Executability and repeatability of a study setup using wearable and computerized technology to examine a wide range of physiological and cognitive functions of a patient outside hospital

Abstract

ABSTRACTObjectivesReasons for a patient’s daily problems are often unclear as they are not systematically monitored in daily life. To remedy this, we designed a study protocol combining outpatient laboratory and home measurements. Feasibility of the protocol was evaluated by examining its executability and repeatability.ParticipantsSixteen patients undergoing neurosurgery for unruptured intracranial aneurysm (UIA), each acting as one’s own control.Study ProtocolTwo laboratory examinations followed by home recordings at 2 weeks pre- and 4-6 weeks postoperatively. In between a sole home recording at 3 weeks and 3 months postoperatively. Subjective health and performance data were gathered via an internet portal.MethodsLaboratory Day included computer-based cognitive tests on attention, working memory and executive functions. Electroencephalography (EEG), electrocardiography (ECG) and electrodermal activity (EDA) were recorded during the tests. A saccade test with electro-oculography (EOG) and event-related potentials (ERP) to emotionally loaded sounds were also done. First three home recordings included tablet-based cognitive tests, sleep polysomnography (PSG), ECG, and actigraphy; the 4thonly an actigraphy and sleep diary.Outcome measuresExecutability and repeatability of the protocol: Number of patients completing the study, success rate of carrying it out as planned, obtained data and patient feedback.ResultsIn 13 (81%) patients all data from home recordings was obtained as planned. In 11 (68%) patients the whole protocol was carried out as planned and in 3 partly. The time schedules required adjusting. Patients reported no discomfort from using wearable devices. Patients considered answering the internet-based health questionnaires cumbersome: all data was obtained only in 30%.ConclusionsMobile technologies are a tool kit from which to choose a clinically relevant combination to obtain objective data on a patient’s physical, physiologic, and cognitive performance outside hospital.StrengthsThe study consisted of a wide range of medical devices providing objective information on different physiologic functions and cognitive performance of a patient relevant for daily activities.The research examined executability, repeatability and patient compliance of a clinical study protocol and aspects relevant to obtaining clinically useful data.LimitationsParticipants did not have any chronic diseases that could affect especially home recording successThe study setup and protocol were not tested outside the home environment.The ability of patients to set up the different measurements independently and correctly was not tested.