Cardiovasular disease kidney disease
Conditions
Interventions
Subjects will be 1:1 randomized using a computer generated algorithm into group
A or group B. Participants randomized to group A will receive the PeeSpot urine
collection device (Hessels+Grob B.V.,
Hessels et al.
2011) (see Appendix D). This device consists of a holder containing a urine
collection pad, which is an absorption felt containing a dried hygroscopic
polymer. When subjects urinate
Sponsors
Universitair Medisch Centrum Groningen
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Individuals aged 45-80 years - Living in the region of Breda, the Netherlands
Exclusion criteria
Exclusion criteria: - Individuals younger than 45 years or older than 80 years - Not living in the region of Breda, the Netherlands
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| * Participation rate of the two different screening techniques (PeeSpot vs. ACR | EU). * Yield of albuminuria screening from both screening methods (PeeSpot vs. ACR | EU): - number of subjects with elevated albuminuria, - number of subjects with elevated albuminuria and with newly diagnosed risk factors including hypertension, diabetes, hypercholesterolemia, and impaired kidney function) | — |
Secondary
| Measure | Time frame |
|---|---|
| * Completion rate of the study: number of persons completing the study (ACR testing, elaborate screening when invited) relative to the number of all invited persons in the corresponding arm. * Completion and GP follow-up rate study: the number of persons completing the study (ACR testing, elaborate screening when invited, and visiting GP when recommended) relative to the number of all invited persons in the corresponding arm). * Usability of the two different screening techniques (PeeSpot vs. ACR | EU): - User preference: does the participant prefer doing this urine test (either PeeSpot or ACR | EU test) at home or does the participant prefer going to the doctor's office and doing a standard urine test (urinate in cup) there. - Satisfaction rank: how likely is it that the participant would recommend this test to other for urine testing (5-points Likert scale question: very likely / likely / neutral / unlikely / very unlikely). - Percentage that described the process as easy (5-points Likert scale question: very easy / easy / neutral / difficult / very difficult). - Usability success: measured as share or people that tried to do a test that actually succeeded. * Characteristics of the participants of the two different screening methods (PeeSpot vs. ACR | EU) including differences in age, sex, social economic status, medication use, and history of disease. * Incremental cost-effectiveness ratio (ICER) in euro per QALY gained for both screening methods (PeeSpot vs. ACR | EU). * The differences in rate of previously undiagnosed risk factors (hypertension, diabetes, hypercholesterolemia, and impaired kidney function) that were found at the elaborate screening between subjects who have albuminuria and subjects without albuminuria. | — |
Countries
Netherlands
Outcome results
None listed