Asthma in Central Texas Project
2015年4月2日 更新者：University of Texas at Austin
Enhancing Children's and Parents' Asthma Management
Asthma is the most common chronic childhood illness and disproportionately affects children who are ethnic minorities and poor.
Few studies of childhood asthma have been conducted with children who live in rural areas or have included Mexican American children in their samples.
This study builds on the original R01NR007770 with findings that demonstrated the intervention could improve children's asthma self-management, asthma knowledge, metered dose inhaler skill, asthma severity, and parents' asthma management and access to care.
In this competing continuation, the investigators added a third arm to the current research design with schools randomized into either an in-school asthma intervention, an in-school attention-control intervention, or an alternate intervention-delivery format of a single 5.5-hour asthma day camp.
The tri-ethnic sample will be composed of 320 Mexican-American, African-American, and White rural school-aged children (grades 2-5) who have asthma and their parents.
In addition, the investigators propose adding a non-invasive measure of chronic airway inflammation (exhaled nitric oxide) to assess the impact of changes in asthma management on airway inflammation.
Families will be followed for a full year with data collection at baseline and at 1-month, 4-months, and 7-months after the intervention to assess improvement in children's asthma morbidity, asthma severity, airway inflammation, family asthma management and quality of life.
Hypotheses (H): Children in the Camp-Workshop group and the School-Home group will demonstrate equivalent improvements, but greater improvements than the Attention-Control group in:(H1.1)
their asthma severity and airway inflammation from the Time 1 assessment when compared to Time 4 assessment; (H1.2) office visits, ED visits, and hospitalizations for asthma, and absenteeism for the study year (Time 4) when compared to the pre-study year (Time 1); and (H1.4) Parents in the intervention arms will demonstrate sustained improvements in asthma caregiver's quality of life (QOL0 from the pre-study year (Time 1) to the end of the study year (Time 4) measurement, when compared to the Attention-Control group.
調査の概要
詳細な説明
Families are recruited at the beginning of the school year (Time 1, October-November); parents consent and child assent obtained and baseline data collected in fall.
The intervention is provided in December-January.
Follow-up data are collected at February (Time 2), April (Time 3), and August (Time 4).
研究の種類
介入
入学 (実際)
292
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
-
-
Texas
-
Austin、Texas、アメリカ、78712
- The University of Texas at Austin
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
6年～13年 (子)
健康ボランティアの受け入れ
はい
受講資格のある性別
全て
説明
Inclusion Criteria:
- parent reports the child has a diagnosis of asthma made by a medical provider;
- has had asthma symptoms in the previous 12 months;
- speaks either English or Spanish.
Exclusion Criteria:
- has a significant co-morbidity that would preclude participation in classes (e.g., severe cerebral palsy, oxygen dependent conditions)
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Asthma in-school class
Provided in 16 15-minute sessions (4 hours total didactic time); scheduled 3 sessions/week.
The content is provided by trained asthma educators.
The Asthma Plan for Kids (AP-K) is a 7-step curriculum for children to use when responding to asthma symptoms.
Skills practice with placebo metered dose inhaler (MDI) and peak expiratory flow (PEF) meters with PEF score interpretation.
Topics include (a) identifying lung function, asthma warning signs, symptoms, and triggers; (b) learning skills to manage symptoms, including PEF meter score interpretation, communication with adults (e.g.
teachers, coaches, family members), medication use and MDI technique; (c) evaluating asthma symptoms and the effectiveness of management; and (d) discussing how to stay active in a safe manner.
|
他の名前：
|
|
実験的：Asthma Day Camp
The asthma day camp is provided in a single day session (5.5 hours total) by trained camp staff.
The same skills (i.e., placebo metered dose inhaler (MDI) and peak expiratory flow (PEF) meters) and topics [a) identifying lung function, asthma warning signs, symptoms, and triggers; (b) learning skills to manage symptoms, including PEF meter score interpretation, communication with adults (e.g.
teachers, coaches, family members), medication use and MDI technique; (c) evaluating asthma symptoms and the effectiveness of management; and (d) discussing how to stay active in a safe manner] are covered as those in the asthma in-school classes.
|
|
|
偽コンパレータ：Health Promotion in-school class
The mock comparison follows the in-school format of 16 15-minute sessions; scheduled 3 sessions/week.
The content is provided by trained health educators and includes skills practice (i.e., handwashing and brushing teeth) and health promotion topics of nutrition, healthy snacks, preventing colds, and safe exercise.
|
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 |
|---|---|---|
|
Absenteeism, End of Study
時間枠：12 months
|
(Days absent/days enrolled)x100 = absenteeism.
Using data provided by the school district at the end of the study year.
|
12 months
|
|
Quality of Life, End of Study
時間枠：12 months
|
Self reported asthma-related quality of life.
Outcome data were collected at end of study (Time 4).
The Pediatric Asthma Quality of Life scale.
Minimum score 23 to maximum score of 115.
A higher score indicates worse quality of life.
Mean scale scores are computed.
|
12 months
|
|
Number of Days Hospitalized, During Study Year
時間枠：12 months
|
Number of days hospitalized for asthma.
