AsthmaNCT00660322
Using the Telephone to Improve Care in Childhood Asthma
A study testing Telephone Asthma Program in people with Asthma, run by Agency for Healthcare Research and Quality (AHRQ) at 1 site in United States.
Trial summary
Asthma is the most common chronic disease of childhood and a major cause of morbidity in the United States. If asthma symptoms are controlled, a child with asthma can stay well and lead a normal life. Read more about this study
- Who is it for?
- Ages 5 to 12 years
- Conditions the study is for
- Asthma
- What is being tested?
- Telephone Asthma Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 362 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2004to Jun 2007
- 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 5 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Physician diagnosis of asthma for at least a year
- At least one acute exacerbation of asthma in past 12 months that required a visit to the emergency department, hospitalization or an unscheduled office visit for acute care and/or a course of oral steroids.
- Taking daily controller medications or symptoms consistent with persistent asthma
Who cannot join
- No phone
- Unable to speak English
- Child has another disease that requires regular monitoring by pediatrician
- A sibling is already enrolled in the study
- Child's primary asthma provider is an asthma specialist
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
Asthma is the most common chronic disease of childhood and a major cause of morbidity in the United States. If asthma symptoms are controlled, a child with asthma can stay well and lead a normal life. Daily use of inhaled steroids controls symptoms and reduces morbidity and emergent health care utilization in children with persistent asthma, and is safe for long-term use. However, inhaled steroids are underused in community asthma care.
The Telephone Asthma Program (TAP) is a series of brief, telephone calls with a trained coach to help the parent manage the child's asthma care. The coach will teach self-management skills, help the parent to use the child's asthma medicines effectively, provide support and remind the parent to go for follow-up care with the pediatrician. We hypothesized that the Telephone Asthma Program will reduce the incidence of acute exacerbations of asthma that require emergent care, improve the quality of life of children with asthma and their parents, and increase the daily use of inhaled steroids in children with persistent asthma. We evaluated the Telephone Asthma Program in a randomized controlled trial involving 362 children aged 5 to 12 years old cared for by community pediatricians. Eligible children were randomized to the TAP program or usual care by their pediatrician.
Read the detailed description
Asthma morbidity is largely preventable with effective maintenance care. National guidelines recommend 1) daily treatment with inhaled corticosteroids (ICS) to prevent asthma symptoms and activity limitations, minimize acute exacerbations and maintain normal lung function; 2) early intervention guided by a written Asthma Action Plan for worsening symptoms;3) a partnership between the primary care provider, the patient and their family to develop shared treatment goals, select an appropriate treatment plan, resolve asthma-related concerns, and provide support for day-to-day care, and 4) periodic assessments (every 1 to 6 months) by the physician to monitor asthma control and assess if the goals of therapy are being met, with asthma self-management education provided at diagnosis and reinforced at every opportunity. Despite widespread dissemination of these guidelines, under-use of controller medications is pervasive, home management of an acute exacerbation is often delayed and inadequate, and only 50% of asthmatic children report maintenance care visits twice a year. Most primary care pediatricians do not provide education about use of preventive treatments or self-management behaviors citing lack of confidence in their ability to effect change, logistical issues such as lack of time, educational materials, support staff, and inadequate reimbursement as significant barriers to these activities. Practical, efficient interventions to improve maintenance asthma care in office-practice are needed.
In response to complaints from community pediatricians in our practice-based research network that few children with persistent asthma used their controller medications as prescribed we collaborated with local asthma experts and the telephone triage service at our children's hospital to develop and evaluate a 12-month telephone-coaching program to provide education and support to parents to improve asthma self-management for their children. The Telephone Asthma Program (TAP) was provided in addition to usual care, and was evaluated in a randomized controlled trial (RCT).
The TAP program was based on the Transtheoretical Model of Behavior Change developed by James Prochaska. This model postulates a series of 5 ordered stages of readiness to change to a desired behavior (Precontemplation, Contemplation, Preparation, Action and Maintenance). The desired behaviors for TAP were: 1) using controller medications as prescribed, 2) administering rescue medications at the child's first signs of an asthma exacerbation, 3) having an up-to-date asthma action plan readily available for all who may need it, and 4) having a collaborative relationship with the child's PCP that included regular asthma check-up visits at least every 6 months. Our goal was that all 4 behaviors would be addressed by the coach for each parent throughout the 12-month program period. Guided by computerized telephone protocols the coach provided tailored care advice appropriate for the parent's stage of readiness for behavior change. In this way, the coach could provide education and support to help the parent to provide effective asthma care at home for their child, and supplement the care provided by the physician.
