Towards HOMe-based Albuminuria Screening: an Implementation Study Testing Two Approaches
THOMAS
1 other identifier
interventional
15,032
1 country
1
Brief Summary
Chronic Kidney Disease (CKD) is a worldwide major public health problem that is associated with an increased incidence of kidney failure and cardiovascular events, that lead a high burden for affected patients and high costs for society. Symptoms of CKD occur late, when kidney function drops to below 30%. At that time preventive measures will have only limited efficacy. Protein excretion in urine has increasingly been recognized as early marker of CKD, and is often associated with high blood pressure, diabetes, and/or high cholesterol levels. These are all important risk factors for progression of kidney and cardiovascular disease. Population screening for urinary protein loss could detect a considerable number of subjects with yet unknown risk factors for progressive kidney and cardiovascular disease who can benefit of early intervention. However, there is no validated method for population screening yet. The aim is to to develop a home based population screening for elevated urinary protein loss. Two screening methods will be investigated, and yield and cost-effectiveness of these screening methods will be evaluated
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Nov 2019
Typical duration 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
Study Start
First participant enrolled
November 14, 2019
CompletedFirst Submitted
Initial submission to the registry
March 2, 2020
CompletedFirst Posted
Study publicly available on registry
March 5, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2022
CompletedApril 5, 2022
March 1, 2022
2.4 years
March 2, 2020
March 25, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Participation rate of the screening (i.e. home-based screening, elaborate screening and overall screening program)
The participation rate is defined as the number of persons completing the albuminuria screening (i.e. returning the first PeeSpot urine device or scanned the first ACR \| EU urine test strip with use of the app, and in case of an ACR \>30 mg/g in this initial test, also completing the a confirmatory albuminuria screening tests), elaborate screening and overall screening program relative to the invited number of individuals.
Screening period of 6 months.
The yield of albuminuria screening.
These are twofold. First, the yield of the home-based screening is defined as the number of persons who test positive for albuminuria (at least 2 tests positive) relative to the number of persons participating in the corresponding arm (=per-protocol analysis) and of all invited persons in the corresponding arm (intention-to-screen analysis). Second, the yield of the elaborate screening is defined as the number of subjects with increased albuminuria (defined as ACR \>30 mg/g) with newly diagnosed and/or poorly controlled CVD and CKD risk factors. These risk factors, which will be assessed during the elaborate screening, include hypertension, diabetes mellitus, hyperlipidemia, impaired kidney function.
Screening period of 6 months.
Cost-effectiveness of the screening.
Incremental cost-effectiveness ratio (ICER) in euro per QALY gained for the two screening methods;
6 months follow-up after screening period.
Secondary Outcomes (4)
GP follow-up rate.
Screening period of 6 months.
Characteristics of responders.
Screening period of 6 months.
Characteristics of non-responders.
Screening period of 6 months.
Usability scores of the two screening methods.
6 months follow-up after screening period.
Other Outcomes (5)
Appropriate treatment after elaborate screening.
6 months follow-up after screening period.
Information regarding sensitivity and specificity of the home-based screening tests
Screening period of 6 months.
Optimal cut-off value of albuminuria.
6 months follow-up after screening period.
- +2 more other outcomes
Study Arms (2)
Group A
ACTIVE COMPARATORGroup A will receive an invitation for home based albuminuria screening using a more conventional urine collection device (known as "Peespot Test").
Group B
ACTIVE COMPARATORGroup B will receive an invitation for home based albuminuria screening using an app (internet application) and an ACR dipstick test (known as "ACR\| EU Test").
Interventions
The participant will receive the PeeSpot urine collection device (Hessels+Grob B.V., Deventer, The Netherlands), which consists of a holder containing a urine collection pad (consisting of hygroscopic material containing). The holder can be placed back into the tube and can be easily sent to the laboratory by mail. In this urine, albumin, creatinine, and the ACR will be measured in the laboratory of the Amphia hospital.
The participant will receive the ACR \| EU test kit (Healthy.io Ltd, Tel-Aviv- Yafo, Israel), which consists of a urine test strip, a urine cup, a color calibrator and instruction to download a smartphone application. The participants have to download the smartphone application according to the instructions included in the kit. Results will be directly shown to the participant in the app.
Eligibility Criteria
You may qualify if:
- Age 45 to 80 years.
- Living in the municipality of Breda, The Netherlands.
- Not institutionalised.
You may not qualify if:
- Younger than 45 years or older than 80 years.
- Not living in the municipality of Breda, The Netherlands.
- Institutionalised.
- A random sample of 15.032 subjects will be drawn from the population aged 45-80 years from the municipality of Breda by the Dutch Central Bureau for Statistics (CBS).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University Medical Center Groningenlead
- Dutch Kidney Foundationcollaborator
- E-Zorg B.V. / KPN Healthcollaborator
- Healthy.io Ltd.collaborator
- Hessels+Grobcollaborator
- Copernicus Interchange Technology B.V.collaborator
- Amphia Hospitalcollaborator
Study Sites (1)
University Medical Centre Groningen
Groningen, 9700 RB, Netherlands
Related Publications (2)
van Mil D, Kieneker LM, Evers-Roeten B, Thelen MHM, de Vries H, Hemmelder MH, Dorgelo A, van Etten RW, Heerspink HJL, Gansevoort RT. Participation rate and yield of two home-based screening methods to detect increased albuminuria in the general population in the Netherlands (THOMAS): a prospective, randomised, open-label implementation study. Lancet. 2023 Sep 23;402(10407):1052-1064. doi: 10.1016/S0140-6736(23)00876-0. Epub 2023 Aug 16.
PMID: 37597522DERIVEDvan Mil D, Kieneker LM, Evers-Roeten B, Thelen MHM, de Vries H, Hemmelder MH, Dorgelo A, van Etten RW, Heerspink HJL, Gansevoort RT. Protocol for a randomized study assessing the feasibility of home-based albuminuria screening among the general population: The THOMAS study. PLoS One. 2022 Dec 22;17(12):e0279321. doi: 10.1371/journal.pone.0279321. eCollection 2022.
PMID: 36548281DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ron T Gansevoort, MD, PhD
University Medical Center Groningen
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SCREENING
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Medicine
Study Record Dates
First Submitted
March 2, 2020
First Posted
March 5, 2020
Study Start
November 14, 2019
Primary Completion
April 1, 2022
Study Completion
July 1, 2022
Last Updated
April 5, 2022
Record last verified: 2022-03
Data Sharing
- IPD Sharing
- Will not share