An observational study in Adolescent Idiopathic Scoliosis, AIS and Scoliosis, sponsored by The University of Hong Kong. Status unknown at 1 site in Hong Kong. Open to participants aged 10 Years to 18 Years. Per ClinicalTrials.gov, last updated 2021-12-09.
Sponsored by The University of Hong Kong · Observational
Adolescent Idiopathic scoliosis (AIS) is a three-dimensional deformity of the spine of unknown aetiology, characterised by a lateral curvature and vertebral rotation. Its prevalence is estimated to be 2.5% in children between aged 10 and 16 in Hong Kong. Despite concerns regarding the psycho-social issues patients face at and after AIS screening, there is no study that directly address this subject. The investigator propose to conduct a prospective longitudinal study on the psycho-social impact of AIS early screening and long-term monitoring amongst patients and their caregivers. The proposed study will bridge this research gap by evaluating a cohort of newly-diagnosed patients with AIS through the school screening program and their caregivers. A mixed-methods research approach to tap into the distinct social, behavioural, emotional and parental experiential profiles will be used. Patterns across different profiles can enhance the investigator's understanding of which aspects of AIS early screening and long-term monitoring can adversely affect patients' psychological well-being. Findings will facilitate targeted approaches to address specific psycho-social impact of scoliosis and its treatment, heighten compliance to long-term monitoring and prevention of scoliosis progression, and mobilise a new clinical care model that addresses patient and clinician concerns.
594 studies on the registry are indexed under Scoliosis; 139 are open to participants now.
This study's planned enrollment of 150 is above the median of 89 across 233 observational studies indexed under Scoliosis.
Browse Scoliosis studies →The University of Hong Kong is the lead sponsor of 1,262 studies on the registry; 340 are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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A total of 150 patients and their caregivers will be recruited. New referral cases to spine clinic for Adolescent Idiopathic Scoliosis.
Exclusion Criteria:
Health practices
Patients will answer questions about physical activity based on a modified version of the Paffenbarger Physical Activity Questionnaire \[45\], which includes questions about typical weekly energy expenditure and the duration of brisk physical activity per week. The activity score is obtained in units of kilocalorie/week, where a high value indicating high physical activity and a low value indicating low physical activity. There is no range for this scale.
Time frame: Change from baseline health practices at 6 months
General quality of life: Short-Form Health Survey (SF-12)
Generic Quality of life will be assessed through the 12-item Short-Form Health Survey (SF-12), which consists of 12 items in the physical and mental domains (Physical Component Summary (PCS)-12 and Mental Component Summary (MCS)-12; scoring range from 0-100). Higher PCS and MCS scale indicating better physical and mental health functioning.
Time frame: Change from baseline health practices at 6 months
General quality of life: European Quality of Life 5 Dimension
Generic quality of life will also be assessed through the European Quality of Life Five Dimension, which consists of five items (mobility, selfcare, usual activities, pain/discomfort and anxiety/depression). Classification scores can be linked to a utility score with 0 indicating 'death' and 1 indicating 'full health'\[47\].
Time frame: Change from baseline health practices at 6 months
Visual Analogue Scale
The European Quality of Life 5 Dimension (EQ-5D) is complemented by a visual analogue scale on current health, the valuation of own health, which is anchored at the lower end (0) by 'worst imaginable health state' and at the upper end (100) by 'best imaginable health state'.
Time frame: Change from baseline health practices at 6 months
Scoliosis-specific Quality of Life
Scoliosis-specific Quality of Life will be assessed through Scoliosis Research Society (SRS)-22, which consists of five domains: function/activity, pain, self-image/appearance, mental health and satisfaction with management. The SRS-22 standardises the quantification of an individual patient's views and comments in order to evaluate the results of treatment on a global basis. Each question from the SRS-22 consists of five options scored from 1 to 5. The higher the score, the more satisfied the patient is.
Time frame: Change from baseline health practices at 6 months
Body image
A modified version of the Body Image Disturbance Questionnaire (BIDQS) which specifically evaluates how scoliosis-related appearance concerns impact psychosocial and daily functioning will be used \[2\]. The BIDQ-S includes seven items that are scored on a scale of 1 to 5, with 5 being the highest level of body image disturbance. The overall score is calculated by obtaining the mean from all 7 questions, with score ranging from 7 to 35. A higher overall score indicating higher level of body image disturbance. In addition, the BIDQ-S includes qualitative questions inviting free text responses so that specific concerns and their impact on daily functioning can be assessed.
Time frame: Change from baseline health practices at 6 months
Parental Caregiving Experience - parental distress
Parental distress will be evaluated through the parental distress subscale of the Parenting Stress Index Short Form (PSI-SF). The subscale consisted of 12 items, rated from 1 (strongly disagree) to 5 (strongly agree), with subscales scores ranging from 12 to 60. A higher score would indicate higher level of parental distress.
Time frame: Change from baseline health practices at 6 months
Parental Caregiving Experience - Overprotection
The Overprotecting Parent Scale (VCOPS) will be used to index the degree to which the parent perceives participant's child being vulnerable and the degree to which participant display protective behaviors. VCOPS consisted of 28 items, rated from 1 "strongly agree" to 6 "strongly disagree", with score ranging from 28 to 168. A low score would indicate highly overprotective, whereas a high score would indicate an optimal level of overprotection.
Time frame: Change from baseline health practices at 6 months
Misconception
Parents will be asked to complete the True/False scale which include statements about AIS treatment options. Including this measure in the proposed study will allow us to ascertain the longitudinal predictors of continued AIS misconception(s).
Time frame: Change from baseline health practices at 6 months
This study is status unknown, as verified in Nov 2021. You cannot join it, but the record below documents what was studied.
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The University of Hong Kong