AlbuminuriaNCT03470701
Improving Albuminuria Screening Compliance Using a Smartphone Urinalysis Kit
A study testing Mailed Urinalysis Smartphone Kit in people with Albuminuria and Chronic Kidney Diseases, run by Geisinger Clinic at 1 site in United States.
Trial summary
This study will test the effectiveness of mailed, smartphone urinalysis kits to improve albuminuria screening compliance and detection of albuminuria. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Albuminuria, Chronic Kidney Diseases, Cardiovascular Diseases
- What is being tested?
- Mailed Urinalysis Smartphone Kit
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 999 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Mar 2018to 19 Jun 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
Geisinger Health System
Danville, Pennsylvania, 17821
About this study
Official title: Improving Albuminuria Screening Compliance Using a Smartphone Urinalysis Kit in the Hypertensive Non-Diabetic Population
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).
- Being tested
- Mailed Urinalysis Smartphone Kit
- Medical subject headings
- Albuminuria, Renal Insufficiency, Chronic, Cardiovascular Diseases, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mailed Urinalysis Smartphone KitOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Control - usual care | No intervention | This arm will receive usual care. |
| Mailed Urinalysis Smartphone Kit | Experimental | This arm will receive a mailed urinalysis smartphone kit if they do not complete albuminuria screening after the initial reminder to do so. Receives: Other: Mailed Urinalysis Smartphone Kit |
What is being measured
The primary outcome is the main question the study is designed to answer.
Completion of albuminuria screening
Includes completion of mailed smartphone urinalysis and clinical labs (urinalysis, albumin/creatinine ratio, or protein/creatinine ratio)
Measured: Baseline to 3 months of enrollment date
Total number of detected albuminuria cases
confirmed by urine albumin/creatinine ratio >= 30 mg/g
Measured: Baseline to 3 months of enrollment date
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2018
- Study start19 Mar 2018
- Primary completion19 Jun 2018
- Study completion19 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AlbuminuriaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 999 participants (actual)
Sponsor and investigators
- Lead sponsor
- Geisinger Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- National Kidney Foundation, United States, Healthy.io Ltd.
- Responsible party
- Principal investigator, Alexander Chang, Geisinger Clinic
- Investigators
- Alex R Chang, MD, Principal investigator, Geisinger Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03470701
- Sponsor's protocol ID
- 2017-0516
- Status last verified
- Jul 2018
- First submitted
- 13 Mar 2018
- Last updated
- 24 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: May be available upon request
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
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Albuminuria Screening Compliance Using a Smartphone Urinalysis Kit in the Hypertensive Non-Diabetic Population
- ClinicalTrials.gov ID
- NCT03470701
- Acronym / sponsor ID
- 2017-0516
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 999 participants (actual)
- Lead sponsor
- Geisinger ClinicUniversity, hospital or other
- Collaborators
- National Kidney Foundation, United States, Healthy.io Ltd.
- Study start
- 19 Mar 2018 (actual)
- Primary completion
- 19 Jun 2018 (actual)
- Study completion
- 19 Jun 2018 (actual)
- First posted
- 20 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control - usual care | No intervention | –This arm will receive usual care. |
| Mailed Urinalysis Smartphone Kit | Experimental | Other: Mailed Urinalysis Smartphone KitThis arm will receive a mailed urinalysis smartphone kit if they do not complete albuminuria screening after the initial reminder to do so. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mailed Urinalysis Smartphone KitPatients 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. | Other | Mailed Urinalysis Smartphone Kit |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2018.
- Derived from this study: PubMed 30999886Leddy 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.
- Individual participant dataSharing planned: Undecided. May be available upon request
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Rapid and Simultaneous Initiation of Four Guideline-Directed CKD Therapies (RAPID-CKD)
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Study on the Efficacy and Safety of Initial Combination of Finerenone and Semaglutide in Non-Diabetic Adult Patients With Obesity Complicated by Chronic Kidney Disease With Albuminuria
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alex R Chang, MD principal investigator
Geisinger Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mailed Urinalysis Smartphone Kit in people with Albuminuria and Chronic Kidney Diseases, run by Geisinger Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Completion of albuminuria screening (time frame: Baseline to 3 months of enrollment date). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03470701, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2018.