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

1 oktober 2018 uppdaterad av: 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.

Studieöversikt

Status

Avslutad

Betingelser

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Faktisk)

984

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

    • Missouri
      • Saint Louis, Missouri, Förenta staterna, 63110
        • Washington University School of Medicine

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

3 år till 12 år (Barn)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Enda

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: 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.
Aktiv komparator: 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.

Vad mäter studien?

Primära resultatmått

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

Sekundära resultatmått

Resultatmått
Tidsram
Adherence to guideline-recommended asthma maintenance care behaviors
Tidsram: Measured at Months 12 and 24
Measured at Months 12 and 24
Cost effectiveness
Tidsram: Measured at Months 12 and 24
Measured at Months 12 and 24

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Utredare

  • Huvudutredare: Robert Strunk, MD, Washington University School of Medicine
  • Huvudutredare: Jane M. Garbutt, MB, ChB, Washington University School of Medicine

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

1 augusti 2008

Primärt slutförande (Faktisk)

3 maj 2013

Avslutad studie (Faktisk)

3 maj 2014

Studieregistreringsdatum

Först inskickad

10 mars 2009

Först inskickad som uppfyllde QC-kriterierna

10 mars 2009

Första postat (Uppskatta)

12 mars 2009

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

3 oktober 2018

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

1 oktober 2018

Senast verifierad

1 oktober 2018

Mer information

Termer relaterade till denna studie

Andra studie-ID-nummer

  • 634
  • R01HL072919 (U.S.S. NIH-anslag/kontrakt)
  • R01HL072919-06 (U.S.S. NIH-anslag/kontrakt)

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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