Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT02412137 |
| Other study ID # |
112007-014 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
December 2007 |
| Est. completion date |
June 2020 |
Study information
| Verified date |
October 2021 |
| Source |
Texas Scottish Rite Hospital for Children |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
To measure the effectiveness of counseling on brace-wear compliance and curve progression in
patients with adolescent idiopathic scoliosis. The investigators hypothesize that compliance
is increased when it is measured and used to counsel patients, and therefore those patients
will have less curve progression and fewer would need surgery.
A second purpose is to evaluate whether there is a correlation between BMI and brace
effectiveness. Proposed theories for decreased effectiveness in patients with elevated BMI
have included decreased compliance due to discomfort and decreased force exerted on the curve
due to the larger habitus.
Description:
The investigators plan to enroll 300 subjects prospectively with the hypothesis that some
will be lost to followup, and would like a final number of at least 125 in each group. All
patients who fit the inclusion criteria and consent to participate in the study will have two
temperature monitors installed inside the padding in the front of their brace. The monitors
will sample temperature every hour, with room temperature and body temperature representing
periods of non-use and use respectively. Each temperature monitor is programmed to record
temperature sequentially, so that a longer period of time can be monitored in case the
patient's appointments get postponed beyond the time capacity of only one monitor. The
monitors will be downloaded into a laptop computer by an orthotist in the scoliosis clinic
each visit. A short questionnaire entitled the Brace Beliefs Questionnaire, consisting of 18
questions, will be administered to all patients at the time of brace prescription.
In approximately 50% of the patients, the information would be shared on each follow-up visit
with the nurses, orthotist, and physician. Patients are not going to be randomized as
communication in the clinic waiting room is common among braced patients. However, by having
all patients treated by a specific physician included in either the counseling group, or if
treated by a different physician in the standard care group, all patients in the waiting room
at a given time would be enrolled in a single arm of the study. The patient and parent will
then be given the visit's wear-time information and counseled regarding compliance using this
information. A standardized progress report (Brace Progress Report) will be completed by the
physician or orthotist.
In the other 50% of patients, only the person downloading the loggers would be aware of
wear-time and that information would not be shared with the medical staff. Those patients
will not receive detailed counseling regarding the actual hours of brace wear as documented
by the temperature loggers, but instead will receive routine clinical care including a
discussion about the importance of compliance. Radiographs routinely obtained in the clinic
will be measured by the Principle Investigator. No extra radiographs will be obtained based
on the participation in this study. The curve will be classified using the criteria of Lenke.
Scoliosis will be measured by the Cobb angle technique and the Risser sign charted. Curve
progression will be defined as progression of greater than or equal to six degrees. Patients
with progression to greater than 45 degrees, who have surgery recommended, or who undergo
spinal fusion surgery will be noted.
Enrollment and follow-up, gathering data, and analysis of that prospective data from 200
subjects is estimated to take approximately 5 years. We will not disclose to the subjects
that information from the temperature monitors can be used to monitor compliance because such
disclosure would change the purpose of the study.
With permission of the authors (Katz, et al, 2010) we will utilize de-identified BMI and
brace compliance data from the 100 patients who completed their previous study. This data
will be combined with the same information obtained from patient participation in this study
since both studies essentially used the same method for measuring patient brace wear
compliance. The increased numbers should lend stronger evidence to the findings. A target
accrual number of 300 is expected (100 with de-identified retrospective data and 200
prospective study subjects).
SOURCES OF RESEARCH MATERIAL: Existing diagnostic data could come from the patients' medical
records and radiographs, but temperature/date/time information downloaded from the loggers,
data from the Brace Beliefs Questionnaire, and data recorded in the Brace Progress Report
will be obtained specifically for research. Identifiable data obtained specifically for
research purposes will be used to answer the study questions. Any data resulting from
radiographic studies will be standard of care that is associated with the patient's clinical
treatment, so no x-rays will be included for research purposes in this study.
The following information will be collected:
- Patient name/ID
- Age
- Gender
- Demographic information necessary to initiate contact with patient, including telephone
numbers, address or language
- Date and results of physical exams from clinical records and radiographic studies
- Treatment history (surgical and non-surgical) and complications of treatment
- Temperature/date/time data downloaded from logger
- Data from short questionnaire (Brace Beliefs Questionnaire)
- Documentation of counseling session with patients who are in the counseling group using
Brace Progress Report.
