Collaborative Assessment of Pediatric Transverse Myelitis: Understand, Reveal, Educate or CAPTURE Study

NCT ID: NCT02144935

Last Updated: 2022-08-23

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 106 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-05-31
• Study Completion Date: 2022-08-19

Brief Summary

Patients and families are invited to participate in an online registry and data repository specifically for patients with transverse myelitis (TM) or acute flaccid myelitis (AFM). The data generated in this study will come from surveys, interviews, review of medical records.

Data from this study will be utilized to guide future clinical trials for children with an acute case of TM or AFM. Parents and school aged children will complete an online survey 7 banks of questions. Each bundle of survey topics have 7-10 questions. We will have both the parent and child complete a outcomes based survey within 6 months of diagnosis and invite to participate every 4 months until study end in 2024.

Detailed Description

Both parent and child will participate in the online questionnaires. The validated questionnaires, PROMIS or Patient-Reported Outcomes Measurement Information System, are blocks of 8-10 questions. 7 blocks of questions for the parent and 7 similar blocks for the child: anxiety, depressive symptoms, fatigue, mobility, pain interference, peer relationships, upper extremity function.

Participation via the Internet: When a child or family enters the Transverse Myelitis Association (TMA) website, they will be directed to information about the CAPTURE study. If the family is interested in participation, the TMA will give them the UT southwestern in Dallas, TX research coordinator information. It is up to the parent/guardian to contact the study staff from University Texas Southwestern. Once initial contact is complete, at the family's request, study staff will send the consent form to the interested family. The family will need to email or mail the consent back. Once the signed consent form is in hand, we will send the research survey to the email the parent provides. One survey for the parent, a separate but similar survey for a school aged child.

We will invite parents of school aged children to complete a school survey. This is a one time only questionnaire. Ideally, the parents will complete this either 6 months or 1 year into their child's recovery of TM/AFM.

We invite families living outside of North America to participate in the online survey. They need to be fluent in English, same as the North American cohort.

Conditions

Myelitis, Transverse; Flaccid Paraplegia, Complete, Acute; Flaccid Paraplegia, Incomplete, Acute

Study Design

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

Study Groups

myelitis, transverse or acute flaccid myelitis

Observational study with online survey participation highlighting outcomes recovery. The surveys can be completed by the child and parent, or if too young to participate, parent only. The survey asks how the child is doing after hospitalization within 6 months of diagnosis, and every 4 months until study end in 2024.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Diagnosis of transverse myelitis (TM) or acute flaccid myelitis (AFM)
• Patient is within 6 months of symptom onset
• Ability of patent or legal guardian is able to provide informed consent
• Ability of a child 10 or older able to provide assent
• Access to the internet

Exclusion Criteria

• Inability to provide appropriate consent or assent
• Diagnosis of multiple sclerosis, neuromyelitis optica, or neuromyelitis optica spectrum disorder

• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Patient-Centered Outcomes Research Institute

OTHER

Sponsor Role: collaborator

University of Texas Southwestern Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Benjamin Greenberg

Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Benjamin Greenberg, MD

Role: PRINCIPAL_INVESTIGATOR

UT Southwestern

Locations

UTexasSouthwestern

Dallas, Texas, United States

Countries

United States

Related Links

http://www.myelitis.org

Transverse Myelitis Association

Other Identifiers

012014-077

Identifier Type: OTHER

Identifier Source: secondary_id

012014-077

Identifier Type: -

Identifier Source: org_study_id