Primary objectives:To perform a study to:1. Estimate the prevalence of elevated albuminuria in subjects with a high risk of chronic kidney disease in the Netherlands.2. Evaluate which screening approach would be most effective based on costs per…
ID
Source
Brief title
Condition
- Nephropathies
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
1. Elevated albuminuria, defined as a urinary albumin creatinine ratio (UACR) >=
3.0 mg/mmol.
2. Average screening costs per subject that was identified as having elevated
albuminuria. All costs considered are mentioned in chapter 8.1.1.
Secondary outcome
1. Unrecognized chronic kidney disease, defined as elevated albuminuria, not
reported by the subject or previously recorded in electronic medical records of
the subjects* general practice or pharmacy.
2. Persistent elevated albuminuria, defined as elevated albuminuria persisting
despite good adherence (score 4 (=doses seldom missed) or 5 (= doses never
missed) reported in MARS) to treatment with RAS-inhibitors for at least 6 weeks
prior to elevated albuminuria assessment
3. Change in frequency of cardiovascular risk factor monitoring, defined as
the difference between the frequency of cardiovascular risk factor monitoring
in participants 3 years before and 6 months after targeted albuminuria
screening.
4. Changes in cardiometabolic drug prescriptions, defined as changes in any
prescription for cardiovascular disease or CKD 6 months after targeted
albuminuria screening compared to three years before.
Background summary
Kidney disease, cardiovascular disease and Diabetes Mellitus are closely
interrelated. Reducing modifiable cardiovascular risk factors has an effect on
preventing both cardiovascular and renal damage. Early detection and
appropriate treatment of kidney disease is important as this may prevent future
cardiovascular complications and end-organ damage more effectively than
intervention in more advanced stages of disease. There is a well-established
relationship between albuminuria and renal- and cardiovascular disease.
Elevated albuminuria has a relatively high prevalence in the general population
(5-9%). The prevalence of albuminuria is even higher in patients with type 2
Diabetes Mellitus (20-40%) and in patients with hypertension (10-15%). Adequate
treatment of albuminuria, preferable at early stages can prevent both
cardiovascular and renal disease progression. However, scarce epidemiological
data show that albuminuria measurements are only conducted in a minority of
individuals and disease recognition is suboptimal, even in high-risk groups.
This leaves a large proportion of patients not identified, and thus not
adequately treated. The current study aims to evaluate if and how early
identification of chronic kidney disease by targeted screening of albuminuria
levels is feasible in primary care (pharmacies and general practitioners) to
optimally discover and treat patients with elevated albuminuria.
Study objective
Primary objectives:
To perform a study to:
1. Estimate the prevalence of elevated albuminuria in subjects with a high risk
of chronic kidney disease in the Netherlands.
2. Evaluate which screening approach would be most effective based on costs per
identified patient with elevated albuminuria, via pharmacies or general
practices.
Secondary objectives:
1. To estimate the prevalence of unrecognized chronic kidney disease in
subjects with a high risk of chronic kidney disease.
2. To estimate the prevalence of persistent elevated albuminuria under adequate
treatment with renin-angiotensin system (RAS) inhibitors in subjects with a
high risk of chronic kidney disease.
3. To assess frequency of cardiovascular risk monitoring by general
practitioners after targeted albuminuria screening.
4. To assess changes in cardio-metabolic drug prescriptions after targeted
screening.
Study design
Cross-sectional study in Dutch pharmacies and general practices.
Study burden and risks
All selected subjects will be asked to participate on a free-will base and to
send a signed informed consent form with a completed short questionnaire to
GPRI. They will be asked to collect urine using the PeeSpot and to send this to
a laboratory by postal mail for a measurement of albuminuria. Subjects will be
informed about the results and, only in case of elevated albuminuria levels,
the subject will be asked to repeat the procedure for a confirmational
measurement. If the confirmational measurement is negative, a third measurement
is needed. If recent (<11 months ago) albuminuria levels were available from
the general practice and found to be elevated as well, a second confirmational
PeeSpot measurement will not be needed. If recent albuminuria levels were not
elevated, subjects will not be approached for this study.
When albuminuria is confirmed, treatment status will be reviewed and
cardiovascular risk factors will be assessed during a visit. Length, weight,
blood pressure, heart rate, point of care HbA1c and creatinine will be
measured. Measurements performed during this visit are non-invasive and part of
standard care in general practice and therefore not associated with additional
risks. A benefit for the patient could be that elevated albuminuria may be
detected earlier because of the screening, and thus comes with health benefits,
such as adequate treatment of impaired renal function and medication monitoring
by the pharmacy, which has been proven to be effective in preventing adverse
events of medication.
Professor Enno Dirk Wiersmastraat 5
Groningen 9713GH
NL
Professor Enno Dirk Wiersmastraat 5
Groningen 9713GH
NL
Listed location countries
Age
Inclusion criteria
Diabetes Mellitus (diagnosis or prescription for the disease based on the NHG
guidelines)
Adipositas (diagnosis)
Hypertension (diagnosis or prescription for the disease based on the NHG
guidelines)
Cardiovascular disease (diagnosis, specified in protocol section 4.2.2)
Lipid disorder (diagnosis or prescription for the disease based on the NHG
guidelines)
Age 45-80 years
Exclusion criteria
Pregnancy
Inability to write or understand the informed consent form
Known normal (<3mg/mmol) albuminuria status within 18 months prior
Design
Recruitment
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 |
---|---|
CCMO | NL78748.056.21 |