The Check@Home consortium aims to set up a roadmap and infrastructure for a (cost-)effective program to early detect atrial fibrillation and chronic kidney disease (defined by elevated albuminuria) in the general population. Furthermore, the project…
ID
Source
Brief title
Condition
- Cardiac arrhythmias
- Renal disorders (excl nephropathies)
- Diabetic complications
Synonym
Research involving
Sponsors and support
Intervention
- Medical device
N.a.
Outcome measures
Primary outcome
<p>Overall effectiveness of population based screening on atrial fibrillation and<br />
chronic kidney disease (defined by elevated albuminuria) in subjects aged 50-75<br />
years, based on:<br />
- Participation rate of different screening strategies and phases<br />
- Yield of the screening (number of subjects with (newly) diagnosed disease and<br />
risk factors)<br />
- Effectiveness of the different screening and treatment strategies on the main<br />
(combined) endpoint (as defined in protocol section 10.1), compared to standard<br />
care </p>
Secondary outcome
<p>Overall effectiveness of population based screening on heart failure, coronary<br />
artery disease, and diabetes type 2 in subjects aged 50-75 years, based on:<br />
- Effectiveness of different screening and treatment strategies on other<br />
cardiovascular events, compared to standard care<br />
- Cost-effectiveness of different screening strategies, compared to standard<br />
care<br />
- Safety of the atrial fibrillation screening and treatment program, compared<br />
to standard care</p>
Background summary
Currently, in the Netherlands there is no structured national approach for the
early detection of cardiovascular disease, kidney disease, and type 2 diabetes
in the general population, despite the social and economic impact of these
disorders. Detecting these chronic conditions at an early stage could allow for
adequate and early treatment to prevent the progression of these conditions and
their complications, thereby reducing the societal and economic burden caused
by these chronic diseases.
Study objective
The Check@Home consortium aims to set up a roadmap and infrastructure for a
(cost-)effective program to early detect atrial fibrillation and chronic kidney
disease (defined by elevated albuminuria) in the general population.
Furthermore, the project aims to examine options for treatment of these
diseases, as well as options for broader screening, including the early
detection of heart failure, coronary arterty disease, and diabetes type 2.
Study design
This will be a population-based screening with a phased implementation and an
iterative design in four regions in the Netherlands (Breda, Utrecht, Arnhem,
Eindhoven). The overall screening program will consist of three phases: a
home-based testing phase, diagnostic screening phase, and a treatment phase.
Subjects will be invited for a home-based screening (phase 1) that includes
home-based testing; urine collection for detection of elevated albuminuria, and
a heart rhythm measurement using a smartphone app for detection of atrial
fibrillation. Both home-based tests will be performed with CE-marked medical
devices used according to their intended use. In subsets of the population,
alternative, more exploratory home-based screening tests will be implemented.
Depending on the results on these home-based tests, subjects will be invited
for further screening in a diagnostic screening facility (phase 2). During this
visit, physical data (height, weight, waist circumference, blood pressure,
heart rhythm) will be collected, blood will be drawn, and urine will be
collected for the assessment of parameters that are indicative of a
cardiovascular disease, chronic kidney disease, type 2 diabetes or their risk
factors. Participants will receive a questionnaire that include questions on
demographics, educational level, disease history, medication use, health
literacy, and quality of life. Based on the results of the diagnostic
screening, participants may be referred to their general practitioner for
appropriate treatment (lifestyle advice/medication) according to the prevailing
guidelines (phase 3).
Intervention
Two medical devices will be used in the home-based screening phase of this study. These devices are CE-marked and will be used according to their intended use.
- PeeSpot urine collection device: The PeeSpot urine collection device consists of a holder containing a urine absorption pad in a transport tube. The urine absorption pad is an absorption felt containing a dried hygroscopic polymer. For collecting a portion of urine with the PeeSpot, the absorbent pad is held in the urine stream for 3-5 seconds, in which approximately 1.2 ml of urine is absorbed. The holder can be placed back into the tube and can be sent to the laboratory by mail. Because of the dried preservative in the urine absorption felt, the urine has a preservation capacity of 4 days at room temperature. In the laboratory, the tube can be centrifuged and the urine will be released into the tube. In this urine, the ACR can be measured. The PeeSpots will be measured by the Star-shl laboratory (Rotterdam). The PeeSpot urine collection device is registered as medical device class I. For more details, see “D2.2 Medical device information PeeSpot”.
- Happitech SDK: With the Happitech software, participants monitor their heart rate and heart rate variability with use of photoplethysmography (PPG) and powered by AI algorithms. PPG is a non-invasive way to detect volumetric changes in blood in peripheral circulation. Blood absorbs light and each pulse from the heart increases the blood flow in the body and to the fingertips. It is possible to keep track of changes in this pulse by measuring changes in light absorption. Users are guided by voice instructions to place their fingertip on the correct part of the smartphone camera lens for 90 seconds during which time the heart rhythm is detected. The Happitech heart rhythm Software Development Kit is CE Certified and classified as a Class IIa device under the MDD (93/42/EEC). For more details, see “D2.3 Medical device information Happitech”.
Study burden and risks
Physical risks of the overall screening program are minimal. As with any
population screening program, there could be some physiological discomfort
associated with participation: confrontation with unfavorable results,
unnecessary anxiety in case of false-positive test results, and unwarranted
reassurance in case of false-negative results. The benefit of participation
would be that cardiovascular disease, chronic kidney disease, type 2 diabetes
or their risk factors may be detected in an early phase, allowing for early
treatment of these conditions and therefore a reduced risk of disease
progression and complications.
L.M. Kieneker
Hanzeplein 1
Groningen 9713GZ
Netherlands
050-3611114
info@checkathome.nl
L.M. Kieneker
Hanzeplein 1
Groningen 9713GZ
Netherlands
050-3611114
info@checkathome.nl
Trial sites in the Netherlands
Listed location countries
Age
Inclusion criteria
age 50-75 years
living in one of the four participating regions in the Netherlands
Exclusion criteria
age <50 or >75 years living outside the participating regions being
institutionalized having participated in the previously conducted THOMAS Study
(NL65228.042.18, METc 2018/687)
Design
Recruitment
Medical products/devices used
IPD sharing statement
Plan description
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT06330480 |
| CCMO | NL84419.042.23 |
| Research portal | NL-006099 |