AsthmaQ-KAPNCT02464189
Assessment of Asthma Knowledge Perception in Parents of Asthmatic Children. Pilot Study by Means of Q-KAP ( Questionnaire on Knowledge, Attitudes and Practices )
An observational study of Asthma, run by Stefania La Grutta, MD at 1 site in Italy.
Trial summary
The aim of this study is to assess the knowledge, the attitudes and the practices of parents of asthmatic children. Read more about this study
- Who is it for?
- Ages 5 to 15 years
- Conditions the study is for
- Asthma
- What is being tested?
- Q-Kap
- How many people
- 390 participants
- Where
- 1 siteItaly
- Study dates
- Jun 2015to 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 5 to 15 years
- All sexes
- No healthy volunteers
- Child
Study population: 390 asthmatic children, recruited in the outpatient clinic of Pediatric Allergology \& Pulmonology (PAP) of Respiratory Disease Research Center (RDRC) within the Institute of Biomedicine and Molecular Immunology (IBIM) of the National Research Council (CNR) of Palermo (RDRC-IBIM CNR), Italy.
Who may be able to join
- Asthma
Who cannot join
- No consent by parents
Trial locations and contacts
1 site in 1 country.
Italy1 site
Institute of Biomedicine and Molecular Immunology, IBIM
Palermo, 90146
About this study
The aim of this study is to assess the knowledge, the attitudes and the practices of parents of asthmatic children.
Read the detailed description
The aim of this study is to assess the knowledge, the attitudes and the practices of parents of asthmatic children.
The study proposes the validation of Q- KAP by means of the recruiting of 390 parents of asthmatic children, recruited in the outpatient clinic of Pediatric Allergology \& Pulmonology (PAP) of Respiratory Disease Research Center (RDRC) within the Institute of Biomedicine and Molecular Immunology (IBIM) of the National Research Council (CNR) of Palermo (RDRC-IBIM CNR), Italy.
Q-KAP will be given to one of the parents during their children medical examination. Q-KAP is a multiple answer questionnaire investigating on knowledge, attitudes and practices for what concerns Asthma.
At the end of the recruitment time, data will be stored and analyzed in a dataset.
The expected result is the identification of a tool able to assess knowledge, attitudes and practices of asthmatic children parents, but also the identification of a tool able to identify two groups of parents (well-experienced and bad-experienced) to assess if there is a link between a low degree of knowledge and a bad control of the disease.
- Conditions
- Asthma
- Being tested
- Q-Kap
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Q-KapOther
| Study group | Role | What they receive |
|---|---|---|
| Children with asthma | Not described Receives: Other: Q-Kap |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knowledge, attitudes and practices of parents of asthmatic children assessment.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2015 (estimated)
- Study startJun 2015
- Primary completionDec 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 390 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stefania La Grutta, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Stefania La Grutta, MD, Istituto per la Ricerca e l'Innovazione Biomedica
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02464189
- Sponsor's protocol ID
- 10/2014
- Acronym
- Q-KAP
- Status last verified
- Jan 2018
- First submitted
- 3 Jun 2015
- Last updated
- 9 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: The IPD collected will be available on December 2016. The following participant data will be shared: * Asthma severity level * Asthma control level * Pulmonary function tests * Demographic characteristics All IPD will be obtained from statistical analysis on the dedicated database in which all data are stored.
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Asthma Knowledge Perception in Parents of Asthmatic Children. Pilot Study by Means of Q-KAP ( Questionnaire on Knowledge, Attitudes and Practices )
- ClinicalTrials.gov ID
- NCT02464189
- Acronym / sponsor ID
- Q-KAP / 10/2014
- Conditions
- Asthma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 390 participants (actual)
- Lead sponsor
- Stefania La Grutta, MDUniversity, hospital or other
- Study start
- Jun 2015
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 8 Jun 2015 (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.
The aim of this study is to assess the knowledge, the attitudes and the practices of parents of asthmatic children.
Detailed description
The aim of this study is to assess the knowledge, the attitudes and the practices of parents of asthmatic children.
The study proposes the validation of Q- KAP by means of the recruiting of 390 parents of asthmatic children, recruited in the outpatient clinic of Pediatric Allergology \& Pulmonology (PAP) of Respiratory Disease Research Center (RDRC) within the Institute of Biomedicine and Molecular Immunology (IBIM) of the National Research Council (CNR) of Palermo (RDRC-IBIM CNR), Italy.
Q-KAP will be given to one of the parents during their children medical examination. Q-KAP is a multiple answer questionnaire investigating on knowledge, attitudes and practices for what concerns Asthma.
At the end of the recruitment time, data will be stored and analyzed in a dataset.
The expected result is the identification of a tool able to assess knowledge, attitudes and practices of asthmatic children parents, but also the identification of a tool able to identify two groups of parents (well-experienced and bad-experienced) to assess if there is a link between a low degree of knowledge and a bad control of the disease.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Children with asthma | – | Other: Q-Kap |
Who may qualify
- Ages
- 5 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- 390 asthmatic children, recruited in the outpatient clinic of Pediatric Allergology \& Pulmonology (PAP) of Respiratory Disease Research Center (RDRC) within the Institute of Biomedicine and Molecular Immunology (IBIM) of the National Research Council (CNR) of Palermo (RDRC-IBIM CNR), Italy.
Key inclusion criteria (1 listed)
- Asthma
Key exclusion criteria (1 listed)
- No consent by parents
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Q-Kap | Other | Children with asthma |
Primary outcome
Knowledge, attitudes and practices of parents of asthmatic children assessment.
Time frame: 1 year
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 9 Jan 2018.
- Individual participant dataSharing planned: Yes. The IPD collected will be available on December 2016. The following participant data will be shared: * Asthma severity level * Asthma control level * Pulmonary function tests * Demographic characteristics All IPD will be obtained from statistical analysis on the dedicated database in which all data are stored.
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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.
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 Asthma, run by Stefania La Grutta, MD 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 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 9 Jan 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?
Knowledge, attitudes and practices of parents of asthmatic children assessment. (time frame: 1 year). 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 9 Jan 2018.