Effect of Compliance Counseling on Brace Success in Patients With Idiopathic Scoliosis
Effect of Compliance Counseling on Brace Success in Patients With Idiopathic Scoliosis
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.
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.)
Inclusion Criteria:

 -  Male and female patients of all races and ethnic backgrounds between the ages of 10
 and 16, who have been or who are being treated for idiopathic scoliosis with a Boston
 brace at Texas Scottish Rite Hospital for Children. These patients will not have worn
 braces before and have scoliosis curves measuring from 25-45 degrees and are Risser 0,
 1, or 2. Female patients will be premenarchal or <1 year post menarchal.

 Exclusion Criteria:

 -  Patients with juvenile scoliosis (age less than 10 years), patients with
 non-idiopathic scoliosis, patients with curves measuring <25 degrees or >45 degrees at
 the time of brace prescription, patients previously treated with spinal surgery or
 orthoses, girls who are greater than one year postmenarchal, and patients who are
 Risser 3, 4, or 5.

 Furthermore, if during the course of treatment a diagnosis of non-idiopathic scoliosis,
 i.e. if a spinal cord abnormality such as a syrinx, becomes apparent, the previously
 enrolled patient will be excluded from the study.