In person versus remote cognitive rehabilitation in patients with subjective cognitive decline or neurocognitive disorders: what factors drive patient's preference?

Background: To date, there is still a lack of consensus for identifying the ideal candidate for cognitive telerehabilitation (TR). The main goal of the present study is to identify the factors associated to the preference for either TR or in-person cognitive training (CT) programs in older adults at risk of dementia or with early cognitive impairment. Methods: A sample of 56 participants with subjective cognitive decline or neurocognitive disorders eligible for CT were enrolled at the Dementia Research Center and Neurorehabilitation Unit of IRCCS Mondino Foundation. All individuals underwent a baseline assessment to capture their complete profile, including cognitive reserve and lifestyle habits, sociodemographic characteristics, cognitive functioning, and mental health. Patients were then asked their preference for TR or in-person CT, before being randomized to either treatment as per protocol procedures. Statistical analyses included explorative descriptive approach, logistic regression, and non-parametric models to explore the overall contribution of each variable. Results: The two (TR and in-person) preference groups were similar for cognitive functioning and mental health status. Socio-demographic and lifestyle profiles seem to be the most important factors to influence the preference in terms of the area under the curve (AUC) of the models. The two preference groups differed in terms of socio-demographic characteristics (e.g., level of technological skills, age, and distance from the clinic). Furthermore, participants who selected the TR modality of CT had significantly higher levels of cognitive reserve and adopted more protective lifestyle habits (e.g., regular physical activity, Mediterranean diet) when compared to those who preferred in-person CT. Discussion: These findings highlight that the preference to receive CT delivered by TR or in person is a complex issue and is influenced by a variety of factors, mostly related to lifestyle habits and sociodemographic characteristics. Availability of profiles of patients that may be more attracted to one or the other modality of TR may help promote shared decision-making to enhance patient experience and outcomes.

HomeCoRe system for telerehabilitation in individuals at risk of dementia: A usability and user experience study.

Background: Telerehabilitation has enabled a broader application of cognitive rehabilitation programs. We have recently developed HomeCoRe, a system for supporting cognitive intervention remotely with the assistance of a family member. The main goal of the present study was to determine usability and user experience of HomeCoRe in individuals at risk of dementia and in their family members. The association between subjects' technological skills and main outcome measures was evaluated as well. Methods: Fourteen individuals with subjective cognitive decline (SCD) or mild neurocognitive disorder (mNCD) were recruited to participate in this pilot study. All participants received a touch-screen laptop implemented with the HomeCoRe software. The intervention consisted of 18 sessions and included a patient-tailored adaptive protocol of cognitive exercises. Usability was assessed in terms of treatment adherence and participants' performance across sessions; user experience via self-reported questionnaires and a descriptive diary. Results: Usability and user experience were overall satisfactory and suggested usability, pleasantness, and high motivation while using HomeCoRe. Technological skills correlated only with the perceived ability to start and/or perform exercises autonomously. Discussion: These results, although preliminary, suggest that the usability and user experience of HomeCoRe are satisfactory and independent of technological skills. These findings encourage wider and more systematic use of HomeCoRe to overcome the current limitations of in-person cognitive rehabilitation programs and to reach more individuals at risk of dementia.

Outcomes of a computer-based cognitive training (CoRe) in early phases of cognitive decline: a data-driven cluster analysis.

The present study aimed to identify clusters of cognitive profiles as well as to explore the effects of these clusters on demographic/individual characteristics and on improvements after a computer-based cognitive training (CCT) in early cognitive impairment. Fifty-seven subjects underwent to an adaptive CCT for 3 weeks (4 individual face-to-face sessions/week of 45 min) and were evaluated at baseline (T0), post-intervention (T1), and after 6 (T2) and 12 (T3) months. Clusters of cognitive profiles were explored with k-means analysis. The analysis revealed two clusters, which were composed by 27 and 30 patients characterized by lower (Cluster 1) and higher (Cluster 2) cognitive functioning. At T1, cognitive performance improved in both groups, but Cluster 1 gained more benefits in global cognitive functioning than Cluster 2. However, at T3, Cluster 2 remained stable in its clinical condition, whereas Cluster 1 showed a pronounced worsening. In conclusion, Cluster 1 profile was associated with a more marked but also short-lasting responsiveness to CCT, whereas patients fitting with Cluster 2 characteristics seemed to obtain more CCT benefits in terms of stability or even delay of cognitive/functional decline. These findings may have relevant implications in informing the timing and modality of delivery of CCT.

