study information

• Verified date: July 2018
• Source: Geisinger Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 999
• Est. completion date: June 19, 2018
• Est. primary completion date: June 19, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Albuminuria
• Cardiovascular Diseases
• Chronic Kidney Diseases
• Hypertension
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

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.

Locations

Country	Name	City	State
United States	Geisinger Health System	Danville	Pennsylvania

Sponsors (3)

Lead Sponsor	Collaborator
Geisinger Clinic	Healthy.io Ltd., National Kidney Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Total number of detected albuminuria cases	confirmed by urine albumin/creatinine ratio >= 30 mg/g	Baseline to 3 months of enrollment date