AlbuminuriaTHOMASNCT04295889
Towards HOMe-based Albuminuria Screening: an Implementation Study Testing Two Approaches
A study testing Approach A (PeeSpot urine collection device). and Approach B (ACR | EU Test kit). in people with Albuminuria, run by University Medical Center Groningen at 1 site in Netherlands.
Trial 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%. Read more about this study
- Who is it for?
- Ages 45 to 80 years
- Conditions the study is for
- Albuminuria
- What is being tested?
- Approach A (PeeSpot urine collection device). and Approach B (ACR | EU Test kit).
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15,032 participants
- Where
- 1 siteNetherlands
- Study dates
- 14 Nov 2019to 1 Jul 2022
- 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 45 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 45 to 80 years.
- Living in the municipality of Breda, The Netherlands.
- Not institutionalised.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
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
Read the detailed description
Chronic kidney disease (CKD) is a worldwide major public health problem that is associated with an increased incidence of kidney failure and cardiovascular disease (CVD). To tackle this burden, screening for CKD among the general population could be beneficial to allow early detection and treatment. In the last decades, elevated albuminuria has increasingly been recognized as an early marker of generalized vascular endothelial damage, that predicts CKD and CVD progression.
It has been estimated that approximately 6% of the general population has elevated albuminuria, and that the majority of these subjects are not known yet with this abnormality. Among these subjects, many have hypertension, hyperlipidemia, diabetes and/or impaired kidney function, that often is also not known yet. Early detection of elevated albuminuria may be important because it gives the opportunity to invite subjects that test positive for further screening for CKD and CVD risk factors. Thus these risk factors for CKD and CVD progression could be treated in an early stage.
Population screening for albuminuria could be justified according to the WHO criteria of Wilson and Jungner , because CKD has important consequences for subjects, the course of the disease is initially symptomless, and there are treatment methods available. However, implementation research to validate screening the general population for albuminuria and related health consequences is lacking, as are cost-effectiveness studies.
In the current study the aim is to develop a home-based screening technique for detecting elevated albuminuria. Two screening methods will be investigated, and yield and cost-effectiveness of these screening methods will be evaluated
- Conditions
- Albuminuria
- Being tested
- Approach A (PeeSpot urine collection device)., Approach B (ACR | EU Test kit).
- Keywords
- albuminuria, chronic kidney disease, cardiovascular disease, population screening, home based, e-Health, app, hypertension, diabetes mellitus, hypercholesterolemia
- Medical subject headings
- Albuminuria, Renal Insufficiency, Chronic, Cardiovascular Diseases, Alzheimer Disease, Hypertension, Diabetes Mellitus, Hypercholesterolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Approach A (PeeSpot urine collection device).Diagnostic test
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.
Approach B (ACR | EU Test kit).Diagnostic test
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.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Active comparator | Group A will receive an invitation for home based albuminuria screening using a more conventional urine collection device (known as "Peespot Test"). Receives: Diagnostic Test: Approach A (PeeSpot urine collection device). |
| Group B | Active comparator | Group 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"). Receives: Diagnostic Test: Approach B (ACR | EU Test kit). |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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;
Measured: 6 months follow-up after screening period.
Secondary outcomes (4)
GP follow-up rate.
Number of persons completing the complete study (ACR testing, elaborate screening when invited, and visiting GP when recommended) relative to the number of referred individuals.
Measured: Screening period of 6 months.
Characteristics of responders.
Information on (differences in) characteristics of the responders of the two screening methods (PeeSpot vs. ACR | EU) including differences in age, sex, educational level, estimated social economic status (based on data of Statistics Netherlands, providing estimated social economic status based on postal codes), medication use, and history of disease
Measured: Screening period of 6 months.
Characteristics of non-responders.
Information on (differences in) characteristics of the non-responders of the two screening methods (PeeSpot vs. ACR | EU) including differences in age, sex, and estimated social economic status.
Measured: Screening period of 6 months.
Usability scores of the two screening methods.
Usability of both tests assessed by questionnaire in the participants with a confirmed positive test and in a subgroup of participants with a negative test.
Measured: 6 months follow-up after screening period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2020
- Study start14 Nov 2019
- Primary completion1 Apr 2022 (estimated)
- Study completion1 Jul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- None (open label)
- Enrolment
- 15,032 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Collaborators
- Dutch Kidney Foundation, E-Zorg B.V. / KPN Health, Healthy.io Ltd., Hessels+Grob, Copernicus Interchange Technology B.V., Amphia Hospital
- Responsible party
- Principal investigator, dr. R.T. Gansevoort, University Medical Center Groningen
- Investigators
- Ron T Gansevoort, MD, PhD, Principal investigator, University Medical Center Groningen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04295889
- Sponsor's protocol ID
- LSHM17076-SGF
- Acronym
- THOMAS
- Status last verified
- Mar 2022
- First submitted
- 2 Mar 2020
- Last updated
- 5 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37597522van 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.
