scholarly journals Objectively Monitoring Amyotrophic Lateral Sclerosis Patient Symptoms During Clinical Trials With Sensors: Observational Study

10.2196/13433 ◽  
2019 ◽  
Vol 7 (12) ◽  
pp. e13433 ◽  
Author(s):  
Luis Garcia-Gancedo ◽  
Madeline L Kelly ◽  
Arseniy Lavrov ◽  
Jim Parr ◽  
Rob Hart ◽  
...  
Keyword(s):  
Physical Activity ◽  
Clinical Trials ◽  
Amyotrophic Lateral Sclerosis ◽  
Home Monitoring ◽  
Home Setting ◽  
Time Points ◽  
Speech Data ◽  
The Impact ◽  
Lateral Sclerosis

Background Objective symptom monitoring of patients with Amyotrophic Lateral Sclerosis (ALS) has the potential to provide an important source of information to evaluate the impact of the disease on aspects of real-world functional capacity and activities of daily living in the home setting, providing useful objective outcome measures for clinical trials. Objective This study aimed to investigate the feasibility of a novel digital platform for remote data collection of multiple symptoms—physical activity, heart rate variability (HRV), and digital speech characteristics—in 25 patients with ALS in an observational clinical trial setting to explore the impact of the devices on patients’ everyday life and to record tolerability related to the devices and study procedures over 48 weeks. Methods In this exploratory, noncontrolled, nondrug study, patients attended a clinical site visit every 3 months to perform activity reference tasks while wearing a sensor, to conduct digital speech tests and for conventional ALS monitoring. In addition, patients wore the sensor in their daily life for approximately 3 days every month for the duration of the study. Results The amount and quality of digital speech data captured at the clinical sites were as intended, and there were no significant issues. All the home monitoring sensor data available were propagated through the system and were received as expected. However, the amount and quality of physical activity home monitoring data were lower than anticipated. A total of 3 or more days (or partial days) of data were recorded for 65% of protocol time points, with no data collected for 24% of time points. At baseline, 24 of 25 patients provided data, reduced to 13 of 18 patients at Week 48. Lower-than-expected quality HRV data were obtained, likely because of poor contact between the sensor and the skin. In total, 6 of 25 patients had mild or moderate adverse events (AEs) in the skin and subcutaneous tissue disorders category because of skin irritation caused by the electrode patch. There were no reports of serious AEs or deaths. Most patients found the sensor comfortable, with no or minimal impact on daily activities. Conclusions The platform can measure physical activity in patients with ALS in their home environment; patients used the equipment successfully, and it was generally well tolerated. The quantity of home monitoring physical activity data was lower than expected, although it was sufficient to allow investigation of novel physical activity end points. Good-quality in-clinic speech data were successfully captured for analysis. Future studies using objective patient monitoring approaches, combined with the most current technological advances, may be useful to elucidate novel digital biomarkers of disease progression.

scholarly journals Objectively Monitoring Amyotrophic Lateral Sclerosis Patient Symptoms During Clinical Trials With Sensors: Observational Study (Preprint)

2019 ◽  
Author(s):  
Luis Garcia-Gancedo ◽  
Madeline L Kelly ◽  
Arseniy Lavrov ◽  
Jim Parr ◽  
Rob Hart ◽  
...  
Keyword(s):  
Physical Activity ◽  
Clinical Trials ◽  
Amyotrophic Lateral Sclerosis ◽  
Home Monitoring ◽  
Home Setting ◽  
Time Points ◽  
Speech Data ◽  
The Impact ◽  
Lateral Sclerosis

