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Adolescent Idiopathic ScoliosisNCT05152329

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

An observational study of Adolescent Idiopathic Scoliosis and AIS, run by The University of Hong Kong at 1 site in Hong Kong.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 10 to 18 years
Conditions the study is for
Adolescent Idiopathic Scoliosis, AIS, Scoliosis
How many people
150 participants
Where
1 siteHong Kong
Study dates
1 Feb 2021to Feb 2023
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 10 to 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Study population: A total of 150 patients and their caregivers will be recruited. New referral cases to spine clinic for Adolescent Idiopathic Scoliosis.

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Dr. Kenny Kwan, BMBCh (Oxon) contact

+852 22554654

kyhkwan@hku.hk

Amanda Liu, BS contact

+852 22554654

amanda91@hku.hk

Hong Kong1 site, 1 recruiting

  • Duchess of Kent Children's Hospital

    Hong Kong

    Dr. Kenny Kwan, BMBCh (Oxon), +852 22554654, kyhkwan@hku.hk

    Amanda Liu, BS, +852 22554654, amanda91@hku.hk

    Recruiting

Other trials in Hong Kong

About this study

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.

Keywords
Psychological impact
Medical subject headings
Scoliosis

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Change from baseline health practices at 6 months

  2. 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.

    Measured: Change from baseline health practices at 6 months

  3. 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].

    Measured: Change from baseline health practices at 6 months

  4. 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'.

    Measured: Change from baseline health practices at 6 months

  5. 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.

    Measured: Change from baseline health practices at 6 months

  6. 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.

    Measured: Change from baseline health practices at 6 months

  7. 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.

    Measured: Change from baseline health practices at 6 months

  8. 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.

    Measured: Change from baseline health practices at 6 months

  9. 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).

    Measured: Change from baseline health practices at 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Dec 2021
  2. Study start1 Feb 2021
  3. Primary completionDec 2022 (estimated)
  4. Study completionFeb 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
150 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05152329
Sponsor's protocol ID
UW19-088
Status last verified
Nov 2021
First submitted
28 Sep 2021
Last updated
9 Dec 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Adolescent Idiopathic Scoliosis and AIS, run by The University of Hong Kong at 1 site in Hong Kong.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 9 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Dr. Kenny Kwan, BMBCh (Oxon) (+852 22554654, kyhkwan@hku.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Health practices (time frame: Change from baseline health practices at 6 months). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05152329.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2021.

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