Screening for Chronic Kidney Disease among Older People across Europe (SCOPE)

The progressive aging of the population in industrialized countries is
accompanied by an increase in the prevalence of chronic diseases, including
CKD. Previous studies showed that age standardized rates of stage 3-5 CKD (i.e.
at least moderate degree of kidney disease) was 6.1% among males and 13.1%
among females in the adult population aged 55-64 years, while the corresponding
figures in the population aged 75-84 years were 33.2% and 41.7%, respectively.
Similarly, the prevalence of eGFR<60 ml/min/1.73m2 increased with age in both
genders, from 1% among subjects aged 18*24 years to more than 30% among people
aged 75 years or more. Thus, CKD has a relevant public health burden in the
older population, resulting in an increased risk of ESRD, morbidity and
mortality. Besides increasing the risk of ESRD, morbidity and mortality, CKD
also affect outcomes relevant to older people. Indeed, reduced estimated
glomerular filtration rate (eGFR) was found associated with lower scores in
subjective physical function and physical activity scales. In the
Cardiovascular Health Study cohort including 5,888 persons aged 65 or more the
cross-sectional prevalence of a limitation in activities of daily living (ADL)
was 12% among participants with CKD compared to 7% among participants without
CKD. Additionally, low eGFR was associated with increased risk of worsening
disability, defined as the loss of 1 or more ADLs over 6-year follow-up, among
community-dwelling older individuals enrolled in the InChianti study. Finally,
a recent systematic review showed that CKD was consistently associated with
increasing frailty or reduced physical function. Additionally, frailty was
associated with a greater than two-fold higher risk of dialysis and/or death in
patients with CKD.
Cognitive impairment has been frequently observed in patients with CKD
especially in older subjects. CKD is related to a wide range of deficits in
cognitive functioning including verbal and visual memory and organization, and
components of executive functioning and fluid intellect. Small vessel disease,
which is known to contribute to the pathophysiology of CKD, can lead to
cerebral ischemic lesions, both in the form of silent or subclinical cerebral
infarcts or white matter lesions, increasing the risk of cognitive decline and
dementia.
Depression is frequently observed in older patients with CKD.This is of great
importance because the presence of depression in CKD is associated with poorer
outcomes such as hospitalizations, progression to dialysis, and increased
morbidity and mortality. About 20%-30% of patients with CKD have clinical
depression. In addition to its negative impact on cognition and mood, CKD may
also affect sensory function. Indeed, CKD is considered a relevant risk factor
for retinal abnormalities which may threaten vision, thus worsening quality of
life and causing dependency.
Nutrition is also a major problem for CKD patients; a decline in kidney
function is usually followed by a spontaneous decrease in energy and protein
intake as well as in anthropometric measures, which in turn may favor the onset
of frailty and disability in older patients. Sarcopenia, defined as a loss of
muscle mass with limited mobility/low muscle function (gait speed and hand grip
strength) is a common finding in older adults and its prevalence rises sharply
with declining kidney function. Cachexia is an important cause of death in
older CKD patients.
Finally, CKD increases the risk of adverse drug reactions (ADRs). When renal
function declines, many drugs or their active metabolites that depend on renal
excretion may accumulate. For this reason, patients with CKD may be more
vulnerable to a given drug effect and may be potentially exposed to an
increased risk of toxicity. For this reason, early detection of CKD also
represents a major step towards reducing risk of ADRs and increasing safety in
older complex patients with multimorbidity and polypharmacy.

(protocol C1. for references)

The specific objectives of the SCOPE project will be:
O1. to assess existing methodologies for CKD screening among older adults using
real-life data from a cohort of 75+ older patients;
O2. to investigate novel and potentially useful application of existing and
innovative biomarkers of CKD in older people;
O3. to evaluate the cost-effectiveness of existing and innovative CKD screening
strategies in a population at high risk of developing kidney function decline
and ESRD (including the novel application of existing biomarkers, the use of
innovative ones, and CGA tools);
O4. to provide evidence for further development of European recommendations and
guidelines, as well as an European education programme in this field.

The SCOPE study will be an observational, multinational, multicenter,
prospective cohort study targeting CKD screening in community-dwelling subjects
aged 75 years or more. Participants will undergo clinical and laboratory
evaluations at the baseline (enrollment), and will be followed up at 12 and 24
months. An intermediate telephone follow-up will be carried out at 6 and 18
months. The study design complies with the Declaration of Helsinki and Good
Clinical Practice Guidelines.

Participation in a clinical study involves a very close scrutiny of health
condition. In general, the results of this study may help to reduce the risk of
end stage renal disease, disability and mortality among older people. Blood
samples can cause mild discomfort such as dizziness, pain, redness or a small
bruise at the puncture site. Rarely this can cause an infection. The potential
risks and impact for the participants are minimal so the benefits outweigh the
potential small disadvantages.

Three hospital visits at baseline, after 12 months and after 24 months,
approximately 1 hour per visit.
The visits are planned as close as possible to the regular visits. The
following activities will be performed:
- Questionnaires: demographics, medical history and medication use, minimal
mental state examination (MMSE), Geriatric depression scale (GDS), Activity of
Daily Living (ADL), Instrumental activities of daily living (IADL), Mini
nutritional assessment (MNA), 24-h dietary recall, history of falls,
socioeconomic status, Quality of Live (Euro-Qol 5D), zarit burden interview,
events (adverse drug reaction, new diagnosis at 12-24 months)
- Physical assessment: height, weight, waist/hip circumference, bloodpressure
and functional vascular properties with Mobil-o-graph ® (Mobil-o-graph only in
the Netherlands = a non-invasive measurement using upper arm cuff), physical
examination, short physical performance battery, bioelectrical impedance
analysis, hand grip strength
- Blood/urine samples, sampling will be performed after fasting for 12 hours
(preferably)

2 phone based follow up (6 and 18 months)
Questionnaires: Activity of Daily Living (ADL), Instrumental activities of
daily living (IADL), healthcare resource consumption, events (adverse drug
reaction, new diagnosis)