Idiopathic ScoliosisP vs INCT01772459
Paper vs. Internet
An observational study of Idiopathic Scoliosis and Adolescent, run by University of British Columbia at 1 site in Canada.
Trial summary
Research has shown that questionnaires completed on the internet have the potential to provide more complete and honest data with fewer errors in a more efficient manner than questionnaires completed using the paper and pencil format. Read more about this study
- Who is it for?
- Ages 10 to 18 years
- Conditions the study is for
- Idiopathic Scoliosis, Adolescent
- How many people
- 139 participants
- Where
- 1 siteCanada
- Study dates
- Aug 2010to Nov 2013
- 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: Adolescents with idiopathic scoliosis will be asked to participate during visits to the orthopaedic spine clinic at BC Children's Hospital
Who may be able to join
- Aged 10-18
- Male or female
- Diagnosis of Adolescent or Juvenile Idiopathic Scoliosis
- Home access to computer and internet
- Capable or oral and written communication in English
Who cannot join
- Unable to communicate in English
Trial locations and contacts
1 site in 1 country.
Canada1 site
British Columbia Children's Hospital
Vancouver, British Columbia, V6H 3V4
About this study
Official title: Internet-administered Adolescent Scoliosis Questionnaires Compared With Traditional Pencil and Paper Versions: a Randomized Crossover Design
Research has shown that questionnaires completed on the internet have the potential to provide more complete and honest data with fewer errors in a more efficient manner than questionnaires completed using the paper and pencil format. Despite the numerous advantages of internet-administered questionnaires, it is important to make sure that the internet questionnaires will yield comparable results to the well-established paper and pencil versions. No one has studied internet administration of scoliosis specific questionnaires in adolescents with scoliosis. The investigators will test whether the internet administration of scoliosis questionnaires is as reliable as the traditional paper and pencil version. The investigators predict that the internet-administered questionnaire will provide the same reliability as the paper-administered questionnaires.
- Conditions
- Idiopathic Scoliosis, Adolescent
- Keywords
- Scoliosis, Adolescents, Questionnaire, Reliability
- Medical subject headings
- Scoliosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Paper/Paper | This group will complete paper questionnaires at baseline and two week follow up. | |
| Paper/Internet | This group will complete paper questionnaires at baseline and internet questionnaires at two week follow up. | |
| Internet/Paper | This group will complete internet questionnaires at baseline and paper questionnaires at two week follow up. | |
| Internet/Internet | This group will complete internet questionnaires at baseline and two week follow up. |
What is being measured
The primary outcome is the main question the study is designed to answer.
To test the reliability of the internet-administered PODCI and SRS-30 questionnaires in adolescents with idiopathic scoliosis
The reliability of internet-administered questionnaires will be determined by comparison to standard paper questionnaire implementation.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2013 (estimated)
- Study startAug 2010
- Primary completionNov 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic ScoliosisStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 139 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- iACT - Innovations in Acute Care and Technology
- Responsible party
- Sponsor
- Investigators
- Chris Reilly, MD, FRCSC, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01772459
- Sponsor's protocol ID
- H10-01785
- Other IDs
- CW10-0184
- Acronym
- P vs I
- Status last verified
- Jun 2014
- First submitted
- 17 Jan 2013
- Last updated
- 23 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Internet-administered Adolescent Scoliosis Questionnaires Compared With Traditional Pencil and Paper Versions: a Randomized Crossover Design
- ClinicalTrials.gov ID
- NCT01772459
- Acronym / sponsor ID
- P vs I / H10-01785
- Conditions
- Idiopathic Scoliosis, Adolescent
- Keywords
- Scoliosis, Adolescents, Questionnaire, Reliability
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 139 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Collaborators
- iACT - Innovations in Acute Care and Technology
- Study start
- Aug 2010
- Primary completion
- Nov 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 21 Jan 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Research has shown that questionnaires completed on the internet have the potential to provide more complete and honest data with fewer errors in a more efficient manner than questionnaires completed using the paper and pencil format. Despite the numerous advantages of internet-administered questionnaires, it is important to make sure that the internet questionnaires will yield comparable results to the well-established paper and pencil versions. No one has studied internet administration of scoliosis specific questionnaires in adolescents with scoliosis. The investigators will test whether the internet administration of scoliosis questionnaires is as reliable as the traditional paper and pencil version. The investigators predict that the internet-administered questionnaire will provide the same reliability as the paper-administered questionnaires.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Paper/Paper | – | –This group will complete paper questionnaires at baseline and two week follow up. |
| Paper/Internet | – | –This group will complete paper questionnaires at baseline and internet questionnaires at two week follow up. |
| Internet/Paper | – | –This group will complete internet questionnaires at baseline and paper questionnaires at two week follow up. |
| Internet/Internet | – | –This group will complete internet questionnaires at baseline and two week follow up. |
Who may qualify
- Ages
- 10 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Adolescents with idiopathic scoliosis will be asked to participate during visits to the orthopaedic spine clinic at BC Children's Hospital
Key inclusion criteria (5 listed)
- Aged 10-18
- Male or female
- Diagnosis of Adolescent or Juvenile Idiopathic Scoliosis
- Home access to computer and internet
- Capable or oral and written communication in English
Key exclusion criteria (1 listed)
- Unable to communicate in English
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To test the reliability of the internet-administered PODCI and SRS-30 questionnaires in adolescents with idiopathic scoliosis
Time frame: 2 weeks
The reliability of internet-administered questionnaires will be determined by comparison to standard paper questionnaire implementation.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chris Reilly, MD, FRCSC principal investigator
University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Idiopathic Scoliosis and Adolescent, run by University of British Columbia at 1 site in Canada.
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 5 inclusion and 1 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: finished, as of the sponsor's last update on 23 Jun 2014. 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 Canada. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To test the reliability of the internet-administered PODCI and SRS-30 questionnaires in adolescents with idiopathic scoliosis (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Jun 2014.