Improving Albuminuria Screening Compliance Using a Smartphone Urinalysis Kit
1 other identifier
interventional
999
1 country
1
Brief Summary
This study will test the effectiveness of mailed, smartphone urinalysis kits to improve albuminuria screening compliance and detection of albuminuria.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2018
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 13, 2018
CompletedStudy Start
First participant enrolled
March 19, 2018
CompletedFirst Posted
Study publicly available on registry
March 20, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 19, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
June 19, 2018
CompletedJuly 24, 2018
July 1, 2018
3 months
March 13, 2018
July 23, 2018
Conditions
Outcome Measures
Primary Outcomes (2)
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
Total number of detected albuminuria cases
confirmed by urine albumin/creatinine ratio \>= 30 mg/g
Baseline to 3 months of enrollment date
Study Arms (2)
Control - usual care
NO INTERVENTIONThis arm will receive usual care.
Mailed Urinalysis Smartphone Kit
EXPERIMENTALThis arm will receive a mailed urinalysis smartphone kit if they do not complete albuminuria screening after the initial reminder to do so.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Geisinger Cliniclead
- National Kidney Foundation, United Statescollaborator
- Healthy.io Ltd.collaborator
Study Sites (1)
Geisinger Health System
Danville, Pennsylvania, 17821, United States
Related Publications (1)
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.
PMID: 30999886DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Alex R Chang, MD
Geisinger Clinic
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- SCREENING
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
March 13, 2018
First Posted
March 20, 2018
Study Start
March 19, 2018
Primary Completion
June 19, 2018
Study Completion
June 19, 2018
Last Updated
July 24, 2018
Record last verified: 2018-07