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Using the Telephone to Improve Care in Childhood Asthma

Asthma is the most common chronic disease of childhood and a major cause of morbidity in the United States. If asthma symptoms are controlled, a child with asthma can stay well and lead a normal life. Daily use of inhaled steroids controls symptoms and reduces morbidity and emergent health care utilization in children with persistent asthma, and is safe for long-term use. However, inhaled steroids are underused in community asthma care.

The Telephone Asthma Program (TAP) is a series of brief, telephone calls with a trained coach to help the parent manage the child's asthma care. The coach will teach self-management skills, help the parent to use the child's asthma medicines effectively, provide support and remind the parent to go for follow-up care with the pediatrician. We hypothesized that the Telephone Asthma Program will reduce the incidence of acute exacerbations of asthma that require emergent care, improve the quality of life of children with asthma and their parents, and increase the daily use of inhaled steroids in children with persistent asthma. We evaluated the Telephone Asthma Program in a randomized controlled trial involving 362 children aged 5 to 12 years old cared for by community pediatricians. Eligible children were randomized to the TAP program or usual care by their pediatrician.

調査の概要

状態

完了

条件

詳細な説明

Asthma morbidity is largely preventable with effective maintenance care. National guidelines recommend 1) daily treatment with inhaled corticosteroids (ICS) to prevent asthma symptoms and activity limitations, minimize acute exacerbations and maintain normal lung function; 2) early intervention guided by a written Asthma Action Plan for worsening symptoms;3) a partnership between the primary care provider, the patient and their family to develop shared treatment goals, select an appropriate treatment plan, resolve asthma-related concerns, and provide support for day-to-day care, and 4) periodic assessments (every 1 to 6 months) by the physician to monitor asthma control and assess if the goals of therapy are being met, with asthma self-management education provided at diagnosis and reinforced at every opportunity. Despite widespread dissemination of these guidelines, under-use of controller medications is pervasive, home management of an acute exacerbation is often delayed and inadequate, and only 50% of asthmatic children report maintenance care visits twice a year. Most primary care pediatricians do not provide education about use of preventive treatments or self-management behaviors citing lack of confidence in their ability to effect change, logistical issues such as lack of time, educational materials, support staff, and inadequate reimbursement as significant barriers to these activities. Practical, efficient interventions to improve maintenance asthma care in office-practice are needed.

In response to complaints from community pediatricians in our practice-based research network that few children with persistent asthma used their controller medications as prescribed we collaborated with local asthma experts and the telephone triage service at our children's hospital to develop and evaluate a 12-month telephone-coaching program to provide education and support to parents to improve asthma self-management for their children. The Telephone Asthma Program (TAP) was provided in addition to usual care, and was evaluated in a randomized controlled trial (RCT).

The TAP program was based on the Transtheoretical Model of Behavior Change developed by James Prochaska. This model postulates a series of 5 ordered stages of readiness to change to a desired behavior (Precontemplation, Contemplation, Preparation, Action and Maintenance). The desired behaviors for TAP were: 1) using controller medications as prescribed, 2) administering rescue medications at the child's first signs of an asthma exacerbation, 3) having an up-to-date asthma action plan readily available for all who may need it, and 4) having a collaborative relationship with the child's PCP that included regular asthma check-up visits at least every 6 months. Our goal was that all 4 behaviors would be addressed by the coach for each parent throughout the 12-month program period. Guided by computerized telephone protocols the coach provided tailored care advice appropriate for the parent's stage of readiness for behavior change. In this way, the coach could provide education and support to help the parent to provide effective asthma care at home for their child, and supplement the care provided by the physician.

研究の種類

介入

入学 (実際)

362

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
      • St 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

5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:

  • Physician diagnosis of asthma for at least a year
  • At least one acute exacerbation of asthma in past 12 months that required a visit to the emergency department, hospitalization or an unscheduled office visit for acute care and/or a course of oral steroids.
  • Taking daily controller medications or symptoms consistent with persistent asthma

Exclusion Criteria:

  • No phone
  • Unable to speak English
  • Child has another disease that requires regular monitoring by pediatrician
  • A sibling is already enrolled in the study
  • Child's primary asthma provider is an asthma specialist

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:支持療法
  • 割り当て:ランダム化
  • 介入モデル:並列代入
  • マスキング:トリプル

武器と介入

参加者グループ / アーム
介入・治療
介入なし:Control
Families assigned to the control arm will receive usual asthma care from the child's primary care provider.
実験的:Intervention
The Telephone Asthma Program and usual care.

The parent will have access to a trained asthma coach for 12 months. The coach will call the parents at mutually convenient times (up to 12 times a year) to work on 4 targeted asthma behaviors:

  1. Using asthma controller medications as prescribed
  2. Having and Asthma Action Plan available to all who may need it.
  3. Using asthma rescue medications with the child's first symptoms.
  4. Having a collaborative relationship with the child's primary care provider that includes asthma check-ups at least twice a year.

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
Parental asthma-related quality of life
時間枠:one year
one year
Urgent care events for asthma
時間枠:One year
One year

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:Jane Garbutt, MD、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

2004年1月1日

一次修了 (実際)

2006年1月1日

研究の完了 (実際)

2007年6月1日

試験登録日

最初に提出

2008年4月15日

QC基準を満たした最初の提出物

2008年4月15日

最初の投稿 (見積もり)

2008年4月17日

学習記録の更新

投稿された最後の更新 (見積もり)

2008年4月17日

QC基準を満たした最後の更新が送信されました

2008年4月15日

最終確認日

2008年4月1日

詳しくは

本研究に関する用語

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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