Improving Albuminuria Screening Compliance Using a Smartphone Urinalysis Kit
Primary Purpose
Albuminuria, Chronic Kidney Diseases, Cardiovascular Diseases
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mailed Urinalysis Smartphone Kit
Sponsored by
About this trial
This is an interventional screening trial for Albuminuria
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)
Sites / Locations
- Geisinger Health System
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Control - usual care
Mailed Urinalysis Smartphone Kit
Arm Description
This arm will receive usual care.
This arm will receive a mailed urinalysis smartphone kit if they do not complete albuminuria screening after the initial reminder to do so.
Outcomes
Primary Outcome Measures
Completion of albuminuria screening
Includes completion of mailed smartphone urinalysis and clinical labs (urinalysis, albumin/creatinine ratio, or protein/creatinine ratio)
Total number of detected albuminuria cases
confirmed by urine albumin/creatinine ratio >= 30 mg/g
Secondary Outcome Measures
Full Information
NCT ID
NCT03470701
First Posted
March 13, 2018
Last Updated
July 23, 2018
Sponsor
Geisinger Clinic
Collaborators
National Kidney Foundation, Healthy.io Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT03470701
Brief Title
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
2. Study Status
Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
March 19, 2018 (Actual)
Primary Completion Date
June 19, 2018 (Actual)
Study Completion Date
June 19, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Geisinger Clinic
Collaborators
National Kidney Foundation, Healthy.io Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Albuminuria, Chronic Kidney Diseases, Cardiovascular Diseases, Hypertension
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
999 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control - usual care
Arm Type
No Intervention
Arm Description
This arm will receive usual care.
Arm Title
Mailed Urinalysis Smartphone Kit
Arm Type
Experimental
Arm Description
This arm will receive a mailed urinalysis smartphone kit if they do not complete albuminuria screening after the initial reminder to do so.
Intervention Type
Other
Intervention Name(s)
Mailed Urinalysis Smartphone Kit
Intervention Description
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 Outcome Measure Information:
Title
Completion of albuminuria screening
Description
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
Title
Total number of detected albuminuria cases
Description
confirmed by urine albumin/creatinine ratio >= 30 mg/g
Time Frame
Baseline to 3 months of enrollment date
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alex R Chang, MD
Organizational Affiliation
Geisinger Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Geisinger Health System
City
Danville
State/Province
Pennsylvania
ZIP/Postal Code
17821
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
May be available upon request
Citations:
PubMed Identifier
30999886
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.
Results Reference
derived
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Improving Albuminuria Screening Compliance Using a Smartphone Urinalysis Kit
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