A double-blind randomized controlled trial combining cognitive training (CoRe) and neurostimulation (tDCS) in the early stages of cognitive impairment.

BACKGROUND: The prevalence of neurodegenerative diseases is expected to increase over the next years, therefore, new methods able to prevent and delay cognitive decline are needed. AIMS: To evaluate the effectiveness of a combined treatment protocol associating a computerized cognitive training (CoRe) with anodal transcranial direct current stimulation (tDCS). METHODS: In this randomized controlled trial, 33 patients in the early stage of cognitive impairment were assigned to the experimental group (CoRE + real tDCS) or control group (CoRE + sham tDCS). In each group, the intervention lasted 3 consecutive weeks (4 sessions/week). A neuropsychological assessment was administered at baseline (T0), post-intervention (T1) and 6-months later (T2). RESULTS: The CoRE + real tDCS group only improved in working memory and attention/processing speed at both T1 and T2. It reported a stable MMSE score at T2, while the CoRE + sham tDCS group worsened. Age, mood, and T0 MMSE score resulted to play a role in predicting treatment effects. CONCLUSION: Combined multi-domain interventions may contribute to preventing or delaying disease progression. TRIAL REGISTRATION: Trial registration number (ClinicalTrials.gov): NCT04118686.

HomeCoRe for Telerehabilitation in Mild or Major Neurocognitive Disorders: A Study Protocol for a Randomized Controlled Trial.

Background: Given the limited effectiveness of pharmacological treatments for cognitive decline, non-pharmacological interventions have gained increasing attention. Evidence exists on the effectiveness of cognitive rehabilitation in preventing elderly subjects at risk of cognitive decline and in reducing the progression of functional disability in cognitively impaired individuals. In recent years, telerehabilitation has enabled a broader application of cognitive rehabilitation programs. The purpose of this study is to test a computer-based intervention administered according to two different modalities (at the hospital and at home) using the tools CoRe and HomeCoRe, respectively, in participants with Mild or Major Neurocognitive Disorders. Methods: Non-inferiority, single-blind randomized controlled trial where 40 participants with Mild or Major Neurocognitive Disorders will be assigned to the intervention group who will receive cognitive telerehabilitation through HomeCoRe or to the control group who will receive in-person cognitive intervention through CoRe, with the therapist administering the same computer-based exercises. The rehabilitative program will last 6 weeks, with 3 sessions/week, each lasting ~45 min. All the participants will be evaluated on an exhaustive neuropsychological battery before (T0) and after (T1) the intervention; follow-up visits will be scheduled after 6 (T2) and 12 months (T3). Discussion: The results of this study will inform about the comparability (non-inferiority trial) of HomeCoRe with CoRe. Their equivalence would support the use of HomeCoRe for at distance treatment, favoring the continuity of care. Ethics and Dissemination: This study has been approved by the Local Ethics Committee and registered in https://clinicaltrials.gov (NCT04889560). The dissemination plan includes the scientific community through publication in open-access peer-reviewed scientific journals and presentations at national and international conferences. Trial Registration: Clinicaltrials.gov https://clinicaltrials.gov/ct2/show/NCT04889560 (registration date: May 17, 2021).

A double-blind randomized controlled trial of the efficacy of cognitive training delivered using two different methods in mild cognitive impairment in Parkinson's disease: preliminary report of benefits associated with the use of a computerized tool.

BACKGROUND: The effectiveness of computer-based cognitive training (CCT) remains controversial, especially in older adults with neurodegenerative diseases. AIMS: To evaluate the efficacy of CCT in patients with Parkinson's disease and mild cognitive impairment (PD-MCI). METHODS: In this randomized controlled trial, 53 patients were randomized to receive CCT delivered by means of CoRe software, traditional paper-and-pencil cognitive training (PCT), or an unstructured activity intervention (CG). In each group, the intervention lasted 3 consecutive weeks (4 individual face-to-face sessions/week). Neuropsychological assessment was administered at baseline (T0) and post-intervention (T1). Outcome measures at T0 and T1 were compared within and between groups. The Montreal Overall Cognitive Assessment (MoCA) was taken as the primary outcome measure. RESULTS: Unlike the PCT group and the CG, the patients receiving CCT showed significant medium/large effect size improvements in MoCA performance, global cognition, executive functions, and attention/processing speed. No baseline individual/demographic variables were associated with greater gains from the intervention, although a negative correlation with baseline MoCA performance was found. CONCLUSION: CCT proved effective in PD-MCI patients when compared with traditional PCT. Further follow-up assessments are being conducted to verify the retention of the gains and the potential ability of the tool to delay conversion to PD-dementia. Trial registration number (ClinicalTrials.gov): NCT04111640 (30th September 2019).