- Documentation of no counseling session in the "no counseling" group along with the
amount of their brace wear compliance as recorded in the Brace Progress report.
- For the purpose of reporting any correlation between brace effectiveness and BMI,
deidentified data from 100 patients previously enrolled in IRB#0598-2220 will be merged
with the same data collected from physical exams and brace compliance data from this
study.
RECRUITMENT OF SUBJECTS: Patients will be identified face-to-face as candidates for the study
by the treating physician or orthotist at the scoliosis clinics at Texas Scottish Rite
Hospital for Children as they present to clinic for diagnosis and treatment of their
idiopathic scoliosis when the brace is initially prescribed. They will be invited, all study
procedures will be explained to them, and they will be encouraged to have any questions
answered. All patients will be informed that temperature loggers are going to be inserted in
their orthoses, and that temperature information will be downloaded at each visit. Only the
group that will receive counseling will be informed that the temperature information is a
measure of brace compliance. The other group will not be informed that the temperature
information indicates whether or not, and how often, the brace is worn. Informing them that
the logger measures compliance would influence the outcome of the study, and therefore cannot
be shared with the patients.
Study Procedures Screening Procedures Subjects will be identified and screened according to
the inclusion/exclusion criteria as they present to clinic and are referred by their
respective physicians to the Orthotics Department for bracing. This referral is standard
clinical procedure.
Study Intervention After the study subject accepts the invitation to participate in the
study, they will be asked to sign the consent documents and given copies for their records.
The Research Coordinator will record documentation of the recruitment process, invitation to
participate in the study, and informed consent on an Invitation Checklist. Subjects are
routinely assigned randomly into one of seven orthopaedic physician's clinics on their first
visit. Which of the two study groups they belong to will be determined by which physician is
seeing them. All physician staff Orthopedists at TSRH have agreed to participate in this
study and are listed as sub-investigators.The Principle Investigator will draw physician
names to determine which ones will be receiving information about bracewear compliance that
is downloaded from the monitors and then provide counseling to their patients, and which
physician staff will not be receiving information about bracewear compliance at the patient
visits, and thus will not be providing additional counseling based on this information.
(1.One group will be counseled after brace temperature/date/time data is logged at each
visit. 2. The other group will receive routine clinical care including a discussion about the
importance of compliance.)
Procedures and Evaluations All subjects will be fitted by the Orthotist with a customized
scoliosis brace that includes the two temperature logger discs (about the size of a nickel
coin) which are fitted into the felt lining of the inside front of the brace. The subject
will be given their first set of instructions regarding wear and care of the brace (standard
clinical procedure) along with the Brace Beliefs Questionnaire (which should take less than
10 minutes and is being done specifically for research purposes. If the patient expresses
anxiety at answering questions, they will asked whether they want to continue). At every
subsequent clinic follow-up visit (see Follow-up below for frequency and duration), the
counseling group will have their brace wear compliance documented on the Brace Progress
Report after the Orthotist downloads the time/temperature data onto a laptop from the sensor
reader (A piece of computer hardware which the sensor clips into and is attached to the
laptop via the USB port). The Orthotist will then reset the temperature logger discs and
reinstall them into the padding in the inside front of the brace in order to monitor the next
period of brace wear. Depending on which group the patient has been assigned to, they will
either be counseled for about 10 minutes or less regarding their brace-wear using the Brace
Progress report as a checklist, or receive standard clinical care. Ideally, counseling would
be done by the treating physician (standard clinical care) using the Bracing Progress Report
Form (done for research purposes only). Counseling may also be done by nurse coordinators
involved in the patient's care (which is standard clinical care) utilizing the same Bracing
Progress Report Form if the treating physician is not available to do it. Data from the Brace
Beliefs Questionnaire will be used to discover the subject's initial attitude about wearing
the brace. Brace wear compliance data received from counseled patients will be compared to
the same data received from the patients who have received standard clinical care to see
whether counseling makes a difference in their compliance and thus their clinical outcomes.
Follow-up Patients will be followed for the duration of their bracing, which typically lasts
approximately one to four years, and depends on the rate of their growth and curve
progression. Data will be collected each time they present to clinic for follow-up, on
average two to three times per year. Each patient will be followed until skeletally mature,
two years following brace discontinuation, or until spinal fusion surgery is performed. Final
outcomes (whether or not they progress to surgery) will be included in the data collected for
this study.)