- Conditions
- Asthma
- Being tested
- Telephone Asthma Program
- Keywords
- Asthma, Telemedicine, Randomized controlled trial
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telephone Asthma ProgramBehavioural
The parent will have access to a trained asthma coach for 12 months. The coach will call the parents at mutually convenient times (up to 12 times a year) to work on 4 targeted asthma behaviors:
- Using asthma controller medications as prescribed
- Having and Asthma Action Plan available to all who may need it.
- Using asthma rescue medications with the child's first symptoms.
- Having a collaborative relationship with the child's primary care provider that includes asthma check-ups at least twice a year.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Families assigned to the control arm will receive usual asthma care from the child's primary care provider. |
| Intervention | Experimental | The Telephone Asthma Program and usual care. Receives: Behavioral: Telephone Asthma Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Parental asthma-related quality of life
Measured: one year
Urgent care events for asthma
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2008 (estimated)
- Study startJan 2004
- Primary completionJan 2006
- Study completionJun 2007
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.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 362 participants (actual)
Sponsor and investigators
- Lead sponsor
- Agency for Healthcare Research and Quality (AHRQ)
- Sponsor type
- US federal agency
- Investigators
- Jane Garbutt, MD, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00660322
- Sponsor's protocol ID
- HS015378
- Status last verified
- Apr 2008
- First submitted
- 15 Apr 2008
- Last updated
- 17 Apr 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
Garbutt J, Bloomberg G, Banister C, Sterkel R, Epstein J, Bruns J, Swerczek L, Wells S. What constitutes maintenance asthma care? The pediatrician's perspective. Ambul Pediatr. 2007 Jul-Aug;7(4):308-12. doi: 10.1016/j.ambp.2007.03.007.
PubMed 17660103Garbutt JM, Banister C, Highstein G, Sterkel R, Epstein J, Bruns J, Swerczek L, Wells S, Waterman B, Strunk RC, Bloomberg GR. Telephone coaching for parents of children with asthma: impact and lessons learned. Arch Pediatr Adolesc Med. 2010 Jul;164(7):625-30. doi: 10.1001/archpediatrics.2010.91.
PubMed 20603462
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using the Telephone to Improve Care in Childhood Asthma
- ClinicalTrials.gov ID
- NCT00660322
- Acronym / sponsor ID
- HS015378
- Conditions
- Asthma
- Keywords
- Asthma, Telemedicine, Randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 362 participants (actual)
- Lead sponsor
- Agency for Healthcare Research and Quality (AHRQ)US federal agency
- Study start
- Jan 2004
- Primary completion
- Jan 2006 (actual)
- Study completion
- Jun 2007 (actual)
- First posted
- 17 Apr 2008 (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.
Asthma is the most common chronic disease of childhood and a major cause of morbidity in the United States. If asthma symptoms are controlled, a child with asthma can stay well and lead a normal life. Daily use of inhaled steroids controls symptoms and reduces morbidity and emergent health care utilization in children with persistent asthma, and is safe for long-term use. However, inhaled steroids are underused in community asthma care.
The Telephone Asthma Program (TAP) is a series of brief, telephone calls with a trained coach to help the parent manage the child's asthma care. The coach will teach self-management skills, help the parent to use the child's asthma medicines effectively, provide support and remind the parent to go for follow-up care with the pediatrician. We hypothesized that the Telephone Asthma Program will reduce the incidence of acute exacerbations of asthma that require emergent care, improve the quality of life of children with asthma and their parents, and increase the daily use of inhaled steroids in children with persistent asthma. We evaluated the Telephone Asthma Program in a randomized controlled trial involving 362 children aged 5 to 12 years old cared for by community pediatricians. Eligible children were randomized to the TAP program or usual care by their pediatrician.
