AsthmaPARTNERNCT00860834
Telephone Coaches to Improve Control of Asthma in Children ( PARTNER) Study)
A study testing Asthma Coaching Program in people with Asthma, run by Washington University School of Medicine at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 12 years
- Conditions the study is for
- Asthma
- What is being tested?
- Asthma Coaching Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 984 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2008to 3 May 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
- Has a child who is between 3 and 12 years old with persistent asthma and who is cared for by a study pediatrician
Who cannot join
- 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
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
Official title: 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.
Read the 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.
- Conditions
- Asthma
- Being tested
- Asthma Coaching Program, Usual Care
- Keywords
- Consumer Participation, Telephone Coaching Program
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Asthma Coaching ProgramBehavioural
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.
Usual CareBehavioural
Children of parents enrolled in the study will receive the normal asthma care that their pediatricians usually provide.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Pediatricians and parents of children with asthma will participate in the asthma coaching program. Receives: Behavioral: Asthma Coaching Program |
| 2 | Active comparator | Children of parents enrolled in the study will receive usual asthma care from their pediatrician. Receives: Behavioral: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Asthma control
Measured: Measured at Months 12 and 24
Asthma-related quality of life
Measured: Measured at Months 12 and 24
Urgent care events
Measured: Measured at Months 12 and 24
Secondary outcomes (2)
Adherence to guideline-recommended asthma maintenance care behaviors
Measured: Measured at Months 12 and 24
Cost effectiveness
Measured: Measured at Months 12 and 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2009 (estimated)
- Study startAug 2008
- Primary completion3 May 2013
- Study completion3 May 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 984 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Jane Garbutt, MD, Washington University School of Medicine
- Investigators
- Jane M. Garbutt, MB, ChB, Principal investigator, Washington University School of MedicineRobert Strunk, MD, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00860834
- Sponsor's protocol ID
- 634
- Other IDs
- R01HL072919, R01HL072919-06
- Acronym
- PARTNER
- Status last verified
- Oct 2018
- First submitted
- 10 Mar 2009
- Last updated
- 3 Oct 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 22469168Garbutt 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.
PubMed 25445827
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Parents, Pediatricians, and Telephone Coaches Partner to Improve Control of Asthma
- ClinicalTrials.gov ID
- NCT00860834
- Acronym / sponsor ID
- PARTNER / 634
- Conditions
- Asthma
- Keywords
- Consumer Participation, Telephone Coaching Program
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 984 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Aug 2008 (actual)
- Primary completion
- 3 May 2013 (actual)
- Study completion
- 3 May 2014 (actual)
- First posted
- 12 Mar 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: Asthma Coaching ProgramPediatricians and parents of children with asthma will participate in the asthma coaching program. |
| 2 | Active comparator | Behavioral: Usual CareChildren of parents enrolled in the study will receive usual asthma care from their pediatrician. |
Who may qualify
- Ages
- 3 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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
- Has a child who is between 3 and 12 years old with persistent asthma and who is cared for by a study pediatrician
Key exclusion criteria (8 listed)
- 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
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Asthma Coaching ProgramParents 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. | Behavioural | 1 |
| Usual CareChildren of parents enrolled in the study will receive the normal asthma care that their pediatricians usually provide. | Behavioural | 2 |
Primary outcome
Asthma control
Time frame: Measured at Months 12 and 24
Asthma-related quality of life
Time frame: Measured at Months 12 and 24
Urgent care events
Time frame: Measured at Months 12 and 24
2 secondary outcomes
Adherence to guideline-recommended asthma maintenance care behaviors
Time frame: Measured at Months 12 and 24
Cost effectiveness
Time frame: Measured at Months 12 and 24
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2018.
- Background: PubMed 22469168Garbutt 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.
- Derived from this study: PubMed 25445827Garbutt 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.
Related trials for Asthma
RecruitingPhase 1
Pilot Study to Identify the Mediators and Inflammatory Cell Surface Receptors Involved in Allergic Airway Inflammation
Asthma
RecruitingPhase 1
A Study to Compare the Relative Potency of Salbutamol Administered Via Metered Dose Inhalers (MDI) Containing Propellants HFA-152a to HFA-134a in Mild Asthmatics Aged 18 to 65 Inclusive
Asthma, Mild Asthma
RecruitingPhase 3
A Study Assessing the Effect of Dupilumab on Inducing Clinical Remission in Asthma
Asthma Control
Active, not recruitingPhase 2/3
Local Antibiotic Delivery for Community Acquired Pneumonia
Community Acquired Pneumonia (CAP)
RecruitingPhase 2
A Study to Learn About the Study Medicine Called PF-07275315 in People With Moderate-To-Severe Asthma
Asthma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jane M. Garbutt, MB, ChB principal investigator
Washington University School of Medicine
Robert Strunk, MD principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Asthma Coaching Program in people with Asthma, run by Washington University School of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Asthma control (time frame: Measured at Months 12 and 24). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00860834, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2018.