- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00860834
Telephone Coaches to Improve Control of Asthma in Children ( PARTNER) Study) (PARTNER)
Parents, Pediatricians, and Telephone Coaches Partner to Improve Control of Asthma
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret 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.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
Missouri
-
Saint Louis, Missouri, Forenede Stater, 63110
- Washington University School of Medicine
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
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
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: 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.
|
Hvad måler undersøgelsen?
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
|
Samarbejdspartnere og efterforskere
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Robert Strunk, MD, Washington University School of Medicine
- Ledende efterforsker: Jane M. Garbutt, MB, ChB, Washington University School of Medicine
Publikationer og nyttige links
Generelle publikationer
- Garbutt JM, Highstein G, Yan Y, Strunk RC. Partner randomized controlled trial: study protocol and coaching intervention. BMC Pediatr. 2012 Apr 2;12:42. doi: 10.1186/1471-2431-12-42.
- Garbutt JM, Yan Y, Highstein G, Strunk RC. A cluster-randomized trial shows telephone peer coaching for parents reduces children's asthma morbidity. J Allergy Clin Immunol. 2015 May;135(5):1163-70.e1-2. doi: 10.1016/j.jaci.2014.09.033. Epub 2014 Oct 30.
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 634
- R01HL072919 (U.S. NIH-bevilling/kontrakt)
- R01HL072919-06 (U.S. NIH-bevilling/kontrakt)
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