Study and Development of Application Models of "Therapeutic Education to the Patient" (TEP) in Asthmatic Children (TEP)
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.
調査の概要
詳細な説明
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.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
-
-
Sicily
-
Palermo、Sicily、イタリア、90146
- Institute of Biomedicine and Molecular Immunology (IBIM), National Research Council
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Diagnosis of asthma
Exclusion Criteria:
- Acute respiratory infection signs
- Immunologic and metabolic systemic disease
- Major malformation of upper respiratory tract
- Active smokers patients
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：他の
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
他の：TEP-CASES
25 Case Patients will follow the Therapeutic Education to the Patient (TEP). In addition the following procedures will be performed:
|
他の名前：
|
|
介入なし：TEP-CONTROLS
25 Control Patients will follow the usual care program:
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Impact of a Short Early Therapeutic Education Program on Quality of life of asthmatic children
時間枠：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. |
2 YEARS
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Impact of a Short Early Therapeutic Education Program on QOL of Parents of asthmatic children
時間枠：2 YEARS
|
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) |
2 YEARS
|
|
Impact of a Short Early Therapeutic Education Program on Asthma Management of asthmatic children
時間枠：2 YEARS
|
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) |
2 YEARS
|
|
Impact of a Short Early Therapeutic Education Program on Functional respiratory test of asthmatic children
時間枠：2 YEARS
|
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). |
2 YEARS
|
|
Presence of Cotinine and Nicotine from Hair and Urine analysis respectively
時間枠：2 YEARS
|
2 YEARS
|
|
|
Levels of exposure to polycyclic aromatic hydrocarbons (PAH) through urine analysis
時間枠：2 YEARS
|
2 YEARS
|
協力者と研究者
スポンサー
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。