Impact of Physical Functioning on Patient-Reported Outcomes in ALS Patients at TidalHealth
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorTidalHealth, Inc.
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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.
Trial population
Amyotrophic Lateral Sclerosis and Motor Neuron Disease patients over the age of 18 receiving care at TidalHealth's Peninsula Regional multidisciplinary ALS Clinic.
Trial design
Design model
Other
Time perspective
Prospective
Treatments tested in this trial
Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised
Other interventionPatient-Reported Functionality Assessment
Amyotrophic Lateral Sclerosis Assessment Questionnaire-40
Other interventionPatient-Reported Quality-of-Life Assessment
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
Results of the Amyotrophic Lateral Sclerosis Assessment Questionnaire (ALSAQ-40)
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.
Time frame
Assessment will start at the initial visit, then every other standard-of-care clinic visit, through study completion (assessed up to 2 years).2
Results of the Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised (ALSFRS-R)
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.
Time frame
Assessment will start at the initial visit, then every standard-of-care clinic visit, through study completion (assessed up to 2 years).Secondary outcomes
1
King's Clinical Severity Staging System
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.
Time frame
Assessment will start at the initial visit, then every standard-of-care clinic visit, through study completion (assessed up to 2 years).Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov