NCT07491484 Impact of Physical Functioning on Patient-Reported Outcomes in ALS Patients at TidalHealth
| NCT ID | NCT07491484 |
| Status | Recruiting |
| Phase | — |
| Sponsor | TidalHealth, Inc. |
| Condition | Amyotrophic Lateral Sclerosis |
| Study Type | OBSERVATIONAL |
| Enrollment | 30 participants |
| Start Date | 2025-07-03 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 30 participants in total. It began in 2025-07-03 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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. 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
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07491484 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Amyotrophic Lateral Sclerosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07491484 currently recruiting?
Yes, NCT07491484 is actively recruiting participants. Contact the research team at Allison.Elerding@tidalhealth.org for enrollment information.
Where is the NCT07491484 trial being conducted?
This trial is being conducted at Salisbury, United States.
Who is sponsoring the NCT07491484 clinical trial?
NCT07491484 is sponsored by TidalHealth, Inc.. The trial plans to enroll 30 participants.
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