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

1. oktober 2018 oppdatert 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.

Studieoversikt

Status

Fullført

Forhold

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Faktiske)

984

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
      • Saint 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

3 år til 12 år (Barn)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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

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

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Enkelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.

Hva måler studien?

Primære resultatmål

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

Sekundære resultatmål

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

Samarbeidspartnere og etterforskere

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

Etterforskere

  • Hovedetterforsker: Robert Strunk, MD, Washington University School of Medicine
  • Hovedetterforsker: Jane M. Garbutt, MB, ChB, 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 (Faktiske)

1. august 2008

Primær fullføring (Faktiske)

3. mai 2013

Studiet fullført (Faktiske)

3. mai 2014

Datoer for studieregistrering

Først innsendt

10. mars 2009

Først innsendt som oppfylte QC-kriteriene

10. mars 2009

Først lagt ut (Anslag)

12. mars 2009

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

3. oktober 2018

Siste oppdatering sendt inn som oppfylte QC-kriteriene

1. oktober 2018

Sist bekreftet

1. oktober 2018

Mer informasjon

Begreper knyttet til denne studien

Andre studie-ID-numre

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

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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