Amyotrophic Lateral SclerosisALS QoLNCT07491484
Impact of Physical Functioning on Patient-Reported Outcomes in ALS Patients at TidalHealth
An observational study of Amyotrophic Lateral Sclerosis and Motor Neuron Disease, run by TidalHealth, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Amyotrophic Lateral Sclerosis, Motor Neuron Disease
- What is being tested?
- Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised and Amyotrophic Lateral Sclerosis Assessment Questionnaire-40
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Jul 2025to Jul 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Amyotrophic Lateral Sclerosis and Motor Neuron Disease patients over the age of 18 receiving care at TidalHealth's Peninsula Regional multidisciplinary ALS Clinic.
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
TidalHealth Peninsula Regional, Inc.
Salisbury, Maryland, 21801
Allison D Elerding, MS, 410-912-6122, Allison.Elerding@tidalhealth.org
About this study
Official title: 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.
Read more
The main objectives this study are:
- Assess if there is a statistically significant correlation between patient's functionality scores (ALSFRS-R) and quality of life scores (ALSAQ-40).
- 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.
Read the 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).
- Being tested
- Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised, Amyotrophic Lateral Sclerosis Assessment Questionnaire-40
- 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
- Medical subject headings
- Amyotrophic Lateral Sclerosis, Motor Neuron Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amyotrophic Lateral Sclerosis Functional Rating Scale-RevisedOther
Patient-Reported Functionality Assessment
Amyotrophic Lateral Sclerosis Assessment Questionnaire-40Other
Patient-Reported Quality-of-Life Assessment
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Assessment will start at the initial visit, then every other standard-of-care clinic visit, through study completion (assessed up to 2 years).
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.
Measured: 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.
Measured: Assessment will start at the initial visit, then every standard-of-care clinic visit, through study completion (assessed up to 2 years).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2026
- Study start3 Jul 2025
- Primary completionDec 2026 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Amyotrophic Lateral SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- TidalHealth, Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Allison Elerding, TidalHealth, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07491484
- Sponsor's protocol ID
- P25-007
- Acronym
- ALS QoL
- Status last verified
- Mar 2026
- First submitted
- 10 Mar 2026
- Last updated
- 24 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Physical Functioning on Self-Reported Measures of Quality of Life in the ALS Patient Population at TidalHealth Peninsula Regional
- ClinicalTrials.gov ID
- NCT07491484
- Acronym / sponsor ID
- ALS QoL / P25-007
- Keywords
- Quality of Life, ALSAQ-40, ALSFRS-R, Physical Functioning, Patient Reported Outcomes, PRO, King's Clinical Severity Staging System, QoL
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- TidalHealth, Inc.University, hospital or other
- Study start
- 3 Jul 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 24 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Assess if there is a statistically significant correlation between patient's functionality scores (ALSFRS-R) and quality of life scores (ALSAQ-40).
- 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).
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Amyotrophic Lateral Sclerosis and Motor Neuron Disease patients over the age of 18 receiving care at TidalHealth's Peninsula Regional multidisciplinary ALS Clinic.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Amyotrophic Lateral Sclerosis Functional Rating Scale-RevisedPatient-Reported Functionality Assessment | Other | – |
| Amyotrophic Lateral Sclerosis Assessment Questionnaire-40Patient-Reported Quality-of-Life Assessment | Other | – |
Primary outcome
Results of the Amyotrophic Lateral Sclerosis Assessment Questionnaire (ALSAQ-40)
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).
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)
Time frame: 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.
1 secondary outcome
King's Clinical Severity Staging System
Time frame: Assessment will start at the initial visit, then every standard-of-care clinic visit, through study completion (assessed up to 2 years).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Amyotrophic Lateral Sclerosis and Motor Neuron Disease, run by TidalHealth, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Allison D Elerding, MS (410-912-6122, Allison.Elerding@tidalhealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Results of the Amyotrophic Lateral Sclerosis Assessment Questionnaire (ALSAQ-40) (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).). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2026.