Cognitive Telerehabilitation for Older Adults With Neurodegenerative Diseases in the COVID-19 Era: A Perspective Study.

The COVID-19 pandemic is a global health problem that is radically transforming public and private healthcare organizations around the world, negatively affecting the rehabilitative treatments of non-COVID pathologies as well. In this situation, it becomes crucial to be able to guarantee the continuity of care also to all those patients with neurodegenerative diseases unable to reach healthcare services. Remote communication technologies are gaining momentum as potentially effective options to support health care interventions-including cognitive rehabilitation-while patients can stay safely at home. In this context, we are implementing HomeCoRe (i.e., Home Cognitive Rehabilitation software) in order to offer an innovative approach and a valid support for home-based cognitive rehabilitation in neurodegenerative diseases, such as mild cognitive impairment and early dementia. HomeCoRe has been developed within a research project between engineers and clinicians in order to obtain a usable and safe cognitive rehabilitation tool. This software has multiple advantages for patients and therapists over traditional approaches, as shown in its use in hospital settings. HomeCoRe could then represent an opportunity for accessing cognitive rehabilitation in all those situations where patients and therapists are not in the same location due to particular restrictions, such as COVID-19 pandemic.

HomeCoRe: Bringing Cognitive Rehabilitation at Home.

CoRe is a system for cognitive rehabilitation that has been successfully used for several years in hospital settings. Leveraging on the positive survey results from the potential final users (patients and their home caregivers), we developed HomeCoRe. This new version of the system will allow discharged patients to continue the rehabilitation treatment at home.

A computer-based cognitive training in Mild Cognitive Impairment in Parkinson's Disease.

BACKGROUND: There is no successful pharmacological treatment for cognitive impairment in Parkinson's Disease, therefore treatments capable of slowing down the progression of cognitive dysfunction are needed. OBJECTIVE: To evaluate the effectiveness of a cognitive training, supported by the CoRe computerized tool, in patients with Parkinson's Disease Mild Cognitive Impairment. METHODS: This is a prospective, open-unblinded, randomized, controlled study. After baseline cognitive assessment (T0), enrolled patients were randomized to receive motor rehabilitation plus cognitive intervention (G1) or motor rehabilitation only (G2). Follow-up assessments were scheduled 4 weeks (T1) and 6 months after (T2). Global cognitive functioning scores (MOCA and MMSE) were considered as primary outcome. Outcome measures at T0, T1 and T2 were compared within- and between-groups. A percentage change score between T0 and next assessments was calculated to identify patients who improved, remain stable or worsened. RESULTS: Differently from G2, G1 showed a medium/large effect size improvement in primary (MoCA) and secondary outcome, both between T0 and T1 and T0 and T2. Moreover, within G1, most patients improved their cognitive state compared to the baseline. CONCLUSIONS: Patients trained with CoRe showed a better evolution of cognitive decline, while untreated patients tended to get worse over time.

Permutation Entropy Applied to Fitbit Data: Long-Term Sleep Analysis on One Healthy Subject.

In this work we exploited an algorithm, already present in the literature, and based on the notion of signal permutation entropy, to analyze a very long time series of sleep data from a single subject. The aim of the work is to explore methods for personalizing alerts related to sleep anomalies, and recommendations for improving sleep quality. As a matter of fact, sleep duration and sleep quality may differently affect daily performance of different people, as well as daily activities may differently affect sleeping during the night. Data have been collected from a Fitbit Alta HR activity tracker worn by the subject for about three years. Results show that personalized inferences may be very different from the generic (population-based) ones, and that correlations found may suggest subject-specific life-style modifications useful to improve sleep quality.

Evaluation of an ontology-based system for computerized cognitive rehabilitation.

