Parents, Pediatricians, and Asthma Telephone Coaches Partner to Improve Control of Asthma in Children (The PARTNER Study)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Jane Garbutt, MD, Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT00860834
First received: March 10, 2009
Last updated: March 28, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention
Asthma
Behavioral: Asthma Coaching Program
Behavioral: Usual Care

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Parents, Pediatricians, and Telephone Coaches Partner to Improve Control of Asthma

Resource links provided by NLM:


Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:
  • Asthma control [ Time Frame: Measured at Months 12 and 24 ] [ Designated as safety issue: No ]
  • Asthma-related quality of life [ Time Frame: Measured at Months 12 and 24 ] [ Designated as safety issue: No ]
  • Urgent care events [ Time Frame: Measured at Months 12 and 24 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Adherence to guideline-recommended asthma maintenance care behaviors [ Time Frame: Measured at Months 12 and 24 ] [ Designated as safety issue: No ]
  • Cost effectiveness [ Time Frame: Measured at Months 12 and 24 ] [ Designated as safety issue: No ]

Estimated Enrollment: 1000
Study Start Date: August 2008
Estimated Study Completion Date: May 2014
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Pediatricians and parents of children with asthma will participate in the asthma coaching program.
Behavioral: 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.
Active Comparator: 2
Children of parents enrolled in the study will receive usual asthma care from their pediatrician.
Behavioral: Usual Care
Children of parents enrolled in the study will receive the normal asthma care that their pediatricians usually provide.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   3 Years to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00860834

Locations
United States, Missouri
Washington University School of Medicine
St. Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
Investigators
Principal Investigator: Jane M. Garbutt, MB, ChB Washington University School of Medicine
Principal Investigator: Robert Strunk, MD Washington University School of Medicine
  More Information

Publications:
Responsible Party: Jane Garbutt, MD, Associate Professor, Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT00860834     History of Changes
Other Study ID Numbers: 634, R01HL072919, R01 HL072919
Study First Received: March 10, 2009
Last Updated: March 28, 2014
Health Authority: United States: Federal Government

Keywords provided by Washington University School of Medicine:
Consumer Participation
Telephone Coaching Program

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on October 19, 2014