BACKGROUND Objective symptom monitoring of patients with Amyotrophic Lateral Sclerosis (ALS) has the potential to provide an important source of information to evaluate the impact of the disease on aspects of real-world functional capacity and activities of daily living in the home setting, providing useful objective outcome measures for clinical trials. OBJECTIVE This study aimed to investigate the feasibility of a novel digital platform for remote data collection of multiple symptoms—physical activity, heart rate variability (HRV), and digital speech characteristics—in 25 patients with ALS in an observational clinical trial setting to explore the impact of the devices on patients’ everyday life and to record tolerability related to the devices and study procedures over 48 weeks. METHODS In this exploratory, noncontrolled, nondrug study, patients attended a clinical site visit every 3 months to perform activity reference tasks while wearing a sensor, to conduct digital speech tests and for conventional ALS monitoring. In addition, patients wore the sensor in their daily life for approximately 3 days every month for the duration of the study. RESULTS The amount and quality of digital speech data captured at the clinical sites were as intended, and there were no significant issues. All the home monitoring sensor data available were propagated through the system and were received as expected. However, the amount and quality of physical activity home monitoring data were lower than anticipated. A total of 3 or more days (or partial days) of data were recorded for 65% of protocol time points, with no data collected for 24% of time points. At baseline, 24 of 25 patients provided data, reduced to 13 of 18 patients at Week 48. Lower-than-expected quality HRV data were obtained, likely because of poor contact between the sensor and the skin. In total, 6 of 25 patients had mild or moderate adverse events (AEs) in the skin and subcutaneous tissue disorders category because of skin irritation caused by the electrode patch. There were no reports of serious AEs or deaths. Most patients found the sensor comfortable, with no or minimal impact on daily activities. CONCLUSIONS The platform can measure physical activity in patients with ALS in their home environment; patients used the equipment successfully, and it was generally well tolerated. The quantity of home monitoring physical activity data was lower than expected, although it was sufficient to allow investigation of novel physical activity end points. Good-quality in-clinic speech data were successfully captured for analysis. Future studies using objective patient monitoring approaches, combined with the most current technological advances, may be useful to elucidate novel digital biomarkers of disease progression.

Amyotrophic Lateral Sclerosis

2018 ◽  
Keyword(s):  
Quality Of Life ◽  
Amyotrophic Lateral Sclerosis ◽  
Health Care Professionals ◽  
New Technologies ◽  
Neurodegenerative Disorder ◽  
Well Being ◽  
Psychological Well Being ◽  
The Impact ◽  
Lateral Sclerosis

Amyotrophic lateral sclerosis: Understanding and optimizing quality of life and psychological well-being presents a comprehensive and up-to-date review of the enhancement of the lives of people with amyotrophic lateral sclerosis (ALS) and their caregivers. ALS is a progressive, fatal neurodegenerative disorder. No current medical therapy can reverse or stop its progression, and the promotion of quality of life and psychological well-being is a central component of ALS care. Health care professionals who work in this field should incorporate attention to psychological, emotional, and relational aspects of the disease into their approach to care. This book provides some of the knowledge and direction necessary for optimizing the quality of care for individuals with ALS and their caregivers. Topics discussed include an ALS-centred view of quality of life, depressive features, anxiety, resilience, cognitive impairment, complementary and alternative medicines, and psychological research. Specific elements of ALS, such as end-of-life concerns and bulbar dysfunction, are described through the lens of their psychological impact. There is extensive discussion of the development of new psychological treatments, as well as the impact and incorporation of new technologies, with the goal of fostering optimal quality of life and psychological well-being as key parts of a holistic approach to care for the patients and for those who are close to such individuals.

Mindfulness and mindlessness and ALS

2018 ◽  
Author(s):  
Francesco Pagnini ◽  
Deborah Phillips ◽  
Eleonora Volpato ◽  
Paolo Banfi ◽  
Ellen Langer
Keyword(s):  
Quality Of Life ◽  
Amyotrophic Lateral Sclerosis ◽  
Well Being ◽  
Psychological Resilience ◽  
Psychological Well Being ◽  
Psychological Constructs ◽  
The Impact ◽  
Lateral Sclerosis

Mindfulness and mindlessness are two relevant psychological constructs for the field of amyotrophic lateral sclerosis (ALS). When mindful, people are more open, flexible, and aware, and this attitude results in a higher psychological well-being. A mindful attitude is a source of psychological resilience for people with ALS and their caregivers. Conversely, a mindless view about the illness, reducing the whole person’s identify to the diagnosis, represents a threat to their quality of life. Furthermore, preliminary findings seem to suggest that mindfulness is associated with a slower course of the disease. In this chapter we discuss the impact that mindfulness can exert on both the quality and the quantity of life.

scholarly journals Quality of life among relatives of patients with amyotrophic lateral sclerosis: A prospective and longitudinal study

2021 ◽  
pp. 1-9
Author(s):  
Birgitta Jakobsson Larsson ◽  
Anneli Ozanne ◽  
Karin Nordin ◽  
Ingela Nygren
Keyword(s):  
Quality Of Life ◽  
Amyotrophic Lateral Sclerosis ◽  
Physical Function ◽  
Well Being ◽  
Individual Quality ◽  
Time Points ◽  
Disease Trajectory ◽  
Individual Quality Of Life ◽  
Lateral Sclerosis

