Collaborative Assessment of Pediatric Transverse Myelitis: Understand, Reveal, Educate or CAPTURE Study
| Status: | Recruiting |
|---|---|
| Healthy: | No |
| Age Range: | Any - 17 |
| Updated: | 1/19/2019 |
| Start Date: | May 2014 |
| End Date: | September 2022 |
| Contact: | Tricia Plumb, RN, MSN |
| Email: | patricia.plumb@utsouthwestern.edu |
| Phone: | 214-456-2464 |
Patients and families are invited to participate in an online registry and data repository
specifically for patients with transverse myelitis. Their options are to join the data
repository only, or participate in a clinical sub study in conjunction with the database
repository. The data generated in this study will come from surveys, interviews, review of
medical records, and physical examinations.
Data from this study will be utilized to guide future clinical trials for children with an
acute case of Transverse Myelitis. Parents and children separately will fill out an online
data base with 7 banks of surveys, each bank of survey topics have 7-10 questions. We will
have both the parent and child fill out at time of symptom onset, and three time points to
follow, 3, 6, and 12 months post symptom onset.
A small subset of patients filling out the data registry will be able to travel to 1 of 5
treating TM centers; Children's Medical Center Dallas, Children's Hospital of Philadelphia,
Hospital for Sick Children (Toronto, CA), Kennedy Krieger Institute, or Johns Hopkins
University in Baltimore, MD for a physical examination highlighting recovery from Transverse
Myelitis.
specifically for patients with transverse myelitis. Their options are to join the data
repository only, or participate in a clinical sub study in conjunction with the database
repository. The data generated in this study will come from surveys, interviews, review of
medical records, and physical examinations.
Data from this study will be utilized to guide future clinical trials for children with an
acute case of Transverse Myelitis. Parents and children separately will fill out an online
data base with 7 banks of surveys, each bank of survey topics have 7-10 questions. We will
have both the parent and child fill out at time of symptom onset, and three time points to
follow, 3, 6, and 12 months post symptom onset.
A small subset of patients filling out the data registry will be able to travel to 1 of 5
treating TM centers; Children's Medical Center Dallas, Children's Hospital of Philadelphia,
Hospital for Sick Children (Toronto, CA), Kennedy Krieger Institute, or Johns Hopkins
University in Baltimore, MD for a physical examination highlighting recovery from Transverse
Myelitis.
There are two ways a child can be enrolled in this study, face to face and via internet. Both
cohorts 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.
Face to face: A face to face substudy will be completed at time of diagnosis or base line and
3 months if able to complete. And again at 6 and 12 months post diagnosis. For the sub study
in person study, children will undergo several outcomes measures highlighting physical
mobility. These outcomes will be completed at their regularly scheduled follow up visit.
There may be a case of a family electing to come to clinic as a research participant only.
Those rare cases will undergo the same online questionnaire and come to the Neurology clinic
at Children's Medical Center Dallas.
Via 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 CMCD research coordinator
information. It is up to the parent/guardian to contact the CRC from CMCD. 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 can give a user name and password for the online study. We will
send reminders to complete the 3 month, if applicable and the 6,12 month questionnaires to
the contact of the family's choosing: email, postal service, or telephone.
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.
We will invite families living outside of North America to participate in the online cohort
only. They need to be fluent in English, same as the North American cohort.
cohorts 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.
Face to face: A face to face substudy will be completed at time of diagnosis or base line and
3 months if able to complete. And again at 6 and 12 months post diagnosis. For the sub study
in person study, children will undergo several outcomes measures highlighting physical
mobility. These outcomes will be completed at their regularly scheduled follow up visit.
There may be a case of a family electing to come to clinic as a research participant only.
Those rare cases will undergo the same online questionnaire and come to the Neurology clinic
at Children's Medical Center Dallas.
Via 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 CMCD research coordinator
information. It is up to the parent/guardian to contact the CRC from CMCD. 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 can give a user name and password for the online study. We will
send reminders to complete the 3 month, if applicable and the 6,12 month questionnaires to
the contact of the family's choosing: email, postal service, or telephone.
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.
We will invite families living outside of North America to participate in the online cohort
only. They need to be fluent in English, same as the North American cohort.
Inclusion Criteria for the registry:
- 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 for the registry:
- Inability to provide appropriate consent or assent
- Diagnosis of multiple sclerosis, neuromyelitis optica, or neuromyelitis optica
spectrum disorder
Inclusion Criteria for clinical sub study:
- All inclusion for the registry study
- Ability to have clinic visits 3 months ,6 months and 12 months post symptom onset
Exclusion Criteria for clinical sub study:
- All exclusion criteria for the registry study
- Inability to take part in clinical assessments
We found this trial at
1
site
Dallas, Texas 75235
Principal Investigator: Benjamin Greenberg, MD
Phone: 214-456-2464
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