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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.

Studieoversikt

Status

Fullført

Forhold

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Faktiske)

362

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

    • Missouri
      • St Louis, Missouri, Forente stater, 63110
        • Washington University School of Medicine

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

5 år til 12 år (Barn)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Støttende omsorg
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Trippel

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Ingen inngripen: Control
Families assigned to the control arm will receive usual asthma care from the child's primary care provider.
Eksperimentell: 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tidsramme
Parental asthma-related quality of life
Tidsramme: one year
one year
Urgent care events for asthma
Tidsramme: One year
One year

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Etterforskere

  • Hovedetterforsker: Jane Garbutt, MD, Washington University School of Medicine

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. januar 2004

Primær fullføring (Faktiske)

1. januar 2006

Studiet fullført (Faktiske)

1. juni 2007

Datoer for studieregistrering

Først innsendt

15. april 2008

Først innsendt som oppfylte QC-kriteriene

15. april 2008

Først lagt ut (Anslag)

17. april 2008

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

17. april 2008

Siste oppdatering sendt inn som oppfylte QC-kriteriene

15. april 2008

Sist bekreftet

1. april 2008

Mer informasjon

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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