Home-based Remote Digital Monitoring to Assess ALS Progression (Track ALS)

NCT05276349 | Completed

• 1 other identifier: DHI-10012021-ALS
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 2

Brief 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. 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. 2.Which clinical outcome measures collected through DHT are sensitive indicators of ALS progression?
3. 3.Are the measures reproducible and whether they can correlate with gold standard assessments?

Conditions

ALS (Amyotrophic Lateral Sclerosis)

Outcome Measures

Primary Outcomes (1)

• Feasibility of at-home assessments

  The average number of at-home assessments completed by each subject will be calculated each quarter using Wald method

  12 months

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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.

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• St. Joseph's Hospital and Medical Center, Phoenix: lead
• Emory University: collaborator
• Tanabe Pharma America, Inc.: collaborator

Study Sites (2)

Barrow Neurological Institute

Phoenix, Arizona, 85013, United States

Location

Emory University

Atlanta, Georgia, 30322, United States

Location

MeSH Terms

Conditions

Amyotrophic Lateral Sclerosis

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Motor Neuron Disease; Neurodegenerative Diseases; TDP-43 Proteinopathies; Neuromuscular Diseases; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 2, 2022
• First Posted: March 11, 2022
• Study Start: February 21, 2022
• Primary Completion: August 12, 2024
• Study Completion: August 28, 2024
• Last Updated: November 12, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)