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

NCT07491484 | Recruiting

• 1 other identifier: P25-007
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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. 1.Assess if there is a statistically significant correlation between patient's functionality scores (ALSFRS-R) and quality of life scores (ALSAQ-40).
2. 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).

Conditions

Amyotrophic Lateral Sclerosis; Motor Neuron Disease

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

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  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

  Assessment will start at the initial visit, then every standard-of-care clinic visit, through study completion (assessed up to 2 years).

Interventions

Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised OTHER

Patient-Reported Functionality Assessment

Amyotrophic Lateral Sclerosis Assessment Questionnaire-40 OTHER

Patient-Reported Quality-of-Life Assessment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• TidalHealth, Inc.: lead

Study Sites (1)

TidalHealth Peninsula Regional, Inc.

Salisbury, Maryland, 21801, United States

RECRUITING

MeSH Terms

Conditions

Amyotrophic Lateral Sclerosis; Motor Neuron Disease

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurodegenerative Diseases; TDP-43 Proteinopathies; Neuromuscular Diseases; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases

Central Study Contacts

Allison D Elerding, MS

CONTACT

410-912-6122; Allison.Elerding@tidalhealth.org

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Research Coordinator

Study Record Dates

• First Submitted: March 10, 2026
• First Posted: March 24, 2026
• Study Start: July 3, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): July 1, 2027
• Last Updated: March 24, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)