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NCT05276349 · ClinicalTrials.gov registry record
Home-based Remote Digital Monitoring to Assess ALS Progression (Track ALS)
A clinical trial, sponsored by St. Joseph's Hospital and Medical Center, Phoenix.
- Completed
- Registry status
- 80
- Enrollment target
NCT05276349: Completed study, sponsored by St. Joseph's Hospital and Medical Center, Phoenix.
NCT05276349 is a clinical trial that has completed, run by St. Joseph's Hospital and Medical Center, Phoenix. The registered enrollment target is 80 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05276349 has completed, sponsored by St. Joseph's Hospital and Medical Center, Phoenix.
- COMPLETED
- Registry status
- 80 participants
- Enrollment target
Study Summary
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: 1. Can ALS patients measure important aspects of disease progression at home, either by themselves with appropriate training or with assistance of a coordinators via virtual visit? 2. Which clinical outcome measures collected through DHT are sensitive indicators of ALS progression? 3. Are the measures reproducible and whether they can correlate with gold standard assessments? 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
Primary Outcome
The average number of at-home assessments completed by each subject will be calculated each quarter using Wald method
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 80 participants |
| Start Date | 2022-02-21 |
| Est. Completion | 2024-08-28 |
What the finished NCT05276349 record still lists
NCT05276349 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 80 participants, a relatively small participant target.
The record links to 0 conditions, and to 0 interventions.
NCT05276349 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05276349 about?
NCT05276349 is a clinical study titled "Home-based Remote Digital Monitoring to Assess ALS Progression (Track ALS)". 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 ...
What is the current status of trial NCT05276349?
This trial is currently completed. The enrollment target is 80 participants. The study started on 2022-02-21. Estimated completion is 2024-08-28.
Who is sponsoring clinical trial NCT05276349?
This trial is sponsored by St. Joseph's Hospital and Medical Center, Phoenix, which has 44 total clinical trials registered on ClinicalTrials.gov.
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