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

March 19, 2026 updated by: Allison Elerding, TidalHealth, Inc.

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:

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Allison D Elerding, MS
Phone Number: 410-912-6122
Email: Allison.Elerding@tidalhealth.org

Study Locations

United States
- Maryland
  - Salisbury, Maryland, United States, 21801
    - Recruiting
    - TidalHealth Peninsula Regional, Inc.
    - Contact:
      
      Allison D Elerding, MS
      
      Phone Number: 410-912-6122
      
      Email: Allison.Elerding@tidalhealth.org

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Adult
Older Adult

Accepts Healthy Volunteers

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

TidalHealth, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 3, 2025

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

July 1, 2027

Study Registration Dates

First Submitted

March 10, 2026

First Submitted That Met QC Criteria

March 19, 2026

First Posted (Actual)

March 24, 2026

Study Record Updates

Last Update Posted (Actual)