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AsthmaNCT00269282

Increasing Adherence to Asthma Medication in Urban Teens

A study testing Self-Management Training and Motivational Interviewing (MI) in people with Asthma, run by Johns Hopkins University 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

The purpose of this study is to determine the effectiveness of two home-based asthma interventions in increasing adherence to daily asthma controller medication. Read more about this study

Who is it for?
Ages 10 to 15 years
Conditions the study is for
Asthma
What is being tested?
Self-Management Training and Motivational Interviewing (MI)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
207 participants
Where
1 siteUnited States
Study dates
May 2006to Jan 2012
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 10 to 15 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Resident of Baltimore City
  • Diagnosis of asthma or reactive airway disease
  • Current emergency department visit or hospitalization for asthma
  • Prescribed a daily asthma controller medication

Who cannot join

  • Plans to move outside of the Baltimore City area within 1 year from study entry
  • Current participation in another asthma education study
  • Families unwilling or unable to participate
  • Families who were enrolled and participated in the pilot study

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Johns Hopkins Hospital Pediatric Emergency Department

    Baltimore, Maryland, 21287

Other trials in United States

About this study

Official title: Motivating Asthma Adherence in Urban Teens

The purpose of this study is to determine the effectiveness of two home-based asthma interventions in increasing adherence to daily asthma controller medication.

Read the detailed description

BACKGROUND:

Low-income, minority teenagers have disproportionately high rates of asthma morbidity, including excess risk of emergency department (ED) care, hospitalization, and death from asthma, compared to white adolescents. Research by this group and others has documented that non-adherence with asthma treatment regimens is common among high-risk, inner city families with asthma, and that this poor adherence with prescribed therapies plays a significant contributing role in asthma morbidity. Inner-city adolescents with asthma are at particular risk of non-adherence, yet this population remains understudied. While asthma self-management training has shown promise in achieving some improvement in adherence with asthma, there are few intervention studies explicitly targeting adolescents, particularly those in the inner-city. Urban children typically assume primary control over their asthma management during late childhood/early adolescence. At the same time, adolescents' efforts to achieve autonomy and peer-acceptance may result in increased health risk behaviors, including poor asthma self-management. Developmentally-appropriate asthma self-management interventions are needed that target the unique challenges of adolescence. Motivational Interviewing (MI) is a promising interventional approach that uses a client-centered, non-directive approach for enhancing motivation to change health behaviors. MI techniques are developmentally consistent with the needs of early adolescents. MI does not assume that health will be the most important factor motivating the teen, but rather acknowledges and incorporates other motivators that are within the context of the teen's life, thus this intervention strategy has the flexibility to adapt to the unique life circumstances and stressors faced by urban adolescents. We propose to evaluate the relative effectiveness of a MI-focused self-management intervention (MI+SM) compared to a self-management (SM) intervention containing asthma education and self-monitoring strategies in a sample of 226 children age 10-15 years treated for asthma in the ED. Our primary hypothesis is that the MI+SM, as compared to SM alone, will result in greater improvement in medication adherence at 3- and 6-months post-randomization, as measured by electronic medication monitoring. Secondary outcomes include self-reported medication adherence, symptoms free days, urgent health care utilization for asthma, and caregiver/adolescent quality of life.

DESIGN NARRATIVE:

Participants will be randomly assigned to 1) Self-Management (SM; Standard Care Group) or 2) Motivational Interviewing plus Self-Management Training (MI+SM; Intervention Group). The duration of the intervention condition will be 5 home visits over 2 months. Follow-up measures will be collected from families at 3- and 6-months post-randomization.

Conditions
Asthma
Being tested
Self-Management Training, Motivational Interviewing (MI)
Medical subject headings
Asthma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Self-Management TrainingBehavioural

    Asthma education and self-monitoring strategies

  • Motivational Interviewing (MI)Behavioural

    Motivational Interviewing (MI) is a promising interventional approach that uses a client-centered, non-directive approach for enhancing motivation to change health behaviors.

Study groups in NCT00269282
Study groupRoleWhat they receive
1Active comparatorSelf-Management (SM) (Standard Care Group)
Receives: Behavioral: Self-Management Training
2ExperimentalMotivational Interviewing plus Self-Management Training (MI+SM)
Receives: Behavioral: Self-Management Training; Behavioral: Motivational Interviewing (MI)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Adherence to asthma controller therapy as measured by electronic medication monitoring

    Measured: Measured at baseline, 3 months, and 6 months

Secondary outcomes (3)
  1. Number of symptom-free days

    Measured: Measured at baseline, 3 months, and 6 months

  2. Emergency department utilization and hospitalization

    Measured: Measured at baseline, 3 months, and 6 months

  3. Caregiver/adolescent quality of life

    Measured: Measured at baseline, 3 months, and 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Dec 2005 (estimated)
  2. Study startMay 2006
  3. Primary completionJan 2012
  4. Study completionJan 2012

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
207 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00269282
Sponsor's protocol ID
321
Other IDs
R01HL079301
Status last verified
Jan 2013
First submitted
21 Dec 2005
Last updated
14 Jan 2013
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A study testing Self-Management Training and Motivational Interviewing (MI) in people with Asthma, run by Johns Hopkins University 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 4 inclusion and 4 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 14 Jan 2013. 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?

Adherence to asthma controller therapy as measured by electronic medication monitoring (time frame: Measured at baseline, 3 months, and 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 14 Jan 2013.

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