Clinical Procedures to Support Research in ALS (CAPTURE-ALS)

Clinical Procedures to Support Research in ALS (CAPTURE-ALS)

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.

Study Overview

• Status: Recruiting
• Conditions: Amyotrophic Lateral Sclerosis; Primary Lateral Sclerosis; Progressive Muscular Atrophy; ALS-Frontotemporal Dementia

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.

• Study Type: Observational
• Enrollment (Estimated): 1200

Contacts and Locations

• Study Contact: Name: Michael Benatar, MBChB, MS, DPhil; Phone Number: 1-844-837-1031; Email: projectcreate@miami.edu
• Study Contact Backup: Name: Anne-Laure Grignon; Phone Number: 1-844-837-1031; Email: projectcreate@miami.edu

Study Locations

• United States
  • California
    • Irvine, California, United States, 92868
      • Recruiting
      • University of California, Irvine
      • Contact: Mercedes Herrera; Phone Number: 714-509-2665; Email: mercedh1@hs.uci.edu
      • Principal Investigator: Namita Goyal, MD
    • Palo Alto, California, United States, 94304
      • Recruiting
      • Stanford University
      • Contact: Rabia Farooquee; Phone Number: 650-709-8735; Email: rfarooquee@stanford.edu
      • Principal Investigator: Yuen T So, MD
    • San Francisco, California, United States, 94115
      • Recruiting
      • California Pacific Medical Center
      • Contact: Chow Saephanh; Phone Number: 415-600-3935; Email: SaephaC@cpmcri.org
      • Principal Investigator: Jonathan Katz, MD
  • Florida
    • Miami, Florida, United States, 33136
      • Recruiting
      • University of Miami
      • Contact: Jessica Hernandez; Phone Number: 305-243-2345; Email: jph93@miami.edu
      • Principal Investigator: Michael Benatar, MBChB, MS, DPhil
  • Kansas
    • Kansas City, Kansas, United States, 66205
      • Recruiting
      • University of Kansas Medical Center
      • Principal Investigator: Jeffrey Statland, MD
      • Contact: Osvaldo Plascencia; Phone Number: 913-945-9922; Email: oplascencia@kumc.edu
  • Minnesota
    • Minneapolis, Minnesota, United States, 55404
      • Recruiting
      • Hennepin County Medical Center
      • Contact: Daphne Fruchtman; Phone Number: 612-873-2607; Email: DFruchtman@hhrinstitute.org
      • Principal Investigator: Samuel Maiser, MD
  • New York
    • New York, New York, United States, 10032
      • Recruiting
      • Columbia University
      • Contact: Ben Hoover; Phone Number: 646-574-7399; Email: bnh2119@cumc.columbia.edu
      • Principal Investigator: Matthew Harms, MD
  • North Carolina
    • Durham, North Carolina, United States, 27708
      • Recruiting
      • Duke University
      • Contact: Hailey Zampa; Email: hailey.zampa@duke.edu
      • Principal Investigator: Xiaoyan Li
    • Winston-Salem, North Carolina, United States, 27157
      • Recruiting
      • Wake Forest University
      • Principal Investigator: James Caress, MD
      • Contact: Robert Ward; Phone Number: 336-716-9056; Email: raward@wakehealth.edu
  • Oregon
    • Portland, Oregon, United States, 97213
      • Recruiting
      • Providence Health & Services
      • Principal Investigator: Nicholas Olney, MD
      • Contact: Tyler Regan; Phone Number: 503-215-2333; Email: tyler.regan@providence.org
  • Texas
    • San Antonio, Texas, United States, 78229
      • Recruiting
      • University of Texas San Antonio Health Science Center
      • Principal Investigator: Carlayne Jackson, MD
      • Contact: Randee Kent-Baron; Email: kentbaron@uthscsa.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Affected patients receiving care at a clinical center that uses Epic as EHR.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Affected; Affected with ALS or a related disorder.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Using the ALS Toolkit for collecting and using electronic health record data for research purposes	12 months

Collaborators and Investigators

• Sponsor: University of Miami
• Collaborators: National Institute of Neurological Disorders and Stroke (NINDS); National Institutes of Health (NIH); National Center for Advancing Translational Sciences (NCATS); Muscular Dystrophy Association
• Investigators: Principal Investigator: Michael Benatar, MBChB, MS, DPhil, University of Miami

Study record dates

Study Major Dates

• Study Start (Actual): February 15, 2018
• Primary Completion (Estimated): June 1, 2024
• Study Completion (Estimated): June 1, 2024

Study Registration Dates

• First Submitted: March 23, 2018
• First Submitted That Met QC Criteria: April 4, 2018
• First Posted (Actual): April 5, 2018

Study Record Updates

• Last Update Posted (Actual): March 19, 2024
• Last Update Submitted That Met QC Criteria: March 18, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Metabolic Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Neurocognitive Disorders; Neuromuscular Diseases; Neurodegenerative Diseases; Neuromuscular Manifestations; Pathological Conditions, Anatomical; Spinal Cord Diseases; TDP-43 Proteinopathies; Proteostasis Deficiencies; Dementia; Atrophy; Language Disorders; Communication Disorders; Speech Disorders; Frontotemporal Lobar Degeneration; Aphasia; Sclerosis; Motor Neuron Disease; Amyotrophic Lateral Sclerosis; Muscular Atrophy; Frontotemporal Dementia; Aphasia, Primary Progressive; Pick Disease of the Brain; Muscular Atrophy, Spinal
• Other Study ID Numbers: 20170785; U54NS092091 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No