Data were obtained from parent report at the second, third, and fourth data collection point.
The number of hospitalization days were summed for a total number at the end of the 12 months.
|
12 months
|
|
Emergency Department Visits, Study Year
時間枠：12 months
|
Number of visits to Emergency Department for asthma.
Data is obtained from parents at three time points (time 2, 3, and 4) and summed for total number of visits to the emergency department for asthma during the study year.
|
12 months
|
|
Number of Asthma Hospitalizations Pre-Study Year
時間枠：12 months before baseline
|
Number of times hospitalized for asthma.
Data is obtained from parents for the pre-study year for the previous 12 months.
|
12 months before baseline
|
|
Absenteeism Pre-study Year
時間枠：12 months before baseline
|
(Days absent/days enrolled)x100 = absenteeism.
Using data for the 12 months prior to study enrollment as the pre-study year.
Data is provided by the participating school districts.
|
12 months before baseline
|
|
Number of Days in Hospital for Asthma, Pre-Study Year
時間枠：12 months before baseline
|
Number of days hospitalized for asthma.
Data is obtained from parents for the pre-study year for the previous 12 months.
|
12 months before baseline
|
|
Number of Asthma Hospital Stays, During Study Year
時間枠：12 months
|
Number of hospital admissions for asthma.
Data were obtained from parent report at the second, third, and fourth data collection point.
The number of hospitalizations were summed for a total number at the end of the 12 months.
|
12 months
|
|
Emergency Department Visits, Pre-study Year
時間枠：12 months before baseline
|
Number of visits to Emergency Department for asthma.
Data is obtained from parents for the pre-study year for the previous 12 months.
|
12 months before baseline
|
|
Quality of Life, Pre-study Year
時間枠：12 months before baseline
|
Self reported asthma-related quality of life.
Data were collected at study enrollment (time 1).
The Pediatric Asthma Quality of Life scale.
Minimum score 23 to maximum score of 115.
A higher score indicates worse quality of life.
Mean scale scores are computed.
|
12 months before baseline
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Asthma Self-management, Time 4
時間枠：Time 4, at 12 months
|
Child self-report of asthma preventive and management activities, collected at each of 4 time points.
This is the Time 4, final measure.
Asthma Inventory for Children, 18-item scale, response scale 1-5, minimum score = 18, maximum score = 65, higher score = more frequent asthma self management behaviors.
|
Time 4, at 12 months
|
|
Home Asthma Management, Time 4, End of Study
時間枠：Time 4 at 12 months
|
Parent report of asthma preventive and treatment activities.
Data collected at final study visit, Time 4. Home Asthma Management scale, asthma preventive and asthma treatment behaviors performed by parent, response scale 1-5, scale range 16-70, higher scores = more frequent home asthma management behaviors.
|
Time 4 at 12 months
|
|
Metered Dose Inhaler Skill, Time 4
時間枠：Time 4 at 12 months
|
Observation score of child's skill in using a placebo metered dose inhaler (a teaching inhaler).
Observation data recorded by trained data collectors.
8-item scale listing the steps to perform proper inhalation technique.
Number of correct steps are summed.
Higher score = better skill in using inhaler.
Collected at final, time 4 data visit.
|
Time 4 at 12 months
|
|
Medication Adherence, Time 4
時間枠：Time 4 at 12 months
|
Parent report of their child remembering/forgetting to take medications.
4-item scale (forgot to take medicine, was careless in taking medicine, stopped taking medicine due to feeling better, stopped taking medicine due to feeling worse), dichotomous response scale (yes, no), sum of number of yes items.
Range 0-4, higher score means worse adherence.
Data are collected at final data point, Time 4.
|
Time 4 at 12 months
|
|
Asthma Self-management, Time 3
時間枠：Time 3 at 9 months
|
Child self-report of asthma preventive and management activities, collected at each of 4 time points.
This is the Time 3 measure.
Asthma Inventory for Children, 18-item scale, response scale 1-5, minimum score = 18, maximum score = 65, higher score = more frequent asthma self management behaviors.
|
Time 3 at 9 months
|
|
Asthma Self-management, Time 2
時間枠：Time 2 at 5 months
|
Child self-report of asthma preventive and management activities, collected at each of 4 time points.
This is the Time 2 measure.
Asthma Inventory for Children, 18-item scale, response scale 1-5, minimum score = 18, maximum score = 65, higher score = more frequent asthma self management behaviors.
|
Time 2 at 5 months
|
|
Asthma Self-management, Time 1, Baseline
時間枠：Time 1, baseline
|
Child self-report of asthma preventive and management activities, collected at each of 4 time points.
This is the baseline, Time 1 measure.
Asthma Inventory for Children, 18-item scale, response scale 1-5, minimum score = 18, maximum score = 65, higher score = more frequent asthma self management behaviors.
|
Time 1, baseline
|
|
Home Asthma Management, Time 1, Baseline
時間枠：Time 1, baseline
|
Parent report of asthma preventive and treatment activities.
Data are collected at study enrollment, Time 1, baseline visit.
