AsthmaTEPNCT02636920
Study and Development of Application Models of "Therapeutic Education to the Patient" (TEP) in Asthmatic Children
A study testing Therapeutic Education to the Patient (TEP) in people with Asthma, run by Stefania La Grutta, MD at 1 site in Italy.
Trial summary
It is an interventional prospective study. The study will assess the intervention of the "Therapeutic Education to the Patient (TEP)" on the quality of life in asthmatic children. Read more about this study
- Who is it for?
- Ages 6 to 11 years
- Conditions the study is for
- Asthma
- What is being tested?
- Therapeutic Education to the Patient (TEP)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteItaly
- Study dates
- 1 Mar 2017to 31 Aug 2017
- Phase
- Interventional
- 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 6 to 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Diagnosis of asthma
Who cannot join
- Acute respiratory infection signs
- Immunologic and metabolic systemic disease
- Major malformation of upper respiratory tract
- Active smokers patients
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
It is an interventional prospective study. The study will assess the intervention of the "Therapeutic Education to the Patient (TEP)" on the quality of life in asthmatic children.
The patients will be enrolled from the 1st of May 2016 to the 31st of December 2016 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.
Read the detailed description
It is an interventional prospective study. The study will assess the intervention of the "Therapeutic Education to the Patient (TEP)" on the quality of life in asthmatic children.
The patients will be enrolled from the 1st of May 2016 to the 31st of December 2016 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.
25 Case Patients will follow the Therapeutic Education to the Patient (TEP) and 25 Control Patients will follow the usual care program.
The following procedures will be performed:
- Pediatric Asthma Quality of Life Questionnaire (PAQLQ);
- Children Asthma Control Test (C-ACT);
- Pediatric Caregiver Asthma Quality of Life Questionnaire (PCAQLQ);
- Familiar Empowerment Scale (FES);
- Functional respiratory tests: forced expiratory volume in one second (FEV1), forced expiratory flow between 25% and 75% (FEF 25-75), forced vital capacity (FVC) and Peak expiratory flow (PEF); in addition, FEV1 and PEF will be daily recorded through the SmartOne device (Medical International Research s.r.l.), a portable flow peak meter for smartphones;
- Evaluation of the presence of Cotinine and Nicotine from Hair and Urine analysis respectively;
- Evaluation of levels of exposure to polycyclic aromatic hydrocarbons (PAH) through urine analysis.
Data collection about asthma control, quality of life and spirometry will be managed through DragONE, a downloadable APP for smartphones.
- Conditions
- Asthma
- Being tested
- Therapeutic Education to the Patient (TEP)
- Keywords
- Asthma, Children
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Therapeutic Education to the Patient (TEP)Other
Also called TEP
- Educational Diagnosis, asking what patient has, what he knows, what he is doing, what he would like to do.
- Therapeutic Contract, to define objectives to reach at the end of educational path, integrating new knowledges and replacing wrong cognitive-behavior models with new schemes.
- Educational Therapeutic Intervention, with individual or group methodologies (Role Playing, Brain Storming) and a disease diary in which patients could describe symptoms, therapies, behaviors and benefits.
- Assessing of the knowledges acquired by patients.
| Study group | Role | What they receive |
|---|---|---|
| TEP-CASES | Other | 25 Case Patients will follow the Therapeutic Education to the Patient (TEP).
In addition the following procedures will be performed:
* Pediatric Asthma Quality of Life Questionnaire (PAQLQ);
* Children Asthma Control Test (C-ACT);
* Pediatric Caregiver Asthma Quality of Life Questionnaire (PCAQLQ);
* Functional respiratory tests: forced expiratory volume in one second (FEV1), forced expiratory flow between 25% and 75% (FEF 25-75), forced vital capacity (FVC) and Peak expiratory flow (PEF) Receives: Other: Therapeutic Education to the Patient (TEP) |
| TEP-CONTROLS | No intervention | 25 Control Patients will follow the usual care program: * The Pediatric Asthma Quality of Life Questionnaire (PAQLQ); * The Children Asthma Control Test (C-ACT); * the Pediatric Caregiver Asthma Quality of Life Questionnaire (PCAQLQ); * Functional respiratory tests: forced expiratory volume in one second (FEV1), forced expiratory flow between 25% and 75% (FEF 25-75), forced vital capacity (FVC) and Peak expiratory flow (PEF) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Impact of a Short Early Therapeutic Education Program on Quality of life of asthmatic children
The main objective is to measure the impact of the program on the QOL of asthmatic primary-school aged children seen for the first time in consultation with a pediatric pulmonologist.
QOL of the children, will be assessed by Pediatric Asthma Quality of Life Questionnaire, PAQLQ.
Measured: 2 YEARS
Secondary outcomes (5)
Impact of a Short Early Therapeutic Education Program on QOL of Parents of asthmatic children
The secondary objective is to assess the effects of the program on the QOL of parents.
QOL of the accompanying parent will be assessed by the Pediatric Asthma Caregiver's Quality of Life Questionnaire (PACQLQ)
Measured: 2 YEARS
Impact of a Short Early Therapeutic Education Program on Asthma Management of asthmatic children
The secondary objective is to assess the effects of the program on asthma management.
Asthma management will be assessed by Childhood Asthma Control Test (C-ACT)
Measured: 2 YEARS
Impact of a Short Early Therapeutic Education Program on Functional respiratory test of asthmatic children
The secondary objective is to assess the effects of the program on parameters of functional respiratory tests.(FRT).
FRT will be assessed by forced expiratory volume in one second (FEV1), forced expiratory flow between 25% and 75% (FEF 25-75), the forced vital capacity (FVC) and Peak expiratory flow (PEF).
