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

Part of paid clinical trials in Salisbury, Maryland.

Sponsor
TidalHealth, Inc.
Study ID
NCT07491484
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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

Study Details

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.

Key Dates

Start date
Jul 3, 2025
Status verified
Mar 2026
Primary completion
Dec 31, 2026
Completion
Jul 31, 2027

Study Design

Enrollment
30 participants (estimated)

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). ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
TidalHealth Peninsula Regional, Inc.SalisburyMaryland21801
Allison D Elerding, MS
[email protected]
410-912-6122

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TidalHealth Peninsula Regional, Inc.· Salisbury, MD

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