Home Asthma Management scale, asthma preventive and asthma treatment behaviors performed by parent, response scale 1-5, scale range 16-70, higher scores = more frequent home asthma management behaviors.
|
Time 1, baseline
|
|
Home Asthma Management, Time 2.
時間枠：Time 2 at 5 months
|
Parent report of asthma preventive and treatment activities.
Data collected at the time 2 visit.
Home Asthma Management scale, asthma preventive and asthma treatment behaviors performed by parent, response scale 1-5, scale range 16-70, higher scores = more frequent home asthma management behaviors.
|
Time 2 at 5 months
|
|
Home Asthma Management, Time 3
時間枠：Time 3 at 9 months
|
Parent report of asthma preventive and treatment activities.
Data collected at third time point (Time 3).
Home Asthma Management scale, asthma preventive and asthma treatment behaviors performed by parent, response scale 1-5, scale range 16-70, higher scores = more frequent home asthma management behaviors.
|
Time 3 at 9 months
|
|
Metered Dose Inhaler Skill, Time 3
時間枠：Time 3 at 9 months
|
Observation score of child's skill in using a placebo metered dose inhaler (a teaching inhaler).
Observation data recorded by trained data collectors.
8-item scale listing the steps to perform proper inhalation technique.
Number of correct steps are summed.
Higher score = better skill in using inhaler.
Collected at time 3 data visit.
|
Time 3 at 9 months
|
|
Metered Dose Inhaler Skill, Time 2
時間枠：Time 2 at 5 months
|
Observation score of child's skill in using a placebo metered dose inhaler (a teaching inhaler).
Observation data recorded by trained data collectors.
8-item scale listing the steps to perform proper inhalation technique.
Number of correct steps are summed.
Higher score = better skill in using inhaler.
Collected at final, time 2 data visit.
|
Time 2 at 5 months
|
|
Metered Dose Inhaler Skill, Time 1
時間枠：Time 1 at baseline
|
Observation score of child's skill in using a placebo metered dose inhaler (a teaching inhaler).
Observation data recorded by trained data collectors.
8-item scale listing the steps to perform proper inhalation technique.
Number of correct steps are summed.
Higher score = better skill in using inhaler.
Collected at enrollment visit, Time 1 data visit.
|
Time 1 at baseline
|
|
Medication Adherence, Time 1
時間枠：Time 1 at baseline
|
Parent report of their child remembering/forgetting to take medications.
4-item scale (forgot to take medicine, was careless in taking medicine, stopped taking medicine due to feeling better, stopped taking medicine due to feeling worse), dichotomous response scale (yes, no), sum of number of yes items.
Range 0-4, higher score means worse adherence.
Data are collected at study enrollment, Time 1.
|
Time 1 at baseline
|
|
Medication Adherence, Time 2
時間枠：Time 2 at 5 months
|
Parent report of their child remembering/forgetting to take medications.
4-item scale (forgot to take medicine, was careless in taking medicine, stopped taking medicine due to feeling better, stopped taking medicine due to feeling worse), dichotomous response scale (yes, no), sum of number of yes items.
Range 0-4, higher score means worse adherence.
Data are collected at Time 2 visit.
|
Time 2 at 5 months
|
|
Medication Adherence, Time 3
時間枠：Time 3 at 9 months
|
Parent report of their child remembering/forgetting to take medications.
4-item scale (forgot to take medicine, was careless in taking medicine, stopped taking medicine due to feeling better, stopped taking medicine due to feeling worse), dichotomous response scale (yes, no), sum of number of yes items.
Range 0-4, higher score means worse adherence.
Data are collected at Time 3 visit.
|
Time 3 at 9 months
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Lung Inflammation, Time 4
時間枠：Time 4 at 12 months
|
Exhaled breath condensation collected and sent for lab analysis of NO3.
Data collected at Time 4 visit.
Higher values represent greater airway inflammation.
|
Time 4 at 12 months
|
|
Lung Inflammation, Time 1
時間枠：Time 1 at baseline
|
Exhaled breath condensation collected and sent for lab analysis of NO3.
Data collected at Time 1 visit.
Higher values represent greater airway inflammation.
|
Time 1 at baseline
|
|
Lung Inflammation, Time 2
時間枠：Time 2 at 5 months
|
Exhaled breath condensation collected and sent for lab analysis of NO3.
Data collected at Time 2 visit.
Higher values represent greater airway inflammation.
|
Time 2 at 5 months
|
|
Lung Inflammation, Time 3
時間枠：Time 3 at 9 months
|
Exhaled breath condensation collected and sent for lab analysis of NO3.
Data collected at Time 3 visit.
Higher values represent greater airway inflammation.
|
Time 3 at 9 months
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始
2008年12月1日
一次修了 (実際)
2013年9月1日
研究の完了 (実際)
2014年11月1日
試験登録日
最初に提出
2012年8月24日
QC基準を満たした最初の提出物
2012年8月30日
最初の投稿 (見積もり)
2012年8月31日
学習記録の更新
投稿された最後の更新 (見積もり)
2015年4月24日
QC基準を満たした最後の更新が送信されました
2015年4月2日
最終確認日
2015年4月1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。