ALS (Amyotrophic Lateral Sclerosis)NCT05276349
Home-based Remote Digital Monitoring to Assess ALS Progression (Track ALS)
An observational study of ALS (Amyotrophic Lateral Sclerosis), run by St. Joseph's Hospital and Medical Center, Phoenix at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- ALS (Amyotrophic Lateral Sclerosis)
- How many people
- 80 participants
- Where
- 2 sitesUnited States
- Study dates
- 21 Feb 2022to 28 Aug 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- Male or female, age 18 to 90.
- Diagnosed with definite, probable, or possible ALS according to the modified El Escorial Criteria (EEC) or diagnosed with ALS using the Gold Coast Criteria.
- Must be able to ambulate independently at the time of enrollment, with or without the use of foot braces or cane.
- A vital capacity score of ≥40% of the predicted value (at last known in-person visit and if available).
- Intelligible speech with occasional repetition.
- Willingness and medical ability to comply with scheduled visits and study procedures.
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- Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information (PHI).
- Possession of a smartphone, and willingness to install study apps on it.
- Continuous internet access at home, with stable broadband internet access.
- Sufficiently proficient in English to understand and complete questionnaires and follow instructions using smartphone apps.
Who cannot join
- Diagnosed with a superimposed medical condition that could confound study procedures in the opinion of the investigator.
- Unwilling or unable to comply with the requirements of this protocol, including the presence of any condition (physical, mental, or social) that is likely to affect the participant's ability to comply with the protocol.
- Any other reasons that, in the opinion of the PI, the candidate is determined to be unsuitable for entry into the study.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Emory University
Atlanta, Georgia, 30322
Barrow Neurological Institute
Phoenix, Arizona, 85013
About this study
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:
Read more
- 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?
- Which clinical outcome measures collected through DHT are sensitive indicators of ALS progression?
- 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
- Conditions
- ALS (Amyotrophic Lateral Sclerosis)
- Medical subject headings
- Amyotrophic Lateral Sclerosis
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of at-home assessments
The average number of at-home assessments completed by each subject will be calculated each quarter using Wald method
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2022
- Study start21 Feb 2022
- Primary completion12 Aug 2024
- Study completion28 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ALS (Amyotrophic Lateral Sclerosis)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Joseph's Hospital and Medical Center, Phoenix
- Sponsor type
- University, hospital or other
- Collaborators
- Emory University, Tanabe Pharma America, Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05276349
- Sponsor's protocol ID
- DHI-10012021-ALS
- Status last verified
- Nov 2024
- First submitted
- 2 Mar 2022
- Last updated
- 12 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Home-based Remote Digital Monitoring to Assess ALS Progression (Track ALS)
- ClinicalTrials.gov ID
- NCT05276349
- Acronym / sponsor ID
- DHI-10012021-ALS
- Conditions
- ALS (Amyotrophic Lateral Sclerosis)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- St. Joseph's Hospital and Medical Center, PhoenixUniversity, hospital or other
- Collaborators
- Emory University, Tanabe Pharma America, Inc.
- Study start
- 21 Feb 2022 (actual)
- Primary completion
- 12 Aug 2024 (actual)
- Study completion
- 28 Aug 2024 (actual)
- First posted
- 11 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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?
- Which clinical outcome measures collected through DHT are sensitive indicators of ALS progression?
- 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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (10 listed)
- Male or female, age 18 to 90.
- Diagnosed with definite, probable, or possible ALS according to the modified El Escorial Criteria (EEC) or diagnosed with ALS using the Gold Coast Criteria.
- Must be able to ambulate independently at the time of enrollment, with or without the use of foot braces or cane.
- A vital capacity score of ≥40% of the predicted value (at last known in-person visit and if available).
- Intelligible speech with occasional repetition.
Key exclusion criteria (3 listed)
- Diagnosed with a superimposed medical condition that could confound study procedures in the opinion of the investigator.
- Unwilling or unable to comply with the requirements of this protocol, including the presence of any condition (physical, mental, or social) that is likely to affect the participant's ability to comply with the protocol.
- Any other reasons that, in the opinion of the PI, the candidate is determined to be unsuitable for entry into the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Feasibility of at-home assessments
Time frame: 12 months
The average number of at-home assessments completed by each subject will be calculated each quarter using Wald method
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of ALS (Amyotrophic Lateral Sclerosis), run by St. Joseph's Hospital and Medical Center, Phoenix at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of at-home assessments (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Nov 2024.