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AsthmaIHOPNCT01447459

Effects of Educational Intervention on Long-Term Outcomes of Hospitalized Children With Asthma

A study testing Reinforced Asthma Education in people with Asthma, run by University of Louisville 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 investigators hypothesize that reinforced asthma education improves long-term outcomes in children with asthma. Specific Aims and Objectives: 1. To determine the retention rate of parental knowledge about asthma; 2. Read more about this study

Who is it for?
Ages 5 to 12 years
Conditions the study is for
Asthma
What is being tested?
Reinforced Asthma Education
Could I receive a placebo?
No, everyone receives an active treatment
How many people
144 participants
Where
1 siteUnited States
Study dates
Feb 2011to Oct 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 5 to 12 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Children age 5-12 years (eligible on or after the 5th birthday, until the day before the 13th birthday);
  • Hospitalized at Norton Children's Hospital (KCH) for asthma;
  • Physician diagnosis of asthma (ICD-9 codes 493.00, 493.01, 493.02, 493.10, 493.11, 493.12, 493.90, 493.91, 493.92);
  • Completion of asthma education (standard of care);
  • Ability of parent/legal guardian to give informed consent/research authorization, as evidenced by signing the Informed Consent Form (ICF) approved by the University of Louisville (UofL) IRB;
  • Ability of subject to give informed assent for subjects equal to or older than 7 years of age, as evidenced by signing the Informed Assent Form (IAF) approved by UofL IRB.

Who cannot join

  • Previous enrollment in either group of this study.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Norton Children's Hospital

    Louisville, Kentucky, 40202

Other trials in United States

About this study

The investigators hypothesize that reinforced asthma education improves long-term outcomes in children with asthma.

Specific Aims and Objectives:

  1. To determine the retention rate of parental knowledge about asthma;
  2. To evaluate the clinical status, quality of life and healthcare costs of children with asthma following an educational intervention.
Read the detailed description

This study will be a prospective, randomized (1:1), controlled study assessing clinical status, quality of life, healthcare costs and parental retention rate of asthma knowledge for children 5 to 12 years old with asthma, following standardized asthma education versus standard education with an enhanced reinforcement of education intervention.

Group A (the intervention group) The caregivers of the subjects enrolled in this group will be administered two survey instruments at enrollment (t0), and again via telephone at 2 weeks (t1), 1 months (t2), and 3 months (t3) after enrollment. This group will also receive reinforced asthma education via telephone at 2 weeks, 1 month, and 3 months after enrollment.

Group B (the control group) The caregivers of the subjects enrolled in this group will be administered two survey instruments at enrollment (t0), and again via telephone at 2 weeks (t1), 1 month (t2), and 3 months (t3) after enrollment. This group will not receive reinforcing of the asthma education at 2 weeks, 1 month, and 3 months after enrollment.

The two survey instruments administered to the caregivers (parents/legal guardians) of the subjects enrolled in this study consist of:

  1. A validated 16-item questionnaire with multiple-choice answers, assessing asthma knowledge, trigger identification and avoidance, referred to as "the Asthma Knowledge Quiz" from here on.
  2. A validated 5-item questionnaire with multiple-choice answers, assessing the patient's quality of life and asthma control, referred to as "the Quality of Life/Asthma Control Test (QOL/ACT) survey" from here on.

Following enrollment and randomization, the caregiver of each subject will be administered the two survey instruments prior to discharge from the hospital.

At the end of the administration of the phone surveys (i.e. at 2 weeks, 1 month and 3 months following enrollment), the study coordinator will provide reinforced asthma education to the caregiver via telephone for the subjects enrolled in Group A (the intervention group). The reinforced asthma education will be consistent with the asthma education training session delivered by the AE before the beginning of the study.

The survey instruments will be administered to the caregiver by the study coordinator in paper form; after completion by the caregiver, the form will be saved in the subject's research binder for further data analysis. The PI or the study coordinator will determine the score for each item on the surveys, and record the scores in the subject's file, in the Asthma Knowledge Quiz Scores/Asthma Knowledge Retention Rates Form, and the Quality of Life/Asthma Control Test (QOL/ACT) Scores Form respectively.

The caregiver of each subject will be administered these two survey instruments again, via telephone, by the study coordinator, at 2 weeks, 1 month, and 3 months after enrollment. Each item and the multiple-choice answers will be literally read to the parent over the phone, and the study coordinator will record the answers to each item on the paper survey forms, which will be saved in the subject's binder for further data analysis. The PI or the study coordinator will determine the score for each survey, and record the scores in the subject's file.

