Ignite Creation Date:
2024-05-06 @ 2:51 AM
Last Modification Date:
2024-10-26 @ 11:24 AM
Study NCT ID:
NCT02144935
Status:
COMPLETED
Last Update Posted:
2022-08-23
First Post:
2014-05-19
Brief Title:
Collaborative Assessment of Pediatric Transverse Myelitis Understand Reveal Educate or CAPTURE Study
Sponsor:
University of Texas Southwestern Medical Center
Organization:
University of Texas Southwestern Medical Center
Study Overview
Official Title:
Collaborative Assessment of Pediatric Transverse Myelitis Understand Reveal Educate or CAPTURE Study
Status:
COMPLETED
Status Verified Date:
2022-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TMCAPTURE
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
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 parentguardian to contact the study staff from University Texas Southwestern Once initial contact is complete at the familys 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 childs recovery of TMAFM
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
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 parentguardian to contact the study staff from University Texas Southwestern Once initial contact is complete at the familys 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 childs recovery of TMAFM
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 012014-077 | OTHER | UTSW IRB | None |