OBJECTIVES: This paper describes the results of a randomized clinical trial about the effectiveness of a computerized rehabilitation treatment on a sample of 31 patients affected by Parkinson disease. METHODS: Computerized exercises were administered by the therapists to the intervention group (n = 17) through the CoRe tool, which automatically generates a big variety of exercises leveraging on a stimuli set (words, sounds and images) organized into a dedicated ontology. A battery of standard neuropsychological tests was performed for patients' assessment at baseline, after the treatment (that lasted 1 month), and after 6 months from the treatment stop. The control group underwent a sham intervention. RESULTS: Results show a statistically significant clinical benefit from computerized rehabilitation with respect to sham treatment. For the intervention group, response time and response accuracy were integrated into a weighted score that accounts also for the specific cognitive burden of each exercise. Differently from the control group, the majority of patients in the intervention group showed an improvement in that score, more marked in the first week of treatment, and which lasts for the entire treatment period, which could account both for a quick learning effect and for an improvement of cognitive conditions. Good usability of CoRe, already observed in previous studies, was confirmed by the present trial, where the percentage of protocol completion in the intervention group is very high (all but one patient are above 90%). CONCLUSIONS: The CoRe system showed to be effective to improve some cognitive abilities in patients with Parkinson disease. However, after the end of the training, the benefit is hardly maintained over time. These findings support the implementation of CoRe in the clinical routine and the continuation of the treatment after discharge through the use of a homecare version of the system.

Computerized Cognitive Rehabilitation: Comparing Different Human-Computer Interactions.

In this work we describe an experiment involving aphasic patients, where the same speech rehabilitation exercise was administered in three different modalities, two of which are computer-based. In particular, one modality exploits the "Makey Makey", an electronic board which allows interacting with the computer using physical objects.

From decision to shared-decision: Introducing patients' preferences into clinical decision analysis.

OBJECTIVE: Taking into account patients' preferences has become an essential requirement in health decision-making. Even in evidence-based settings where directions are summarized into clinical practice guidelines, there might exist situations where it is important for the care provider to involve the patient in the decision. In this paper we propose a unified framework to promote the shift from a traditional, physician-centered, clinical decision process to a more personalized, patient-oriented shared decision-making (SDM) environment. METHODS: We present the theoretical, technological and architectural aspects of a framework that encapsulates decision models and instruments to elicit patients' preferences into a single tool, thus enabling physicians to exploit evidence-based medicine and shared decision-making in the same encounter. RESULTS: We show the implementation of the framework in a specific case study related to the prevention and management of the risk of thromboembolism in atrial fibrillation. We describe the underlying decision model and how this can be personalized according to patients' preferences. The application of the framework is tested through a pilot clinical evaluation study carried out on 20 patients at the Rehabilitation Cardiology Unit at the IRCCS Fondazione Salvatore Maugeri hospital (Pavia, Italy). The results point out the importance of running personalized decision models, which can substantially differ from models quantified with population coefficients. CONCLUSIONS: This study shows that the tool is potentially able to overcome some of the main barriers perceived by physicians in the adoption of SDM. In parallel, the development of the framework increases the involvement of patients in the process of care focusing on the centrality of individual patients.

Patient-tailored workflow patterns from clinical practice guidelines recommendations.

MobiGuide is a project devoted to the development of a patient-centric decision support system based on computerized clinical guidelines for chronic illnesses including Atrial Fibrillation (AF). In this paper we describe the process of (1) identifying guideline recommendations that will require patients to take actions (e.g., take measurement, take drug), thus impacting patients' daily-life behavior, (2) eliciting from the medical experts the corresponding set of personalized operationalized advices that are not explicitly written in the guideline (patient-tailored workflow patterns) and (3) delivering this advice to patients. The analysis of the AF guideline has resulted in four types of patient-tailored workflow patterns: therapy-related advisors, measurements advisors, suggestions for dealing with interventions that may require modulating patient therapy, and personalized packages for close monitoring of patients. We will show how these patterns can be generated using information stored in a patient health record that embeds clinical data and data about the patient's personal context and preferences.

Ontology-based automatic generation of computerized cognitive exercises.

