Clinical trial NCT03929614: Development and Validation of the MOBI Questionnaire
Official title: Development and Validation of the MOBI Questionnaire
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Idiopathic Scoliosis
Keywords: Brace Treatment
Health-related quality of life (HRQOL)
Questionnaire development
Lead sponsor: St. Justine's Hospital
Sponsor class: OTHER
Collaborators: name: Shriners Hospitals for Children
First posted: 2019-04-29
Enrollment: 176
Sex: ALL
Minimum age (years): 10
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: AIS patients with brace treatment.

Brief summary: Scoliosis is a common spinal deformity in adolescents. Orthopedic brace treatment is the only conservative (nonsurgical) treatment effective in limiting the progression of this deformity. It is a difficult treatment for young people (discomfort, self-image, limitation in activities) who must wear this rigid orthosis between 20-23 hrs / day during the growth spurt. Recent studies have shown that the effectiveness of this treatment is related to the wearing time of the corset. However, there is a serious problem of compliance to treatment. On average, the brace is worn only 12 hrs / day. A negative perception of the patient with respect to the brace can lead to treatment failure if the brace is not worn. It is therefore essential to understand the impact of the brace on the quality of psychological life, the daily activities and the comfort of young patients. Unfortunately, there is no valid instrument to evaluate all these dimensions. The objective of this project is to develop a questionnaire that can measure the quality of life of patients wearing a brace and validate it for its clinical use.

The investigators have created a questionnaire based on the best knowledge published on the subject, opinions of experts in the field and a group of patient partners.

At the end of this project, a questionnaire will be available for the first time to assess in depth the perception that patients have of their braces. It can be used to adjust braces in the clinic, as well as to support and encourage compliance to the treatment

Detailed description: Increase treatment adherence by 50%: 1- by identifying the reasons of non-adherence with MOBI, the first bilingual quality of life (QL) measurement questionnaire dedicated to braces, 2- using for the first time a Multidisciplinary Support Team (MST) for the patient / family.

The BrAIST study showed an inverse correlation between the duration of brace wear and the probability of progression, a wearing time of 0 to 6 hrs / day with a proportion at 59% progression ≥50 ° vs 7% for a brace wear\> 17 hours. Knowing that the average daily brace wear duration measured is much lower than that prescribed, there is a problem of compliance whose in which the causes are unknown. Unsuitable questionnaires assessed the QoL of AIS patients on TLSO and have reflected the impact of the disease on psychological health, perceptions of self-image and daily activities, but do not isolate the factors associated with non-compliance to TLSO. In addition, there is no biopsychosocial intervention strategy in care settings to improve compliance.

The investigators have expertise in this field since the investigator have carried out cross-cultural adaptation and validation of 2 QL instruments in the AIS. In addition, the investigator and his team developed a body diagram to evaluate the comfort of patients under brace treatment and correlated with pressure measurements at the skin-brace interface. The investigator's also used in a previous RCT thermal sensors to measure the wearing time of the braces.

The investigator's team propose to develop and validate MOBI (My Orthopedic Brace Inventory), the first bilingual multidimensional QL questionnaire dedicated to the wearing of the brace to measure the physical and functional well-being, emotional and social wellness. We will use MOBI to identify the elements associated with non-compliance to TLSO and for the first time in the world MST, a multi-disciplinary team (nurse, orthotist, psychologist, social worker) to intervene on the 4 identified dimensions, with the assumption that this intervention will improve by 50% the wearing time of the brace.

Eligibility criteria: Inclusion Criteria:

* AIS.
* 10-16 years old, with brace treatment.
* Ability to read and understand English or French.
* Physical and mental ability to adhere to bracing protocol.

Exclusion Criteria:

* Diagnosis of other musculoskeletal or developmental illness that might be responsible for the spinal curvature.
* Patients with symptom of a neurological disorder.
* Patients with any other disorder of the musculoskeletal system affecting the lower limbs,

Primary outcomes:
measure: Score distribution for the new MOBI questionnaire scales
timeFrame: At baseline (at recruitment)
measure: Internal validity, scale MOBI
timeFrame: At baseline (at recruitment)
measure: The test-retest reliability of MOBI questionnaire
timeFrame: At baseline (at recruitment)
measure: The structural validity of the MOBI questionnaire
timeFrame: At project completion (up to 48 months upon recruitment)
Secondary outcomes:
Other outcomes:
Locations:
city: Montréal
country: Canada
facility: CHU Sainte-Justine
state: Quebec
Study officials:
affiliation: Ste Justine's
name: Hubert Labelle, MD
role: PRINCIPAL_INVESTIGATOR
References: