COGNITIVE-HD study: protocol of an observational study of neurocognitive functioning and association with clinical outcomes in adults with end-stage kidney disease treated with haemodialysis

IntroductionThe prevalence of cognitive impairment may be increased in adults with end-stage kidney disease compared with the general population. However, the specific patterns of cognitive impairment and association of cognitive dysfunction with activities of daily living and clinical outcomes (inc...

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Published in:BMJ open 2015-12, Vol.5 (12), p.e009328-e009328
Main Authors: Palmer, Suetonia C, Ruospo, Marinella, Barulli, Maria Rosaria, Iurillo, Annalisa, Saglimbene, Valeria, Natale, Patrizia, Gargano, Letizia, Murgo, Angelo M, Loy, Clement, van Zwieten, Anita, Wong, Germaine, Tortelli, Rosanna, Craig, Jonathan C, Johnson, David W, Tonelli, Marcello, Hegbrant, Jörgen, Wollheim, Charlotta, Logroscino, Giancarlo, Strippoli, G F M
Format: Article
Language:English
Subjects:
Activities of Daily Living
Adolescent
Adult
Alzheimer's disease
Cause of Death
Clinical outcomes
Clinical Protocols
Cognition
Cognition Disorders - etiology
Cognitive ability
Education
Epidemiology
Executive Function
Heart attacks
Humans
Informed consent
Institutionalization
Italy
Kidney diseases
Kidney Failure, Chronic - complications
Kidney Failure, Chronic - mortality
Kidney Failure, Chronic - psychology
Kidney Failure, Chronic - therapy
Language
Learning
Longitudinal Studies
Memory
Mental depression
Mortality
Motor Skills
Neuropsychological Tests
Neuropsychology
Patient Dropouts
Patients
Peritoneal dialysis
Prospective Studies
Renal Dialysis
Research Design
Stroke
Treatment Outcome
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Summary:IntroductionThe prevalence of cognitive impairment may be increased in adults with end-stage kidney disease compared with the general population. However, the specific patterns of cognitive impairment and association of cognitive dysfunction with activities of daily living and clinical outcomes (including withdrawal from treatment) among haemodialysis patients remain incompletely understood. The COGNITIVE impairment in adults with end-stage kidney disease treated with HemoDialysis (COGNITIVE-HD) study aims to characterise the age-adjusted and education-adjusted patterns of cognitive impairment (using comprehensive testing for executive function, perceptual-motor function, language, learning and memory, and complex attention) in patients on haemodialysis and association with clinical outcomes.Methods and analysisA prospective, longitudinal, cohort study of 750 adults with end-stage kidney disease treated with long-term haemodialysis has been recruited within haemodialysis centres in Italy (July 2013 to April 2014). Testing for neurocognitive function was carried out by a trained psychologist at baseline to assess cognitive functioning. The primary study factor is cognitive impairment and secondary study factors will be specific domains of cognitive function. The primary outcome will be total mortality. Secondary outcomes will be cause-specific mortality, major cardiovascular events, fatal and non-fatal myocardial infarction and stroke, institutionalisation, and withdrawal from treatment at 12 months.Ethics and disseminationThis protocol was approved before study conduct by the following responsible ethics committees: Catania (approval reference 186/BE; 26/09/2013), Agrigento (protocol numbers 61–62; 28/6/2013), USL Roma C (CE 39217; 24/6/2013), USL Roma F (protocol number 0041708; 23/7/2013), USL Latina (protocol number 20090/A001/2011; 12/7/2013), Trapani (protocol number 3413; 16/7/2013) and Brindisi (protocol number 40259; 6/6/2013). All participants have provided written and informed consent and can withdraw from the study at any time. The findings of the study will be disseminated through peer-reviewed journals and national and international conference presentations and to the participants through communication within the dialysis network in which this study is conducted.
ISSN:2044-6055
2044-6055
DOI:10.1136/bmjopen-2015-009328