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Towards HOMe-based Albuminuria Screening: an Implementation Study Testing Two Approaches (THOMAS)

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ClinicalTrials.gov Identifier: NCT04295889
Recruitment Status : Enrolling by invitation
First Posted : March 5, 2020
Last Update Posted : April 5, 2022
Sponsor:
Collaborators:
Dutch Kidney Foundation
E-Zorg B.V. / KPN Health
Healthy.io Ltd.
Hessels+Grob
Copernicus Interchange Technology B.V.
Amphia Hospital
Information provided by (Responsible Party):
dr. R.T. Gansevoort, University Medical Center Groningen

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

Condition or disease Intervention/treatment Phase
Albuminuria Diagnostic Test: Approach A (PeeSpot urine collection device). Diagnostic Test: Approach B (ACR | EU Test kit). Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15032 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Towards HOMe-based Albuminuria Screening: an Implementation Study Testing Two Approaches
Actual Study Start Date : November 14, 2019
Estimated Primary Completion Date : April 1, 2022
Estimated Study Completion Date : July 1, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Group A
Group A will receive an invitation for home based albuminuria screening using a more conventional urine collection device (known as "Peespot Test").
Diagnostic Test: 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.

Active Comparator: Group B
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").
Diagnostic Test: 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.




Primary Outcome Measures :
  1. 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.

  2. 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.


  3. 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;


Secondary Outcome Measures :
  1. GP follow-up rate. [ Time Frame: Screening period of 6 months. ]
    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.

  2. Characteristics of responders. [ Time Frame: Screening period of 6 months. ]
    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

  3. Characteristics of non-responders. [ Time Frame: Screening period of 6 months. ]
    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.

  4. Usability scores of the two screening methods. [ Time Frame: 6 months follow-up after screening period. ]
    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.


Other Outcome Measures:
  1. Appropriate treatment after elaborate screening. [ Time Frame: 6 months follow-up after screening period. ]
    Evaluate whether the subjects who participated the elaborate screening and in which abnormalities were found (hypertension, diabetes, hypercholesterolemia, impaired renal function) did visit their general practitioner for start of appropriate treatment (lifestyle advice and/or medication).

  2. Information regarding sensitivity and specificity of the home-based screening tests [ Time Frame: Screening period of 6 months. ]
    Information on rate of false-negative and -positive tests for both screening methods (PeeSpot vs. ACR | EU).

  3. Optimal cut-off value of albuminuria. [ Time Frame: 6 months follow-up after screening period. ]
    To investigate which cut-off value of albuminuria should be used in the screening to render the most effective screening.

  4. Optimal age range for albuminuria screening. [ Time Frame: 6 months follow-up after screening period. ]
    Investigate the most effective age range for albuminuria screening.

  5. Role of health literacy in albuminuria screening. [ Time Frame: 6 months follow-up after screening period. ]
    The role of health literacy (assessed by questionnaire) in participating in the screening program and by obtaining appropriate treatment by the GP.



Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 45 to 80 years.
  • Living in the municipality of Breda, The Netherlands.
  • Not institutionalised.

Exclusion Criteria:

  • 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).


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04295889


Locations
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Netherlands
University Medical Centre Groningen
Groningen, Netherlands, 9700 RB
Sponsors and Collaborators
University Medical Center Groningen
Dutch Kidney Foundation
E-Zorg B.V. / KPN Health
Healthy.io Ltd.
Hessels+Grob
Copernicus Interchange Technology B.V.
Amphia Hospital
Investigators
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Principal Investigator: Ron T Gansevoort, MD, PhD University Medical Center Groningen
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Responsible Party: dr. R.T. Gansevoort, Professor of Medicine, University Medical Center Groningen
ClinicalTrials.gov Identifier: NCT04295889    
Other Study ID Numbers: LSHM17076-SGF
First Posted: March 5, 2020    Key Record Dates
Last Update Posted: April 5, 2022
Last Verified: March 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by dr. R.T. Gansevoort, University Medical Center Groningen:
albuminuria
chronic kidney disease
cardiovascular disease
population screening
home based
e-Health
app
hypertension
diabetes mellitus
hypercholesterolemia
Additional relevant MeSH terms:
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Albuminuria
Proteinuria
Urination Disorders
Urologic Diseases
Urological Manifestations