Laura C. M. Kuijper

: This analysis evaluates the feasibility and psychometric properties of daily digital cognitive assessments (DCAs) delivered on smartphones using data from the large, international Identifying Digital Endpoints to Assess FAtigue, Sleep and acTivities of daily living in Neurodegenerative disorders and Immune-mediated inflammatory diseases (IDEA-FAST) study. The data we analyse were collected from patients with neurodegenerative diseases (NDDs) and immune-mediated inflammatory diseases (IMIDs), and healthy controls (a subset who participated in all phases of the study, total N=1005) in their own homes. These data were obtained alongside data from other devices that monitored physiology, kinematics, and sleep quality. Following a baseline visit, participants were remotely monitored via three scheduled daily sessions for 6-7 days in each of 4 active assessment phases (APs). APs were separated by 6-week intervals. Daily schedules comprised a morning psychomotor vigilance task (PVT) with eDiary, afternoon session (eDiary only), and an evening digit symbol substitution task (DSST) with eDiary. We evaluated session coverage using logistic mixed effects, test-retest reliability using ICCs, disease impacts on performance using linear mixed effect ANCOVA, and familiarisation using linear mixed effects. Overall coverage was 66.7% for the PVT and 76.2% for the DSST, with no significant differences between the healthy volunteers and disease cohorts. Coverage varied significantly by time-of-day (Evening > Morning > Afternoon), and improved with age, with an interaction revealing session time-of-day affected older participants less, all p < .001. Coverage was highest in AP 1 and reduced in subsequent APs. AP-day effects on coverage interacted significantly with AP, with a modest decline over AP 1, and the pattern reversed in APs 2-4. Baseline reliability was good (> .70) for both PVT mean reaction time and DSST total correct across all cohorts, and the movement-based measure from the DSST ranged [.54, .82], with lower values in the Parkinson’s Disease and Primary Sjögren’s Syndrome cohorts. Both tasks showed significant cohort effects, with performance in IMID cohorts intermediate between healthy controls and NDD. Longitudinal analysis revealed significant familiarisation effects in DSST. This was greatest in healthy controls, with significant attenuation of these effects in disease cohorts. No effect of familiarisation was seen in the PVT. Collectively, these results support the usefulness of at-home cognitive assessment on smartphones. Brief measures of cognition can be captured remotely in disease as well as controls with good adherence and sensitivity to distinguish known patient groups from healthy controls.

Background: Fatigue, impaired sleep quality and daytime sleepiness, common in neurodegenerative and immune-mediated diseases, are debilitating and have serious societal and economic implications. Currently, measurement of these symptoms largely relies on self-reported questionnaires, which are burdensome for patients and lack sensitivity, granularity and reliability. Methods: Building on a preceding feasibility study and qualification advice of the European Medicines Agency, the Clinical Observational Study of the European project Identifying Digital Endpoints to Assess FAtigue, Sleep and acTivities of daily living in Neurodegenerative disorders and Immune-mediated inflammatory diseases (IDEA-FAST) investigates the relationship between digital and clinical parameters of the target concepts of fatigue, reduced sleep quality and daytime sleepiness. Results: Between 2022 and 2025, 2000 people are being recruited at 24 European sites – 500 with Parkinson's disease, 500 with inflammatory bowel disease, 200 with each of the following diseases: Huntington's disease, rheumatoid arthritis, systemic lupus erythematosus, primary Sjögren's syndrome and 200 healthy volunteers. Participants are followed over a 24-week period with four visits, each including a 1-week assessment phase at home using CE-certified digital health (including active and passive) technologies. The latter collect information on physical activity, physiology, cognition as well as social interaction and behaviour as core dimensions of the target concepts. Conclusion: This study will help to develop reliable, valid and efficient digital endpoints of fatigue, impaired sleep quality and daytime sleepiness for use in future clinical studies and trials.

Objectives: Huntington's disease (HD) is a hereditary neurodegenerative disorder characterized by a range of motor, cognitive, and psychiatric symptoms. Psychological symptoms can arise from being at risk for the disease and from its manifestation, necessitating psychological interventions to address the evolving burden, even before onset. This qualitative study explores the psychological interventions used for HD within the Dutch health care context and identifies barriers and facilitators for their implementation across the different HD disease stages. Methods: A qualitative approach using semi‐structured interviews was employed, involving 13 experienced psychologists from HD health care facilities in the Netherlands. Thematic analysis was conducted to explore the types of psychological interventions used and the facilitators and barriers affecting their implementation. Results: The study identified a range of generic and more specific interventions, with their application varying according to the stages of HD. Early interventions focus on genetic counselling and trauma therapy, while mid to late‐stage care incorporates acceptance and commitment therapy (ACT) and cognitive behavioural therapy (CBT) for managing psychological symptoms. Late‐stage interventions shift to mediated approaches involving family and care teams. Key barriers include cognitive impairments and difficulties in referring patients to other mental health care providers, while key facilitators include multidisciplinary collaboration and preventive interventions. Conclusions: Psychological interventions for HD in the Netherlands are adapted to the disease progression, emphasizing the need for stage‐specific and personalized care. The findings highlight best‐care practices and the importance of early intervention, multidisciplinary collaboration, and evaluation while identifying areas for further research and improvement in care quality.

Background Proper medication reconciliation (= comparing the accuracy of patient-reported medication use with pharmacy records) could prevent potentially dangerous situations such as drug–drug interactions and hospitalization. This is particularly important when patients rely on multiple medications, such as in neurodegenerative disorders like Huntington’s Disease (HD). Currently, it is unknown how often medication discrepancies occur in HD patients and which factors contribute to the discrepancies. Objective Identify prognostic factors of medication discrepancies in HD, using patient-reported medication use and local pharmacy records. Methods With 134 pre- and manifest HD patients, we performed a multivariable logistic regression analysis with medication discrepancy as dependent variable (pharmacy records as reference value) and sex, CAP score, disease status (pre- or manifest HD), number of concomitant medications taken, presence of an informal caregiver, Unified Huntington’s Disease Rating Scale-Total Functioning Capacity, unified cognitive Z-score and Problem Behaviors Assessment-short characteristic scores for depression, anxiety, and apathy as independent variables. Results Medication discrepancies were reported frequently, both in premanifest (43.2%) and manifest HD subjects (36.7%). Impaired cognition significantly predicted medication discrepancies (beta = −0.688, SE 0.27, p = 0.011). All other variables were non-significant. Conclusions Regardless of HD disease status and stage, patient self-reported medication use is not a reliable source, especially in those with impaired cognitive function. The presence of an informal caregiver and the absence of polypharmacy, depression, anxiety and apathy do not influence self-reported medication accuracy. Objective verification of medication use with HD patients’ local pharmacy is recommended. Trial registration number ICTRP-NL-OMON55123, HD-med, registered 26-Nov-2019.