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Telephone Coaches to Improve Control of Asthma in Children ( PARTNER) Study) (PARTNER)

2018年10月1日 更新者:Jane Garbutt, MD、Washington University School of Medicine

Parents, Pediatricians, and Telephone Coaches Partner to Improve Control of Asthma

Parents of children with asthma must work with their child's pediatrician to ensure that their child's asthma is managed well. Asthma coaches are one way to facilitate and support the relationship between parents and pediatricians. This study will evaluate whether access to a 12-month telephone asthma coaching program for parents is an effective way to improve asthma outcomes in children.

調査の概要

詳細な説明

Asthma is the most common long-term disease among children. Each year, most children with asthma will have at least one asthma exacerbation, experience asthma symptoms on approximately 100 days, and miss 4 days of school because of asthma. Surveys of primary care physicians (PCPs) and asthma patients have indicated that asthma care is episodic, effective asthma controller medications are underused, and few PCPs provide self-management education or support for parents of children with asthma. Previous research showed that when an asthma coach worked with parents of children from low-income, urban neighborhoods, there were multiple benefits: improved self-management behaviors, reduced asthma hospitalizations, and improved rates of follow-up with a PCP after an emergency department visit for asthma symptoms. In this study, researchers will evaluate the effectiveness of an asthma coach program in a larger, general asthma population. Trained asthma coaches will work with parents of children with asthma to provide education about the goals of asthma care, and they will encourage and facilitate an active partnership between the family and PCP to enhance asthma care and improve self-management behaviors. Study researchers will then evaluate the effectiveness of this program at improving asthma control and quality of life among children with asthma. The cost effectiveness of the program will also be analyzed.

This study will enroll pediatricians and parents of children between 5 and 12 years old who have persistent asthma. Pediatricians will be randomly assigned to either the asthma coach program or usual care. All pediatricians will receive access to the Education in Quality Improvement for Pediatric Practice (eQIPP) module for asthma care provided by the American Academy of Pediatrics. They will also receive articles about effective doctor-parent communication on asthma and asthma billing practices. In addition, pediatricians taking part in the asthma coach program will attend two meetings to learn about asthma coaching and how the program can be implemented into their practice. For 12 months, an asthma coach will work directly with the parents of children who see doctors participating in the asthma coaching group. Telephone calls with the asthma coach will be arranged at times convenient for the parent and will occur anywhere between once a week to once a month. At Months 12 and 24, about 40 parents of children in each pediatrician's practice will participate in telephone interviews and their children's medical charts will be reviewed to assess asthma control, asthma-related quality of life factors, and urgent care events.

研究の種類

介入

入学 (実際)

984

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

    • Missouri
      • Saint Louis、Missouri、アメリカ、63110
        • Washington University School of Medicine

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

3年~12年 (子)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

説明

Inclusion Criteria for Pediatricians:

  • Affiliated with St. Louis Children's Hospital and/or Washington University in St. Louis
  • Provides asthma care for at least 40 asthmatic children from the target population

Inclusion Criteria for Parents:

  • Has a child who is between 3 and 12 years old with persistent asthma and who is cared for by a study pediatrician

Exclusion Criteria for Pediatricians:

  • Spends less than 50% of their time in general pediatrics
  • Is an asthma specialist (allergist or pulmonary specialist)
  • Another physician in their practice is participating in the study

Exclusion Criteria for Parents:

  • Their asthmatic child is less than 3 years old or is 13 years or older at the time of study entry
  • Their child has not had a physician diagnosis of asthma before study entry
  • Their child has a significant comorbid condition
  • Cannot speak English
  • Does not have a phone

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

  • 主な目的:処理
  • 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:1
Pediatricians and parents of children with asthma will participate in the asthma coaching program.
Parents will have access to an asthma coach for 12 months. Telephone calls between parents and coaches will occur anywhere from once a week to once a month.
アクティブコンパレータ:2
Children of parents enrolled in the study will receive usual asthma care from their pediatrician.
Children of parents enrolled in the study will receive the normal asthma care that their pediatricians usually provide.

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
時間枠
Asthma control
時間枠:Measured at Months 12 and 24
Measured at Months 12 and 24
Asthma-related quality of life
時間枠:Measured at Months 12 and 24
Measured at Months 12 and 24
Urgent care events
時間枠:Measured at Months 12 and 24
Measured at Months 12 and 24

二次結果の測定

結果測定
時間枠
Adherence to guideline-recommended asthma maintenance care behaviors
時間枠:Measured at Months 12 and 24
Measured at Months 12 and 24
Cost effectiveness
時間枠:Measured at Months 12 and 24
Measured at Months 12 and 24

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。

捜査官

  • 主任研究者:Robert Strunk, MD、Washington University School of Medicine
  • 主任研究者:Jane M. Garbutt, MB, ChB、Washington University School of Medicine

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

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 (実際)

2008年8月1日

一次修了 (実際)

2013年5月3日

研究の完了 (実際)

2014年5月3日

試験登録日

最初に提出

2009年3月10日

QC基準を満たした最初の提出物

2009年3月10日

最初の投稿 (見積もり)

2009年3月12日

学習記録の更新

投稿された最後の更新 (実際)

2018年10月3日

QC基準を満たした最後の更新が送信されました

2018年10月1日

最終確認日

2018年10月1日

詳しくは

本研究に関する用語

その他の研究ID番号

  • 634
  • R01HL072919 (米国 NIH グラント/契約)
  • R01HL072919-06 (米国 NIH グラント/契約)

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。

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