Improving Albuminuria Screening Compliance Using a Smartphone Urinalysis Kit
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ClinicalTrials.gov Identifier: NCT03470701 |
Recruitment Status :
Completed
First Posted : March 20, 2018
Last Update Posted : July 24, 2018
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Condition or disease | Intervention/treatment | Phase |
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Albuminuria Chronic Kidney Diseases Cardiovascular Diseases Hypertension | Other: Mailed Urinalysis Smartphone Kit | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 999 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Outcomes Assessor) |
Primary Purpose: | Screening |
Official Title: | Improving Albuminuria Screening Compliance Using a Smartphone Urinalysis Kit in the Hypertensive Non-Diabetic Population |
Actual Study Start Date : | March 19, 2018 |
Actual Primary Completion Date : | June 19, 2018 |
Actual Study Completion Date : | June 19, 2018 |

Arm | Intervention/treatment |
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No Intervention: Control - usual care
This arm will receive usual care.
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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.
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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. |
- 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)
- Total number of detected albuminuria cases [ Time Frame: Baseline to 3 months of enrollment date ]confirmed by urine albumin/creatinine ratio >= 30 mg/g

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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)

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03470701
United States, Pennsylvania | |
Geisinger Health System | |
Danville, Pennsylvania, United States, 17821 |
Principal Investigator: | Alex R Chang, MD | Geisinger Clinic |
Responsible Party: | Alexander Chang, Assistant Professor, Geisinger Clinic |
ClinicalTrials.gov Identifier: | NCT03470701 |
Other Study ID Numbers: |
2017-0516 |
First Posted: | March 20, 2018 Key Record Dates |
Last Update Posted: | July 24, 2018 |
Last Verified: | July 2018 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Plan Description: | May be available upon request |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Kidney Diseases Renal Insufficiency, Chronic Albuminuria Cardiovascular Diseases Urologic Diseases |
Renal Insufficiency Proteinuria Urination Disorders Urological Manifestations |