Telephone Coaches to Improve Control of Asthma in Children ( PARTNER) Study) (PARTNER)
Primary Purpose
Asthma
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Asthma Coaching Program
Usual Care
Sponsored by
About this trial
This is an interventional treatment trial for Asthma focused on measuring Consumer Participation, Telephone Coaching Program
Eligibility 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
Sites / Locations
- Washington University School of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
1
2
Arm Description
Pediatricians and parents of children with asthma will participate in the asthma coaching program.
Children of parents enrolled in the study will receive usual asthma care from their pediatrician.
Outcomes
Primary Outcome Measures
Asthma control
Asthma-related quality of life
Urgent care events
Secondary Outcome Measures
Adherence to guideline-recommended asthma maintenance care behaviors
Cost effectiveness
Full Information
NCT ID
NCT00860834
First Posted
March 10, 2009
Last Updated
October 1, 2018
Sponsor
Washington University School of Medicine
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
1. Study Identification
Unique Protocol Identification Number
NCT00860834
Brief Title
Telephone Coaches to Improve Control of Asthma in Children ( PARTNER) Study)
Acronym
PARTNER
Official Title
Parents, Pediatricians, and Telephone Coaches Partner to Improve Control of Asthma
Study Type
Interventional
2. Study Status
Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
August 2008 (Actual)
Primary Completion Date
May 3, 2013 (Actual)
Study Completion Date
May 3, 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Washington University School of Medicine
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
Consumer Participation, Telephone Coaching Program
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
984 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Pediatricians and parents of children with asthma will participate in the asthma coaching program.
Arm Title
2
Arm Type
Active Comparator
Arm Description
Children of parents enrolled in the study will receive usual asthma care from their pediatrician.
Intervention Type
Behavioral
Intervention Name(s)
Asthma Coaching Program
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Usual Care
Intervention Description
Children of parents enrolled in the study will receive the normal asthma care that their pediatricians usually provide.
Primary Outcome Measure Information:
Title
Asthma control
Time Frame
Measured at Months 12 and 24
Title
Asthma-related quality of life
Time Frame
Measured at Months 12 and 24
Title
Urgent care events
Time Frame
Measured at Months 12 and 24
Secondary Outcome Measure Information:
Title
Adherence to guideline-recommended asthma maintenance care behaviors
Time Frame
Measured at Months 12 and 24
Title
Cost effectiveness
Time Frame
Measured at Months 12 and 24
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jane M. Garbutt, MB, ChB
Organizational Affiliation
Washington University School of Medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Robert Strunk, MD
Organizational Affiliation
Washington University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
22469168
Citation
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.
Results Reference
background
PubMed Identifier
25445827
Citation
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.
Results Reference
derived
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Telephone Coaches to Improve Control of Asthma in Children ( PARTNER) Study)
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