Abstract Objective Relatives are often central in caring for patients with amyotrophic lateral sclerosis (ALS), involving considerable physical, emotional, and social challenges. The aim of this study was to describe individual quality of life (iQoL) among relatives of patients with ALS, from diagnosis through disease progression. Method A total of 31 relatives were included. Data collection was performed at five time points: 1–3 months after their relatives had been diagnosed with ALS and every 6 months for 2 years. Quality of life was determined using the Schedule of Evaluation of Individual Quality of Life — Direct Weighting (SEIQoL-DW), emotional distress with the Hospital Anxiety and Depression Scale (HADS), and the illness severity of the patients was determined with the Amyotrophic Lateral Sclerosis Functional Rating Scale (ALS FRS-R). Results The SEIQoL-DW involves participants nominating the important life areas. The most nominated areas were family, friends, health, and leisure. Although most relatives had overall good and stable iQoL, several had scores indicating poor iQoL on some occasions during the disease trajectory. The relatives’ iQoL correlated with emotional well-being and the patient's physical function at different time points. Significant of result Social relations, emotional well-being, and rapid decline in the patient's physical function influence the relatives’ iQoL. Measuring both emotional well-being and iQoL, with a focus on the relatives’ own descriptions of perceived iQoL and those factors contributing to their iQoL during the disease trajectory may improve the possibility of identifying and supporting those relatives with poor iQoL.

Measurement of Health-Related Quality of Life in Patients With Amyotrophic Lateral Sclerosis in Clinical Trials of New Therapies

Medical Care ◽  
1999 ◽  
Vol 37 (1) ◽  
pp. 15-26 ◽  
Author(s):  
Anne M. Damiano ◽  
Donald L. Patrick ◽  
Gladys I. Guzman ◽  
Marek J. Gawel ◽  
Deborah F. Gelinas ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Clinical Trials ◽  
Amyotrophic Lateral Sclerosis ◽  
Health Related Quality ◽  
New Therapies ◽  
Related Quality ◽  
Health Related ◽  
Lateral Sclerosis

scholarly journals Dysarthria and quality of life in patients with amyotrophic lateral sclerosis

Revista CEFAC ◽  
2017 ◽  
Vol 19 (5) ◽  
pp. 664-673 ◽  
Author(s):  
Lavoisier Leite Neto ◽  
Ana Carolina Constantini
Keyword(s):  
Quality Of Life ◽  
Amyotrophic Lateral Sclerosis ◽  
Background Information ◽  
Control Group ◽  
Life Questionnaire ◽  
Significance Level ◽  
Assessment Protocol ◽  
The Impact ◽  
Lateral Sclerosis

ABSTRACT Purpose: to analyze the impact of dysarthria on the quality of life in patients with amyotrophic lateral sclerosis. Methods: the study consisted of 32 subjects, divided into two groups (control group and study group) who underwent an initial interview for background information, followed by an evaluation based on the Dysarthria Assessment Protocol and completion of quality of life questionnaire "Living with Dysarthria - (LwD)". Exploratory data analysis was collected through mean, median, SD, minimum and maximum measures. A comparison was performed between the studied groups and a correlation was carried out between scores. The significance level adopted was 5%. Results: according to the findings, all sub-items analyzed by the dysarthria assessment protocol were statically significant (p <0.001) when comparing the groups. Regarding quality of life, a moderate positive correlation (p = 0.0008; Spearman's coefficient = 0.75202) was observed between the total score of the two protocols used, indicating that the higher the degree of dysarthria, the worse the Quality of Life (QOL) of the subject, according to the parameters evaluated. Conclusion: dysarthria affects all speech parameters herein assessed, in varying degrees, negatively impacting communication and quality of life.

scholarly journals Exploring and Addressing ‘Concerns’ for Significant Others to Extend the Understanding of Quality of Life With Amyotrophic Lateral Sclerosis: A Qualitative Study

2019 ◽  
Vol 11 ◽  
pp. 117957351985936 ◽  
Author(s):  
Hikari Ando ◽  
Rosanna Cousins ◽  
Carolyn A Young
Keyword(s):  
Quality Of Life ◽  
Amyotrophic Lateral Sclerosis ◽  
Sense Of Self ◽  
Holistic Approach ◽  
Significant Others ◽  
World Health ◽  
The Impact ◽  
Depth Interviews ◽  
Lateral Sclerosis