Detailed description
Asthma morbidity is largely preventable with effective maintenance care. National guidelines recommend 1) daily treatment with inhaled corticosteroids (ICS) to prevent asthma symptoms and activity limitations, minimize acute exacerbations and maintain normal lung function; 2) early intervention guided by a written Asthma Action Plan for worsening symptoms;3) a partnership between the primary care provider, the patient and their family to develop shared treatment goals, select an appropriate treatment plan, resolve asthma-related concerns, and provide support for day-to-day care, and 4) periodic assessments (every 1 to 6 months) by the physician to monitor asthma control and assess if the goals of therapy are being met, with asthma self-management education provided at diagnosis and reinforced at every opportunity. Despite widespread dissemination of these guidelines, under-use of controller medications is pervasive, home management of an acute exacerbation is often delayed and inadequate, and only 50% of asthmatic children report maintenance care visits twice a year. Most primary care pediatricians do not provide education about use of preventive treatments or self-management behaviors citing lack of confidence in their ability to effect change, logistical issues such as lack of time, educational materials, support staff, and inadequate reimbursement as significant barriers to these activities. Practical, efficient interventions to improve maintenance asthma care in office-practice are needed.
In response to complaints from community pediatricians in our practice-based research network that few children with persistent asthma used their controller medications as prescribed we collaborated with local asthma experts and the telephone triage service at our children's hospital to develop and evaluate a 12-month telephone-coaching program to provide education and support to parents to improve asthma self-management for their children. The Telephone Asthma Program (TAP) was provided in addition to usual care, and was evaluated in a randomized controlled trial (RCT).
The TAP program was based on the Transtheoretical Model of Behavior Change developed by James Prochaska. This model postulates a series of 5 ordered stages of readiness to change to a desired behavior (Precontemplation, Contemplation, Preparation, Action and Maintenance). The desired behaviors for TAP were: 1) using controller medications as prescribed, 2) administering rescue medications at the child's first signs of an asthma exacerbation, 3) having an up-to-date asthma action plan readily available for all who may need it, and 4) having a collaborative relationship with the child's PCP that included regular asthma check-up visits at least every 6 months. Our goal was that all 4 behaviors would be addressed by the coach for each parent throughout the 12-month program period. Guided by computerized telephone protocols the coach provided tailored care advice appropriate for the parent's stage of readiness for behavior change. In this way, the coach could provide education and support to help the parent to provide effective asthma care at home for their child, and supplement the care provided by the physician.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Families assigned to the control arm will receive usual asthma care from the child's primary care provider. |
| Intervention | Experimental | Behavioral: Telephone Asthma ProgramThe Telephone Asthma Program and usual care. |
Who may qualify
- Ages
- 5 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Physician diagnosis of asthma for at least a year
- At least one acute exacerbation of asthma in past 12 months that required a visit to the emergency department, hospitalization or an unscheduled office visit for acute care and/or a course of oral steroids.
- Taking daily controller medications or symptoms consistent with persistent asthma
Key exclusion criteria (5 listed)
- No phone
- Unable to speak English
- Child has another disease that requires regular monitoring by pediatrician
- A sibling is already enrolled in the study
- Child's primary asthma provider is an asthma specialist
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 |
|---|---|---|
| Telephone Asthma ProgramThe parent will have access to a trained asthma coach for 12 months. The coach will call the parents at mutually convenient times (up to 12 times a year) to work on 4 targeted asthma behaviors: 1. Using asthma controller medications as prescribed 2. Having and Asthma Action Plan available to all who may need it. 3. Using asthma rescue medications with the child's first symptoms. 4. Having a collaborative relationship with the child's primary care provider that includes asthma check-ups at least twice a year. | Behavioural | Intervention |
Primary outcome
Parental asthma-related quality of life
Time frame: one year
Urgent care events for asthma
Time frame: One year
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 17 Apr 2008.
- Background: PubMed 17660103Garbutt J, Bloomberg G, Banister C, Sterkel R, Epstein J, Bruns J, Swerczek L, Wells S. What constitutes maintenance asthma care? The pediatrician's perspective. Ambul Pediatr. 2007 Jul-Aug;7(4):308-12. doi: 10.1016/j.ambp.2007.03.007.
- Derived from this study: PubMed 20603462Garbutt JM, Banister C, Highstein G, Sterkel R, Epstein J, Bruns J, Swerczek L, Wells S, Waterman B, Strunk RC, Bloomberg GR. Telephone coaching for parents of children with asthma: impact and lessons learned. Arch Pediatr Adolesc Med. 2010 Jul;164(7):625-30. doi: 10.1001/archpediatrics.2010.91.
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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 Garbutt, 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 Telephone Asthma Program in people with Asthma, run by Agency for Healthcare Research and Quality (AHRQ) 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 5 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 17 Apr 2008. 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?
Parental asthma-related quality of life (time frame: one year). The study lists 2 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 NCT00660322, 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 17 Apr 2008.