An observational study in ALS (Amyotrophic Lateral Sclerosis), sponsored by St. Joseph's Hospital and Medical Center, Phoenix. Completed at 2 sites in United States. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2024-11-12.
Sponsored by St. Joseph's Hospital and Medical Center, Phoenix · Observational
The purpose of this study is to study use of advance Digital Health Technologies (DHT) and its validity as measures for assessing progression in Amyotrophic Lateral Sclerosis (ALS) patients. A total of 80 ALS patients will be recruited across US, and will involve two sites - St. Joseph Hospital and Medical Center in Phoenix, AZ, and Emory University ALS Clinic in Atlanta. This will be a fully remote observational study and will employ remote data collection platforms such as (a) A digital spirometry device powered by a mobile app will be used to measure vital capacity; (b) A clinical-grade voice recording app will be used to evaluate speech function; (c) A medical-grade wearable sensor will be used to monitor activity levels and sleep patterns; and (d) Standardized Electronic Clinical Outcome Assessments (eCOA) and Patient Reported Outcomes (ePRO) will be used to evaluate quality of life and cognitive abilities.
The main goals of this study is to answer some of these questions:
The results of this study have the potential to provide valuable information for designing future ALS trials that are more decentralized, more patient-centric, and require less visits to the clinic which typically become a major burden with disease progression
717 studies on the registry are indexed under Motor Neuron Disease; 137 are open to participants now.
This study's enrollment of 80 is below the median of 109 across 217 observational studies indexed under Motor Neuron Disease.
Browse Motor Neuron Disease studies →St. Joseph's Hospital and Medical Center, Phoenix is the lead sponsor of 63 studies on the registry; 11 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 1 (20%) have results posted.
Counted across the registry records on this site, refreshed daily.
Patients will be recruited from the ALS patient populations cared for at the BNI and Emory University ALS Clinics. For the virtual recruitment of ALS patients outside of those clinics, the study details with contact information will be posted on IRB-approved websites, social media, and patient advocacy groups, including the Northeast ALS Consortium (NEALS), ALS Association (ALSA) websites and other ALS forums. The National ALS Registry will also be used to promote recruitment.
Exclusion Criteria:
Feasibility of at-home assessments
The average number of at-home assessments completed by each subject will be calculated each quarter using Wald method
Time frame: 12 months
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.
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St. Joseph's Hospital and Medical Center, Phoenix