Comparison of physical activity and quality of life in home haemodialysis (HHD) patients versus conventional in-centre haemodialysis (ICHD) patients: the observational, longitudinal, prospective, international, multicentric SeCoIA study protocol

Table 1 Study schedule

collected Data	Inclusion	Monthly visit^a	Quaterly VISIT	End of Study 12 Months^b
Selection Criteria^c	x
Demography^d	x
Social Characteristics^e	x	x	x	x
Medical History	x
Drugs^f	x	x	x	x
Blood pressure^g	x	x	x	x
Weight pre and post dialysis	x	x	x	x
Dialysis characteristics^h	x		x	x
Laboratoryⁱ	x	x	x	x
Synchronization Accelerometer		x	x	x
Hospitalizations/ Complications		x	x	x
Adverse Events		x	x	x
KDQOL, PSQI	x		6-month visit only	x
IRLS (if applicable)	x		6-month visit only	x
End of Study Form^b				x

x: Collected data
^a According to centre/physician standard practice
^b or in case of early termination
^c Written consent, eligibility criteria, date of inclusion visit
^d Age, sex, height, smoking status
^e Professional activity, commute modalities to come to the centre and home- centre distance
^f Iron, erythropoietin stimulating agents, phosphate-binding agents, vitamin D, calcium supplementation, calcimimetics, calcium carbonate, bicarbonates, potassium binders, oral anticoagulants, heparin, antihypertensives, lipid-lowering drugs, glucose lowering drugs, analgesics, drugs related to RLS (ropinirole, pramipexole, rotigotine) and sleep disorders (anxiolytics, muscle relaxants, hypnotics)
^g Blood pressure before / after dialysis (collection of the last 3 available measurements at 3 different days)
^h For ICHD patient: Dialysis method (HD, pre-dilution HDF, post-dilution HDF), total convective volume per session for HDF patients, plasma volume control technique (yes / no); for HDD patients: Training start date, convective volume prescribed per session, dialysate flow
ⁱ Blood: hemoglobin, glycated hemoglobin, calcemia, phosphoremia, PTH, bicarbonates, alkaline phosphatase, ferritin, transferrin saturation, albumin, natremia, predialytic β2microglobulin; urinary assessment with the method of collection (sample, 12 h or 24 h urine): creatinuria, urea, proteinuria, microalbuminuria

ISSN: 1471-2369