HealthyAQUAPedNCT03286894
AQUAPed: Validation Study of AQUA© Questionnaire Modified for Childhood
An observational study of Healthy, run by Istituto per la Ricerca e l'Innovazione Biomedica at 1 site in Italy.
Trial summary
The AQUA© questionnaire developed in 2008 is a validated tools for the screening of allergic diseases in adult athletes. The objective of the present study is to develop and validate a modified version of the AQUA© questionnaire to be used in childhood. Read more about this study
- Who is it for?
- Ages 8 to 14 years
- Conditions the study is for
- Healthy
- How many people
- 1,264 participants
- Where
- 1 siteItaly
- Study dates
- 1 Sep 2017to 31 Dec 2017
- 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 8 to 14 years
- All sexes
- Child
Study population: The study population consists of 1264 healthy schoolchildren, both males and females, aged 8 to 14 years, recruited in 7 primary and secondary schools of the city of Palermo.
Who may be able to join
- Aforementioned sex and age criteria.
Who cannot join
- Respiratory infections in the previous 3 weeks;
- Immunological or metabolic systemic disease;
- Major malformations of the upper airways;
- Active smoker.
Trial locations and contacts
1 site in 1 country.
Italy1 site
Institute of Biomedicine and Molecular Immunology (IBIM), National Research Council
Palermo, Sicily, 90146
About this study
The AQUA© questionnaire developed in 2008 is a validated tools for the screening of allergic diseases in adult athletes. The objective of the present study is to develop and validate a modified version of the AQUA© questionnaire to be used in childhood. In this phase, the validation is intended to assess the reliability of the information collected through the AQUA© modified version: question difficulty and response patterns with respect to children characteristics (in particular age, sex and physical activity). In particular, the focus will be on the "core questions", i.e. the indicators of allergic disorders. This is a cross-sectional study on 1264 healthy schoolchildren aged 8 to 14 years.
- Conditions
- Healthy
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 |
|---|---|---|
| 1264 healthy schoolchildren | There is only one study group consisting of 1264 children recruited at school. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Question difficulty
Comprehensibility (or difficulty) of the questions, especially the "core questions", will be assessed by the percentages of non-response possibly stratified by children characteristics (in particular age, sex and physical activity).
Measured: Study end (4 months)
Secondary outcomes (2)
Patterns of missing response
Possible tendency to skip consecutive questions will be assessed by studying the association between the presence of missing (0 = answer missing, 1 = answer given) in sequence (tetrachoric correlation).
Measured: Study end (4 months)
Patterns of non-missing responses
Analysis of the distribution of non-missing responses, possibly stratified by children characteristics (in particular age, sex and physical activity).
Measured: Study end (4 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2017
- Study start1 Sep 2017
- Primary completion31 Dec 2017
- Study completion31 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 1,264 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituto per la Ricerca e l'Innovazione Biomedica
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stefania La Grutta, MD, Istituto per la Ricerca e l'Innovazione Biomedica
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03286894
- Sponsor's protocol ID
- 7/2017_D
- Acronym
- AQUAPed
- Status last verified
- Oct 2018
- First submitted
- 15 Sep 2017
- Last updated
- 24 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AQUAPed: Validation Study of AQUA© Questionnaire Modified for Childhood
- ClinicalTrials.gov ID
- NCT03286894
- Acronym / sponsor ID
- AQUAPed / 7/2017_D
- Conditions
- Healthy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,264 participants (actual)
- Lead sponsor
- Istituto per la Ricerca e l'Innovazione BiomedicaUniversity, hospital or other
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 31 Dec 2017 (actual)
- Study completion
- 31 Dec 2017 (actual)
- First posted
- 19 Sep 2017 (actual)
- 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.
The AQUA© questionnaire developed in 2008 is a validated tools for the screening of allergic diseases in adult athletes. The objective of the present study is to develop and validate a modified version of the AQUA© questionnaire to be used in childhood. In this phase, the validation is intended to assess the reliability of the information collected through the AQUA© modified version: question difficulty and response patterns with respect to children characteristics (in particular age, sex and physical activity). In particular, the focus will be on the "core questions", i.e. the indicators of allergic disorders. This is a cross-sectional study on 1264 healthy schoolchildren aged 8 to 14 years.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1264 healthy schoolchildren | – | –There is only one study group consisting of 1264 children recruited at school. |
Who may qualify
- Ages
- 8 to 14 years
- Sex
- All
- Age groups
- Child
- Study population
- The study population consists of 1264 healthy schoolchildren, both males and females, aged 8 to 14 years, recruited in 7 primary and secondary schools of the city of Palermo.
Key inclusion criteria (1 listed)
- Aforementioned sex and age criteria.
Key exclusion criteria (4 listed)
- Respiratory infections in the previous 3 weeks;
- Immunological or metabolic systemic disease;
- Major malformations of the upper airways;
- Active smoker.
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
Question difficulty
Time frame: Study end (4 months)
Comprehensibility (or difficulty) of the questions, especially the "core questions", will be assessed by the percentages of non-response possibly stratified by children characteristics (in particular age, sex and physical activity).
2 secondary outcomes
Patterns of missing response
Time frame: Study end (4 months)
Patterns of non-missing responses
Time frame: Study end (4 months)
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 24 Oct 2018.
Related trials for Healthy
Recruiting
Trained vs. Untrained: Lower Extremity Pressure Changes
Trained Athletes, Untrained
Not yet recruitingPhase 1
Comparison of Pharmacokinetic/Pharmacodynamic Characteristics and Safety of GZR101-80 Injection With Separately Injected, Simultaneous Doses of GZR33 Injection and Insulin Aspart
Healthy Participants
Active, not recruitingPhase 2
Effect of Equol Supplementation on Arterial Stiffness and Cognition in Healthy Volunteers
Arterial Stiffness, White Matter Lesions
Enrolling by invitationObservational study
Screening for Hematology Branch Protocols
Hematologic Disease and Disorders, Donors
RecruitingPhase 1
A Study of Single and Multiple Subcutaneous or Intravenous Doses of ADX-001 in Healthy Adults to Assess Safety, Effects, and Immune Response
Healthy
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Healthy, run by Istituto per la Ricerca e l'Innovazione Biomedica at 1 site in Italy.
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 1 inclusion and 4 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 24 Oct 2018. 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 Italy. 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?
Question difficulty (time frame: Study end (4 months)). 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 24 Oct 2018.