Clinical trial NCT03489278: Clinical Procedures to Support Research in ALS
Official title: Clinical Procedures to Support Research in ALS (CAPTURE-ALS)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Amyotrophic Lateral Sclerosis
ALS-Frontotemporal Dementia
Primary Lateral Sclerosis
Progressive Muscular Atrophy
Lead sponsor: University of Miami
Sponsor class: OTHER
Collaborators: name: Muscular Dystrophy Association
name: National Institute of Neurological Disorders and Stroke (NINDS)
name: National Center for Advancing Translational Sciences (NCATS)
name: National Institutes of Health (NIH)
First posted: 2018-04-05
Enrollment: 1200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Affected patients receiving care at a clinical center that uses Epic as EHR.

Brief summary: The purpose of the Clinical Procedures To Support Research (CAPTURE) study is to utilize information collected in the medical record to learn more about a disease called amyotrophic lateral sclerosis (ALS) and related disorders.

Detailed description: The study will consent patients with ALS or related disorders that are receiving care at a clinical center in the CReATe consortium that uses Epic as its electronic health record (EHR) system. The study aims to systematically gather a clinical dataset through the EHR using a standardized approach to characterize the natural history of ALS and related diseases.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of ALS or a related disorder (e.g. primary lateral sclerosis, progressive muscular atrophy).
* Receiving care at a clinical center that uses Epic as its EHR.
* Able and willing to provide informed consent (or informed consent obtainable from a designated proxy).

Exclusion Criteria:

* Inability to understand English and/or Spanish

Primary outcomes:
measure: Using the ALS Toolkit for collecting and using electronic health record data for research purposes
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Irvine
country: United States
facility: University of California, Irvine
state: California
city: Palo Alto
country: United States
facility: Stanford University
state: California
city: San Francisco
country: United States
facility: California Pacific Medical Center
state: California
city: Miami
country: United States
facility: University of Miami
state: Florida
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
city: Minneapolis
country: United States
facility: Hennepin County Medical Center
state: Minnesota
city: New York City
country: United States
facility: Columbia University
state: New York
city: Durham
country: United States
facility: Duke University
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest University
state: North Carolina
city: Portland
country: United States
facility: Providence Health & Services
state: Oregon
city: San Antonio
country: United States
facility: University of Texas San Antonio Health Science Center
state: Texas
Study officials:
affiliation: University of Miami
name: Michael Benatar, MBChB, MS, DPhil
role: PRINCIPAL_INVESTIGATOR
References: