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

NCT ID: NCT05276349

Last Updated: 2024-11-12

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 80 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-02-21
• Study Completion Date: 2024-08-28

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. 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

Conditions

ALS (Amyotrophic Lateral Sclerosis)

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

1. Male or female, age 18 to 90.

2. Diagnosed with definite, probable, or possible ALS according to the modified El Escorial Criteria (EEC) or diagnosed with ALS using the Gold Coast Criteria.

3. Must be able to ambulate independently at the time of enrollment, with or without the use of foot braces or cane.

4. A vital capacity score of ≥40% of the predicted value (at last known in-person visit and if available).

5. Intelligible speech with occasional repetition.

6. Willingness and medical ability to comply with scheduled visits and study procedures.

7. 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).

8. Possession of a smartphone, and willingness to install study apps on it.

9. Continuous internet access at home, with stable broadband internet access.

10. Sufficiently proficient in English to understand and complete questionnaires and follow instructions using smartphone apps.

Exclusion Criteria

1. Diagnosed with a superimposed medical condition that could confound study procedures in the opinion of the investigator.

2. 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.

3. Any other reasons that, in the opinion of the PI, the candidate is determined to be unsuitable for entry into the study.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Emory University

OTHER

Sponsor Role: collaborator

Mitsubishi Tanabe Pharma America Inc.

INDUSTRY

Sponsor Role: collaborator

St. Joseph's Hospital and Medical Center, Phoenix

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Barrow Neurological Institute

Phoenix, Arizona, United States

Emory University

Atlanta, Georgia, United States

Countries

United States

Other Identifiers

DHI-10012021-ALS

Identifier Type: -

Identifier Source: org_study_id