A variety of statistical techniques will be used to analyze the data. The investigators will perform descriptive analyses as well as more analytic work using analysis of variance, correlation and multiple regression analysis. The investigators will use the expertise of a biostatistician to assist with accurate analysis of our data. The study will be powered to detect a significant difference in outcomes between the intervention group (group A) and the control group (group B); 25 % reduction in cost an 25% improvement in quality of life scores, following reinforced asthma education, with a 95% CI (alpha=0.05, beta=0.2, for a power of 80%). The investigators will also analyze whether there is a statistically significant correlation between the amplitude of the asthma knowledge scores (AKS) and the asthma knowledge retention rates (AKRR) on one side and the QOL/ACT scores, functional status and asthma related healthcare costs on the other side.

Conditions
Asthma
Being tested
Reinforced Asthma Education
Keywords
Asthma, Asthma Education
Medical subject headings
Asthma

What participants receive

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

  • Reinforced Asthma EducationBehavioural

    Before beginning the actual study, a board-certified Asthma Educator (AE) will prepare and administer an asthma education training session for the study personnel, including the PI, the co-investigators, and the study coordinator. The AE will also make herself available via pager for assistance with questions from the study personnel regarding asthma education.

    At the end of the administration of the phone surveys (i.e. at 2 weeks, 1 month and 3 months following enrollment), the study coordinator will provide reinforced asthma education to the caregiver via telephone for the subjects enrolled in Group A (the intervention group). The reinforced asthma education will be consistent with the asthma education training session delivered by the AE before the beginning of the study.

Study groups in NCT01447459
Study groupRoleWhat they receive
Reinforced EducationExperimentalThe caregivers of the subjects enrolled in this group will be administered two survey instruments at enrollment (t0), and again via telephone at 2 weeks (t1), 1 months (t2), and 3 months (t3) after enrollment. This group will also receive reinforced asthma education via telephone at 2 weeks, 1 month, and 3 months after enrollment.
Receives: Behavioral: Reinforced Asthma Education
No Reinforced EducationNo interventionThe caregivers of the subjects enrolled in this group will be administered two survey instruments at enrollment (t0), and again via telephone at 2 weeks (t1), 1 month (t2), and 3 months (t3) after enrollment. This group will not receive reinforcing of the asthma education at 2 weeks, 1 month, and 3 months after enrollment.

What is being measured

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

  1. Asthma Knowledge Scores (AKS)

    The Asthma Knowledge Quiz will be administered. The higher the score (AKS), the better the knowledge of the caregiver regarding asthma, symptom recognition, trigger identification and avoidance, and medication administration. The PI or the study coordinator will calculate AKSt0, AKSt1, AKSt2, and AKSt3 (enrollment, 1 week, 2 weeks and 3 months, respectively) for each caregiver enrolled in the study. These scores will be recorded in the Asthma Knowledge Quiz Score/Asthma Knowledge Retention Rates Form for each individual subject.

    Measured: 3 months

Secondary outcomes (4)

  1. Asthma Knowledge Retention Rates (AKRR)

    The Asthma Knowledge Retention Rates (AKRR) will be defined as the ratio between the AKS at different times during the study (i.e., t1, t2, or t3 respectively), and the AKS at baseline (AKSt0).

    Measured: 2 weeks, 1 month, and 3 months after the initial educational intervention

  2. Quality of Life/Asthma Control Test Scores (QOL/ACT Scores)

    Quality of Life/Asthma Control (QOL/ACT) Test - each answer to 5 questions will be assigned a numeric score.

    The QOL/ACT score calculates as the sum of the scores for answers to items Q1 through Q5 for each subject. The higher the score, the better the quality of life of the patient, and the better the control achieved on asthma.

    Measured: At enrollment; 2 weeks, 1 month and 3 months after enrollment

  3. Functional Status

    Functional status will be determined by the asthma-related number of days of school absenteeism for each subject enrolled in the study. The study coordinator will collect this information from the caregivers during the follow-up phone calls at t1, t2, and t3, and record it as part of the Relevant Medical Records Form for each individual subject.

    Measured: Enrollment; 2 weeks, 1 month and 3 months after enrollment

  4. Asthma-related healthcare costs

    Asthma-related healthcare costs will be assessed for each subject enrolled in the study for 6 months from enrollment (t0). These costs will be calculated as the sum of the asthma-related avoidable health-care costs for the study period, including:

    • Unplanned visits to the PCP or Immediate Care Centers;
    • ED visits;
    • Hospitalizations to the pediatric ward, TCU, or PICU.

    Measured: 6 months after enrollment

Timeline

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

  1. First posted6 Oct 2011 (estimated)
  2. Study startFeb 2011
  3. Primary completionOct 2012
  4. Study completionOct 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
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Care provider
Enrolment
144 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01447459
Sponsor's protocol ID
Asthma IHOP - 2011
Acronym
IHOP
Status last verified
Nov 2017
First submitted
27 Sep 2011
Last updated
17 Nov 2017
Results posted
No
Data monitoring committee
No

Publications

  • Braman SS, Vigg A. The National Asthma Education and Prevention Program (NAEPP) guidelines: will they improve the quality of care in America? Med Health R I. 2008 Jun;91(6):166-8. No abstract available.