Computer-based approaches can add great value to the traditional paper-based approaches for cognitive rehabilitation. The management of a big amount of stimuli and the use of multimedia features permits to improve the patient's involvement and to reuse and recombine them to create new exercises, whose difficulty level should be adapted to the patient's performance. This work proposes an ontological organization of the stimuli, to support the automatic generation of new exercises, tailored on the patient's preferences and skills, and its integration into a commercial cognitive rehabilitation tool. The possibilities offered by this approach are presented with the help of real examples.

Data mining techniques for analyzing stroke care processes.

Controlled randomized clinical trials and meta-analyses show that stroke patients benefit from access to specialized Stroke Units, in terms of mortality, disability and dependency. However, many issues relating to stroke diagnosis and therapy and to the organization of stroke care remain to be solved and little is known about what interventions make Stroke Units more effective. It is also agreed that compliance with clinical practice guidelines improves health outcomes for these patients, but little is known about the relative weight of the different guideline recommendations. Over the last decade, many hospital- or population-based stroke registers have been set up with the aim of identifying specific key indicators able to monitor the quality and adequacy of acute stroke care. Registers seem to be adequate tools for collecting the data needed to analyze care processes, providing data useful for both national healthcare planning and scientific research. In this paper we applied data mining techniques to data collected within the stroke register of the Lombardia region in Italy. From our analyses both expected and unexpected results have been found: not always compliance to recommendations is related to a good patients' outcome.

Process mining techniques: an application to stroke care.

In a competitive health-care market, hospitals have to focus on ways to streamline their processes in order to deliver high quality care while at the same time reducing costs. To accomplish this goal, hospital managers need a thorough understanding of the actual processes. Diffusion of Information and Communication Technology tools within hospitals, such as electronic clinical charts, computerized guidelines and, more generally, decision support systems, make huge collections of data available, not only for data analysis, but also for process analysis. Process mining can be used to extract process related information (e.g., process models) from data, i.e., process mining describes a family of a-posteriori analysis techniques exploiting the information recorded in the event logs. This process information can be used to understand and redesign processes to become efficient high quality processes. In this paper, we apply process mining on two datasets for stroke patients and present the most interesting results. Above all, the paper demonstrates the applicability of process mining in the health-care domain.

Improving compliance to guidelines through workflow technology: implementation and results in a stroke unit.

This work describes the results of the implementation of a workflow management system integrated into the electronic clinical chart of a Stroke Unit. The workflow logic is based on the rules provided by the SPREAD guidelines for stroke management. In this way, the already existing clinical chart has been transformed into an evidence-based, real-time decision support system, meanwhile maintaining the same look the users were familiar with. Since the final aim of the work was to improve evidence-based behavior and detect possible organizational bottlenecks, non-compliance to the clinical practice guidelines, before and after the system introduction, have been analyzed, as well as the accuracy of the clinical chart compilation, some care process variables, and system usability. Results show that the system enhances the clinical practice without boring users. Moreover, non-compliance analysis gives rise to ideas for further improvement.

Interacting agents through a web-based health serviceflow management system.

The management of chronic and out-patients is a complex process which requires the cooperation of different agents belonging to several organizational units. Patients have to move to different locations to access the necessary services and to communicate their health status data. From their point of view there should be only one organization (Virtual Health-Care Organization) which provides both virtual and face-to-face encounters. In this paper we propose the Serviceflow Management System as a solution to handle these information and the communication requirements. The system consists of: (a) the model of the care process represented as a Serviceflow and developed using the Workflow Management System YAWL; (b) an organizational ontology representing the VHCO; and (c) agreements and commitments between the parties defined in a contract (represented as an XML document). On the basis of a general architecture we present an implementation in the area of Diabetes management.

Workflow technology to enrich a computerized clinical chart with decision support facilities.

Literature results and personal experience show that intrusive modalities of presenting suggestions of computerized clinical practice guidelines are detrimental to the routine use of an information system. This paper describes a solution for smoothly integrating a guideline-based decision support system into an existing computerized clinical chart for patients admitted to a Stroke Unit. Since many years, the healthcare personnel were using a commercial product for the ordinary patients' data management, and they were satisfied with it. Thus, the decision support system has been integrated keeping attention to minimize changes and preserve existing human-computer interaction. Our decision support system is based on workflow technology. The paper illustrates the middleware layer developed to allow communication between the workflow management system and the clinical chart. At the same time, the consequent modification of the graphical users' interface is illustrated.