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
Authors: Müller Kiti , Rautalin Ilari , Ahonen Lauri , Arola Anne , Henelius Andreas , Jokinen Hanna , Korpela Jussi , Korja Miikka , Martinez-Majander Nicolas , Mustonen Aaro , Paajanen Teemu , Pakarinen Satu , Pettersson Kati , Putaala Jukka , Sokka Laura , Tikka Tuomas , Virkkala Jussi 
Published: February 2023

Objectives

Reasons 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.

Participants

Sixteen patients undergoing neurosurgery for unruptured intracranial aneurysm (UIA), each acting as one’s own control.

Study Protocol

Two 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.

Methods

Laboratory 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 measures

Executability and repeatability of the protocol: Number of patients completing the study, success rate of carrying it out as planned, obtained data and patient feedback.

Results

In 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%.

Conclusions

Mobile 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.

Strengths

The 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.

Limitations

Participants did not have any chronic diseases that could affect especially home recording success

The 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.