    PubMed 18610803

  • Bryant-Stephens T, Li Y. Community asthma education program for parents of urban asthmatic children. J Natl Med Assoc. 2004 Jul;96(7):954-60.

    PubMed 15253327

  • Bravata DM, Gienger AL, Holty JE, Sundaram V, Khazeni N, Wise PH, McDonald KM, Owens DK. Quality improvement strategies for children with asthma: a systematic review. Arch Pediatr Adolesc Med. 2009 Jun;163(6):572-81. doi: 10.1001/archpediatrics.2009.63.

    PubMed 19487615

  • Coffman JM, Cabana MD, Halpin HA, Yelin EH. Effects of asthma education on children's use of acute care services: a meta-analysis. Pediatrics. 2008 Mar;121(3):575-86. doi: 10.1542/peds.2007-0113.

    PubMed 18310208

  • Guevara JP, Wolf FM, Grum CM, Clark NM. Effects of educational interventions for self management of asthma in children and adolescents: systematic review and meta-analysis. BMJ. 2003 Jun 14;326(7402):1308-9. doi: 10.1136/bmj.326.7402.1308.

    PubMed 12805167

  • Gupta RS, Weiss KB. The 2007 National Asthma Education and Prevention Program asthma guidelines: accelerating their implementation and facilitating their impact on children with asthma. Pediatrics. 2009 Mar;123 Suppl 3:S193-8. doi: 10.1542/peds.2008-2233J.

    PubMed 19221163

  • Nathan RA, Sorkness CA, Kosinski M, Schatz M, Li JT, Marcus P, Murray JJ, Pendergraft TB. Development of the asthma control test: a survey for assessing asthma control. J Allergy Clin Immunol. 2004 Jan;113(1):59-65. doi: 10.1016/j.jaci.2003.09.008.

    PubMed 14713908

  • Nicholas DB, Dell SD, Fleming-Carroll B, Selkirk EK. An evaluation of pediatric asthma educational resources. Soc Work Health Care. 2009;48(4):450-61. doi: 10.1080/00981380802589936.

    PubMed 19396712

  • McPherson AC, Glazebrook C, Forster D, James C, Smyth A. A randomized, controlled trial of an interactive educational computer package for children with asthma. Pediatrics. 2006 Apr;117(4):1046-54. doi: 10.1542/peds.2005-0666.

    PubMed 16585298

  • Murphy KR, Zeiger RS, Kosinski M, Chipps B, Mellon M, Schatz M, Lampl K, Hanlon JT, Ramachandran S. Test for respiratory and asthma control in kids (TRACK): a caregiver-completed questionnaire for preschool-aged children. J Allergy Clin Immunol. 2009 Apr;123(4):833-9.e9. doi: 10.1016/j.jaci.2009.01.058.

    PubMed 19348922

  • Lara M, Rosenbaum S, Rachelefsky G, Nicholas W, Morton SC, Emont S, Branch M, Genovese B, Vaiana ME, Smith V, Wheeler L, Platts-Mills T, Clark N, Lurie N, Weiss KB. Improving childhood asthma outcomes in the United States: a blueprint for policy action. Pediatrics. 2002 May;109(5):919-30. doi: 10.1542/peds.109.5.919.

    PubMed 11986457

  • Taggart VS, Zuckerman AE, Sly RM, Steinmueller C, Newman G, O'Brien RW, Schneider S, Bellanti JA. You Can Control Asthma: evaluation of an asthma education program for hospitalized inner-city children. Patient Educ Couns. 1991 Feb;17(1):35-47. doi: 10.1016/0738-3991(91)90049-b.

    PubMed 1997997

  • Wang LY, Zhong Y, Wheeler L. Direct and indirect costs of asthma in school-age children. Prev Chronic Dis. 2005 Jan;2(1):A11. Epub 2004 Dec 15.

    PubMed 15670464

  • Asthma prevalence, Health Care Use and Mortality, 2002. National Center for Health Statistics, Health Data for All Ages (HDAA). http://www.cdc.gov/nchs/products/pubs/pubd/hestats/asthma/asthma.htm.

Questions about this trial

What is this clinical trial studying?

A study testing Reinforced Asthma Education in people with Asthma, run by University of Louisville 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 6 inclusion and 1 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 Nov 2017. 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 Knowledge Scores (AKS) (time frame: 3 months). 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 NCT01447459, which also lists 14 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 Nov 2017.

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