Impact of Physical Functioning on Patient-Reported Outcomes in ALS Patients at TidalHealth

The Impact of Physical Functioning on Self-Reported Measures of Quality of Life in the ALS Patient Population at TidalHealth Peninsula Regional

Amyotrophic Lateral Sclerosis (ALS) is a fatal neurodegenerative disease in which motor neuron cells of the brain and spinal cord progressively degenerate and die. There is currently a lack of curative treatment for individuals that are diagnosed with ALS. Since treatment options are limited, researchers have placed greater emphasis on evaluating Quality-of-Life (QoL) as it offers perspective into the everyday life of the patient and is sensitive to changes over time.

The goal of this longitudinal observational study is to learn more about what factors negatively impact an individual's QoL after they are diagnosed with ALS. Previous research has shown that an individual's level of physical functioning can negatively impact their quality of life, but this may not be the only factor.

The main objectives this study are:

1. Assess if there is a statistically significant correlation between patient's functionality scores (ALSFRS-R) and quality of life scores (ALSAQ-40).
2. Determine how disease stage (King's Clinical Severity Staging System) affects correlation between functionality scores (ALSFRS-R) and quality of life scores (ALSAQ-40).

Participants will complete a quality-of-life questionnaire (ALSAQ-40) every other time they present to their standard-of-care clinic visits for a period of two years. In parallel, with the functionality rating (ALSFRS-R) scores captured as standard-of-care at every clinic visit.

This prospective longitudinal study aims to examine factors that contribute to negative health-related Quality of life (QoL) in the Amyotrophic Lateral Sclerosis (ALS) Patient Population at TidalHealth Peninsula Regional. Previous research has focused on how declining physical functioning is shown to negatively impact QoL, but this may not be the only factor. Newer research has shown that cognitive and behavioral changes associated with ALS may additionally negatively impact a patient's QoL. This highlights an important knowledge gap regarding the complex set of factors that affect patient's quality of life when living with ALS. This patient reported outcome study will attempt to provide data supporting clinical decisions that will aim to improve the quality of life of patient in this population. Patient reported quality of life will be measured through the Amyotrophic Lateral Sclerosis Assessment Questionnaire (ALSAQ-40) and level of physical functioning will be measured through the Amyotrophic Lateral Sclerosis Functional Rating Scale (ALSFRS-R).

Inclusion Criteria:

• Over the age of 18
• Have a diagnosis of Amyotrophic Lateral Sclerosis of Motor Neuron Disease
• Able to comprehend and willing to sign an informed consent form and comply with study procedures.
• Receiving care at TidalHealth Peninsula Regional Multidisciplinary ALS Clinic

Exclusion Criteria:

• Unable to read and understand English
• Unwilling or unable to comply with the study procedure, including the presence of any condition that is likely to affect the participant's ability to comply with study procedures.