Measured: 2 YEARS
Presence of Cotinine and Nicotine from Hair and Urine analysis respectively
Measured: 2 YEARS
Levels of exposure to polycyclic aromatic hydrocarbons (PAH) through urine analysis
Measured: 2 YEARS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2015 (estimated)
- Study start1 Mar 2017
- Primary completion31 Aug 2017
- Study completion31 Aug 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 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
- NCT02636920
- Sponsor's protocol ID
- 8/2014-
- Acronym
- TEP
- Status last verified
- Dec 2020
- First submitted
- 30 Oct 2015
- Last updated
- 19 Dec 2020
- 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 19 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study and Development of Application Models of "Therapeutic Education to the Patient" (TEP) in Asthmatic Children
- ClinicalTrials.gov ID
- NCT02636920
- Acronym / sponsor ID
- TEP / 8/2014-
- Conditions
- Asthma
- Keywords
- Asthma, Children
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Stefania La Grutta, MDUniversity, hospital or other
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- 31 Aug 2017 (actual)
- Study completion
- 31 Aug 2017 (actual)
- First posted
- 22 Dec 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.
It is an interventional prospective study. The study will assess the intervention of the "Therapeutic Education to the Patient (TEP)" on the quality of life in asthmatic children.
The patients will be enrolled from the 1st of May 2016 to the 31st of December 2016 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.
Detailed description
It is an interventional prospective study. The study will assess the intervention of the "Therapeutic Education to the Patient (TEP)" on the quality of life in asthmatic children.
The patients will be enrolled from the 1st of May 2016 to the 31st of December 2016 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.
25 Case Patients will follow the Therapeutic Education to the Patient (TEP) and 25 Control Patients will follow the usual care program.
The following procedures will be performed:
- Pediatric Asthma Quality of Life Questionnaire (PAQLQ);
- Children Asthma Control Test (C-ACT);
- Pediatric Caregiver Asthma Quality of Life Questionnaire (PCAQLQ);
- Familiar Empowerment Scale (FES);
- Functional respiratory tests: forced expiratory volume in one second (FEV1), forced expiratory flow between 25% and 75% (FEF 25-75), forced vital capacity (FVC) and Peak expiratory flow (PEF); in addition, FEV1 and PEF will be daily recorded through the SmartOne device (Medical International Research s.r.l.), a portable flow peak meter for smartphones;
- Evaluation of the presence of Cotinine and Nicotine from Hair and Urine analysis respectively;
- Evaluation of levels of exposure to polycyclic aromatic hydrocarbons (PAH) through urine analysis.
Data collection about asthma control, quality of life and spirometry will be managed through DragONE, a downloadable APP for smartphones.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TEP-CASES | Other | Other: Therapeutic Education to the Patient (TEP)25 Case Patients will follow the Therapeutic Education to the Patient (TEP). In addition the following procedures will be performed: * Pediatric Asthma Quality of Life Questionnaire (PAQLQ); * Children Asthma Control Test (C-ACT); * Pediatric Caregiver Asthma Quality of Life Questionnaire (PCAQLQ); * Functional respiratory tests: forced expiratory volume in one second (FEV1), forced expiratory flow between 25% and 75% (FEF 25-75), forced vital capacity (FVC) and Peak expiratory flow (PEF) |
| TEP-CONTROLS | No intervention | –25 Control Patients will follow the usual care program: * The Pediatric Asthma Quality of Life Questionnaire (PAQLQ); * The Children Asthma Control Test (C-ACT); * the Pediatric Caregiver Asthma Quality of Life Questionnaire (PCAQLQ); * Functional respiratory tests: forced expiratory volume in one second (FEV1), forced expiratory flow between 25% and 75% (FEF 25-75), forced vital capacity (FVC) and Peak expiratory flow (PEF) |
Who may qualify
- Ages
- 6 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Diagnosis of asthma
Key exclusion criteria (4 listed)
- Acute respiratory infection signs
- Immunologic and metabolic systemic disease
- Major malformation of upper respiratory tract
- Active smokers patients
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 |
|---|---|---|
| Therapeutic Education to the Patient (TEP)Also: TEP* Educational Diagnosis, asking what patient has, what he knows, what he is doing, what he would like to do. * Therapeutic Contract, to define objectives to reach at the end of educational path, integrating new knowledges and replacing wrong cognitive-behavior models with new schemes. * Educational Therapeutic Intervention, with individual or group methodologies (Role Playing, Brain Storming) and a disease diary in which patients could describe symptoms, therapies, behaviors and benefits. * Assessing of the knowledges acquired by patients. | Other | TEP-CASES |
Primary outcome
Impact of a Short Early Therapeutic Education Program on Quality of life of asthmatic children
Time frame: 2 YEARS
The main objective is to measure the impact of the program on the QOL of asthmatic primary-school aged children seen for the first time in consultation with a pediatric pulmonologist. QOL of the children, will be assessed by Pediatric Asthma Quality of Life Questionnaire, PAQLQ.
5 secondary outcomes
Impact of a Short Early Therapeutic Education Program on QOL of Parents of asthmatic children
Time frame: 2 YEARS
Impact of a Short Early Therapeutic Education Program on Asthma Management of asthmatic children
Time frame: 2 YEARS
Impact of a Short Early Therapeutic Education Program on Functional respiratory test of asthmatic children
Time frame: 2 YEARS
Presence of Cotinine and Nicotine from Hair and Urine analysis respectively
Time frame: 2 YEARS
Levels of exposure to polycyclic aromatic hydrocarbons (PAH) through urine analysis
Time frame: 2 YEARS
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 19 Dec 2020.
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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?
A study testing Therapeutic Education to the Patient (TEP) in people with 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 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 19 Dec 2020. 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?
Impact of a Short Early Therapeutic Education Program on Quality of life of asthmatic children (time frame: 2 YEARS). 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 19 Dec 2020.