ClinicalTrials.gg
CompletedNCT03470701Updated Jul 24, 2018

Improving Albuminuria Screening Compliance Using a Smartphone Urinalysis Kit

An interventional study of Mailed Urinalysis Smartphone Kit in Albuminuria, Chronic Kidney Diseases and Cardiovascular Diseases, sponsored by Geisinger Clinic. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-07-24.

Sponsored by Geisinger Clinic · Not applicable, Interventional, and Screening

Phase
Not applicable
Study type
Interventional
Enrollment
999
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 50 studies in Albuminuria with a site in United States — 9 open to participants now, 11 under way, none of them phase 3. Albuminuria · United States.

Enrollment
5th of 42
999 · median 60
Started
2018
with 1 other
No phase
17 of 50
2 open now
Registered
35th of 50
by date
Lead sponsor
5 of 50
Geisinger Clinic

Among the 50 studies in Albuminuria with a site in United States, this one is the 5th largest by enrollment of the 42 interventional ones that give a count, is one of 2 that started in 2018, is one of 17 with no phase, and was the 35th registered.

Albuminuria

142 studies on the registry are indexed under Albuminuria; 24 are open to participants now.

Browse Albuminuria studies →

Open to participants now

9 of the 50 studies in Albuminuria with a site in United States are open now. Recruiting first, the newest first:

4 more — sign in →

All 9 open studies →

A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →

Who these studies take

Of the 13 Albuminuria studies recruiting now, 4 (31%) set no upper age limit and 5 (38%) stop at 75 or younger; 3 take children under 18; 2 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

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02

Study summary

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

Read the 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).

03

Conditions studied

  • Albuminuria
  • Chronic Kidney Diseases
  • Cardiovascular Diseases
  • Hypertension
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • History of diabetes
  • Receiving dialysis
  • History of kidney transplant
  • \< 15 ml/min/1.73m2
  • Principal investigator or PCP discretion (i.e. concerns about safety, compliance)
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

GFR and eGFR (kidney filtering)

GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².

Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.

05

Study design

Phase
Not applicable
Primary purpose
Screening
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
999 participants (actual)

Study arms

  • 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

Interventions

  • OtherMailed 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.

06

What researchers measure

Primary outcomes

  1. Completion of albuminuria screening

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

    Time frame: Baseline to 3 months of enrollment date

  2. Total number of detected albuminuria cases

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

    Time frame: Baseline to 3 months of enrollment date

07

Study locations

1 site
  • Geisinger Health System
    Danville, Pennsylvania 17821, United States
08

References and documents

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. PubMed 30999886 ↗

Individual participant data

Plan to share: Undecided — May be available upon request

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Mar 2018 to primary completion in Jun 2018, 3 months.

Of 22 interventional studies with no phase under Albuminuria, half reached primary completion within 28 months of starting (the median), counting those still running; a quarter within 21 and three quarters within 48. This study's 3 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 13, 2018
First posted
Mar 20, 2018
StartActual
Mar 19, 2018
Primary completionActual
Jun 19, 2018
CompletionActual
Jun 19, 2018
Last update
Jul 24, 2018
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 24, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03470701
Lead sponsor
Geisinger Clinic
Collaborators
National Kidney Foundation, Healthy.io Ltd.
Responsible party
Alexander Chang (Assistant Professor, Geisinger Clinic) — Principal investigator
First posted
Mar 20, 2018
Start date
Mar 19, 2018
Primary completion
Jun 19, 2018
Completion
Jun 19, 2018
Last update
Jul 24, 2018

Study contacts

Alex R Chang, MD
principal investigator · Geisinger Clinic

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2018. You cannot join it, but the record below documents what was studied.

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