Clinical trial NCT03470701: Improving Albuminuria Screening Compliance Using a Smartphone Urinalysis Kit
Official title: Improving Albuminuria Screening Compliance Using a Smartphone Urinalysis Kit in the Hypertensive Non-Diabetic Population
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Albuminuria
Chronic Kidney Diseases
Cardiovascular Diseases
Hypertension
Lead sponsor: Geisinger Clinic
Sponsor class: OTHER
Collaborators: name: National Kidney Foundation, United States
name: Healthy.io Ltd.
First posted: 2018-03-20
Enrollment: 999
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

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).

Eligibility criteria: 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)

Primary outcomes:
measure: Completion of albuminuria screening
timeFrame: Baseline to 3 months of enrollment date
measure: Total number of detected albuminuria cases
timeFrame: Baseline to 3 months of enrollment date
Secondary outcomes:
Other outcomes:
Locations:
city: Danville
country: United States
facility: Geisinger Health System
state: Pennsylvania
Study officials:
affiliation: Geisinger Clinic
name: Alex R Chang, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.