Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT02144935 |
Other study ID # |
012014-077 |
Secondary ID |
012014-077 |
Status |
Completed |
Phase |
|
First received |
|
Last updated |
|
Start date |
May 2014 |
Est. completion date |
August 19, 2022 |
Study information
Verified date |
August 2022 |
Source |
University of Texas Southwestern Medical Center |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Observational [Patient Registry]
|
Clinical Trial 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.
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.