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Completed

NCT Number: NCT03470701

Improving Albuminuria Screening Compliance Using a Smartphone Urinalysis Kit

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

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Key information

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Mailed Urinalysis Smartphone Kit

Other

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.

Primary outcomes

  1. Completion of albuminuria screening

    Time frame: Baseline to 3 months of enrollment date

    Includes completion of mailed smartphone urinalysis and clinical labs (urinalysis, albumin/creatinine ratio, or protein/creatinine ratio)

  2. Total number of detected albuminuria cases

    Time frame: Baseline to 3 months of enrollment date

    confirmed by urine albumin/creatinine ratio >= 30 mg/g

Sponsors and collaborators

Lead sponsor

Geisinger Clinic

Other

Collaborators

  • Healthy.io Ltd.
  • National Kidney Foundation, United States

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Mar 20, 2018
Registry last updated
Jul 24, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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