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临床试验/NCT05152329
NCT05152329Unknown不适用

Investigating the Potential Psychological Impact of Early Screening and Long-term Monitoring for Adolescent Idiopathic Scoliosis Among Patients and Caregivers

The University of Hong Kong1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2021年2月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
150
试验地点
1
主要终点
General quality of life: European Quality of Life 5 Dimension

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
10 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Diagnosis of structural scoliosis, and
  • developmentally normal cognitive function

排除标准

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

结局指标

主要结局

General quality of life: European Quality of Life 5 Dimension

时间窗: Change from baseline health practices at 6 months

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'\[47\].

Health practices

时间窗: Change from baseline health practices at 6 months

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.

General quality of life: Short-Form Health Survey (SF-12)

时间窗: Change from baseline health practices at 6 months

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.

Parental Caregiving Experience - Overprotection

时间窗: Change from baseline health practices at 6 months

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.

Misconception

时间窗: Change from baseline health practices at 6 months

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).

Scoliosis-specific Quality of Life

时间窗: Change from baseline health practices at 6 months

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.

Body image

时间窗: Change from baseline health practices at 6 months

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.

Parental Caregiving Experience - parental distress

时间窗: Change from baseline health practices at 6 months

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.

Visual Analogue Scale

时间窗: Change from baseline health practices at 6 months

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'.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr. Kenny Kwan

Clinical Assistant Professor

The University of Hong Kong

研究点 (1)

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