Background: The absence of curative medication for amyotrophic lateral sclerosis (ALS) makes palliative care and understanding quality of life (QoL) in ALS a clinical priority. Previous qualitative research has explored the concept of QoL in terms of illness impact on life perspectives and sense of self. Objective: In this research, we explored ‘concerns’ – one of the four aspects in the World Health Organisation’s conceptualisation of QoL – towards adding to the literature. Methods: In-depth interviews with 26 individuals with ALS were subjected to thematic analysis involving both inductive and deductive approaches to explore participant’s concerns, and to evaluate the relevance of their concerns for understanding QoL in ALS. Findings: The analysis showed that concerns for significant others contribute to participant’s QoL because of their existential value. It was important for participants to minimise the impact of limitations and burdens associated with ALS on significant others, even at a cost to self. Discussion: The current study supports a holistic approach in service provision, ensuring the inclusion of relevant significant others. It is further suggested that clinicians explore the specifics of burdens perceived by patients in order to support them in minimising the burdens for their significant others.

scholarly journals A systematic review of neuropsychiatric and cognitive assessments used in clinical trials for amyotrophic lateral sclerosis

2020 ◽  
Author(s):  
Emily Beswick ◽  
Emily Park ◽  
Charis Wong ◽  
Arpan R. Mehta ◽  
Rachel Dakin ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Amyotrophic Lateral Sclerosis ◽  
Cognitive Impairment ◽  
Outcome Measures ◽  
Neuropsychiatric Symptoms ◽  
Secondary Outcome ◽  
Secondary Outcome Measure ◽  
Exclusion Criteria ◽  
The Impact ◽  
Lateral Sclerosis

Abstract Background Up to 50% of people with amyotrophic lateral sclerosis (ALS) experience cognitive dysfunction, whilst depression and anxiety are reported in up to 44% and 33%, respectively. These symptoms impact on quality of life, and are associated with a poorer prognosis. Historically, outcomes in clinical trials have focused on the effect of candidate drugs on physical functioning. Methods We reviewed the past 25 years of clinical trials of investigative medicinal products in people with ALS, since the licensing of riluzole, and extracted data on frequency and type of assessment for neuropsychiatric symptoms and cognitive impairment. Trial registry databases, including WHO International Trials Registry, European Clinical Trials Register, clinicaltrials.gov, and PubMed, were systematically searched for Phase II, III or IV trials registered, completed or published between 01/01/1994 and 31/10/2019. No language restrictions were applied. Outcome measures, exclusion criteria and assessment tool used were extracted. Results 216 trials, investigating 26,326 people with ALS, were reviewed. 35% assessed neuropsychiatric symptoms, and 22% assessed cognition, as Exclusion Criteria or Outcome Measures. 3% (n = 6) of trials assessed neuropsychiatric symptoms as a Secondary Outcome Measure, and 4% (n = 8) assessed cognition as Outcome Measures; only one trial included assessments for both cognition and neuropsychiatric symptoms as Outcome Measures. Three ALS-specific assessments were used in six trials. Conclusions Trials for people with ALS have neglected the importance of neuropsychiatric symptoms and cognitive impairment. Evaluation of these extra-motor features is essential to understanding the impact of candidate drugs on all symptoms of ALS. PROPSERO registration CRD42020175612.

scholarly journals Neuropsychological deficits have only limited impact on psychological well-being in amyotrophic lateral sclerosis

2021 ◽  
Author(s):  
Till Schrempf ◽  
Julia Finsel ◽  
Ingo Uttner ◽  
Albert C. Ludolph ◽  
Dorothée Lulé
Keyword(s):  
Quality Of Life ◽  
Amyotrophic Lateral Sclerosis ◽  
Well Being ◽  
Neuropsychological Deficits ◽  
Neurocognitive Deficits ◽  
Psychological Well Being ◽  
Global Quality Of Life ◽  
The Impact ◽  
Lateral Sclerosis

Abstract Objective To investigate the association between neuropsychological deficits and psychological well-being in amyotrophic lateral sclerosis (ALS). Methods Subjective (Schedule for the Evaluation of the Individual Quality of Life-Direct Weighting, SEIQoL-DW) and global quality of life (QoL; Anamnestic Comparative Self-Assessment, ACSA) as well as depression (ALS-Depression-Inventory, ADI-12) as indicators for psychological well-being were measured in 214 patients with ALS and correlated with neurocognitive performance assessed by the Edinburgh Cognitive and Behavioural ALS Screen (ECAS). Primary caregivers evaluated behaviour. Patients were classified to be cognitively (ALSci) or behaviourally impaired (ALSbi) according to Strong criteria. Results ALSbi patients had poorer psychological well-being than patients without behavioural alterations, while the psychological well-being of patients with and without neurocognitive deficits was comparable. Conclusion The study provides evidence that minor neuropsychological deficits do not interfere with psychological well-being of ALS in contrast to alterations on behavioural level. Thus, abnormalities in individual cognitive domains have limited relevance for the patients’ everyday life in comparison to the impact of behavioural alterations.

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