PubMed 36548281
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Towards HOMe-based Albuminuria Screening: an Implementation Study Testing Two Approaches
- ClinicalTrials.gov ID
- NCT04295889
- Acronym / sponsor ID
- THOMAS / LSHM17076-SGF
- Conditions
- Albuminuria
- Keywords
- albuminuria, chronic kidney disease, cardiovascular disease, population screening, home based, e-Health, app, hypertension
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15,032 participants (estimated)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Collaborators
- Dutch Kidney Foundation, E-Zorg B.V. / KPN Health, Healthy.io Ltd., Hessels+Grob, Copernicus Interchange Technology B.V., Amphia Hospital
- Study start
- 14 Nov 2019 (actual)
- Primary completion
- 1 Apr 2022 (estimated)
- Study completion
- 1 Jul 2022 (estimated)
- First posted
- 5 Mar 2020 (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.
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
Detailed description
Chronic kidney disease (CKD) is a worldwide major public health problem that is associated with an increased incidence of kidney failure and cardiovascular disease (CVD). To tackle this burden, screening for CKD among the general population could be beneficial to allow early detection and treatment. In the last decades, elevated albuminuria has increasingly been recognized as an early marker of generalized vascular endothelial damage, that predicts CKD and CVD progression.
It has been estimated that approximately 6% of the general population has elevated albuminuria, and that the majority of these subjects are not known yet with this abnormality. Among these subjects, many have hypertension, hyperlipidemia, diabetes and/or impaired kidney function, that often is also not known yet. Early detection of elevated albuminuria may be important because it gives the opportunity to invite subjects that test positive for further screening for CKD and CVD risk factors. Thus these risk factors for CKD and CVD progression could be treated in an early stage.
Population screening for albuminuria could be justified according to the WHO criteria of Wilson and Jungner , because CKD has important consequences for subjects, the course of the disease is initially symptomless, and there are treatment methods available. However, implementation research to validate screening the general population for albuminuria and related health consequences is lacking, as are cost-effectiveness studies.
In the current study the aim is to develop a home-based screening technique for detecting elevated albuminuria. Two screening methods will be investigated, and yield and cost-effectiveness of these screening methods will be evaluated
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Active comparator | Diagnostic Test: Approach A (PeeSpot urine collection device).Group A will receive an invitation for home based albuminuria screening using a more conventional urine collection device (known as "Peespot Test"). |
| Group B | Active comparator | Diagnostic Test: Approach B (ACR | EU Test kit).Group 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"). |
Who may qualify
- Ages
- 45 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 45 to 80 years.
- Living in the municipality of Breda, The Netherlands.
- Not institutionalised.
Key exclusion criteria (4 listed)
- 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).
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 |
|---|---|---|
| Approach A (PeeSpot urine collection device).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. | Diagnostic test | Group A |
| Approach B (ACR | EU Test kit).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. | Diagnostic test | Group B |
Primary outcome
Participation rate of the screening (i.e. home-based screening, elaborate screening and overall screening program)
Time frame: Screening period of 6 months.
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.
The yield of albuminuria screening.
Time frame: Screening period of 6 months.
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.
Cost-effectiveness of the screening.
Time frame: 6 months follow-up after screening period.
Incremental cost-effectiveness ratio (ICER) in euro per QALY gained for the two screening methods;
4 secondary outcomes
GP follow-up rate.
Time frame: Screening period of 6 months.
Characteristics of responders.
Time frame: Screening period of 6 months.
Characteristics of non-responders.
Time frame: Screening period of 6 months.
Usability scores of the two screening methods.
Time frame: 6 months follow-up after screening period.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2022.
- Derived from this study: PubMed 37597522van 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.
- Derived from this study: PubMed 36548281van 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.
- Individual participant dataSharing planned: No
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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.
Ron T Gansevoort, MD, PhD principal investigator
University Medical Center Groningen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Approach A (PeeSpot urine collection device). and Approach B (ACR | EU Test kit). in people with Albuminuria, run by University Medical Center Groningen at 1 site in Netherlands.
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 3 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 5 Apr 2022. 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 Netherlands. 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?
Results are not available in the source record.
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?
Participation rate of the screening (i.e. home-based screening, elaborate screening and overall screening program) (time frame: Screening period of 6 months.). The study lists 3 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 NCT04295889, which also lists 2 linked publications.
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 5 Apr 2022.