Clinical trial NCT05152329: Investigating the Potential Psychological Impact of Early Screening and Long-term Monitoring for Adolescent Idiopathic Scoliosis Among Patients and Caregivers
Official title: Investigating the Potential Psychological Impact of Early Screening and Long-term Monitoring for Adolescent Idiopathic Scoliosis Among Patients and Caregivers
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Adolescent Idiopathic Scoliosis
AIS
Scoliosis
Keywords: Psychological impact
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
First posted: 2021-12-09
Enrollment: 150
Sex: ALL
Minimum age (years): 10
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A total of 150 patients and their caregivers will be recruited. New referral cases to spine clinic for Adolescent Idiopathic Scoliosis.

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

1. Diagnosis of structural scoliosis, and
2. developmentally normal cognitive function

Exclusion Criteria:

1. A nonspinal cause of scoliosis, patients who do not intend to stay in this country for the duration of treatment, and
2. those who cannot fill in the questionnaires

Primary outcomes:
measure: Health practices
timeFrame: Change from baseline health practices at 6 months
measure: General quality of life: Short-Form Health Survey (SF-12)
timeFrame: Change from baseline health practices at 6 months
measure: General quality of life: European Quality of Life 5 Dimension
timeFrame: Change from baseline health practices at 6 months
measure: Visual Analogue Scale
timeFrame: Change from baseline health practices at 6 months
measure: Scoliosis-specific Quality of Life
timeFrame: Change from baseline health practices at 6 months
measure: Body image
timeFrame: Change from baseline health practices at 6 months
measure: Parental Caregiving Experience - parental distress
timeFrame: Change from baseline health practices at 6 months
measure: Parental Caregiving Experience - Overprotection
timeFrame: Change from baseline health practices at 6 months
measure: Misconception
timeFrame: Change from baseline health practices at 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Duchess of Kent Children's Hospital
Study officials:
References: