Amyotrophic Lateral Sclerosis, Motor Neuron Disease
Conditions
Keywords
Quality of Life, ALSAQ-40, ALSFRS-R, Physical Functioning, Patient Reported Outcomes, PRO, King's Clinical Severity Staging System, QoL, Amyotrophic Lateral Sclerosis, ALS, Motor Neuron Disease, MND
Brief summary
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.
Detailed description
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).
Interventions
Patient-Reported Functionality Assessment
OTHERAmyotrophic Lateral Sclerosis Assessment Questionnaire-40
Patient-Reported Quality-of-Life Assessment
Sponsors
TidalHealth, Inc.
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Results of the Amyotrophic Lateral Sclerosis Assessment Questionnaire (ALSAQ-40) | Assessment will start at the initial visit, then every other standard-of-care clinic visit, through study completion (assessed up to 2 years). | Participants report a response related to their overall health condition during the past two weeks; all answers are given on a five-point Likert Scale. Where 0 indicates best health status and 4 indicates worst. |
| Results of the Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised (ALSFRS-R) | Assessment will start at the initial visit, then every standard-of-care clinic visit, through study completion (assessed up to 2 years). | Participants report a response related to their functional status; all answers are given on a four-point Likert Scale. Where 0 indicates maximum disability and 4 indicates normal function. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| King's Clinical Severity Staging System | Assessment will start at the initial visit, then every standard-of-care clinic visit, through study completion (assessed up to 2 years). | The King's Clinical Severity Staging System is used to assess the level of disease involvement by body region involvement. Where Stage 1 is defined as one region of the body involved, Stage 2 defined as two regions of involvement, Stage 3 defined as three regions, and Stage 4 is defined as respiratory or nutritional failure. |
Countries
United States
Contacts
CONTACTAllison D Elerding, MS
Outcome results
None listed