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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
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

Other trials in United States

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:

    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.
Study groups in NCT00660322
Study groupRoleWhat they receive
ControlNo interventionFamilies assigned to the control arm will receive usual asthma care from the child's primary care provider.
InterventionExperimentalThe 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.

  1. Parental asthma-related quality of life

    Measured: one year

  2. 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.

  1. First posted17 Apr 2008 (estimated)
  2. Study startJan 2004
  3. Primary completionJan 2006
  4. Study completionJun 2007

Resources

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)
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 17660103
  • Garbutt 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

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.

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