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

November 13, 2017 updated by: Tania Condurache, University of Louisville

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

144

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • Norton Children's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years to 12 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Previous enrollment in either group of this study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Reinforced Education

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.
Behavioral: Reinforced Asthma Education

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.
No Intervention: No Reinforced Education

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Asthma Knowledge Scores (AKS)
Time Frame: 3 months
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.
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Asthma Knowledge Retention Rates (AKRR)
Time Frame: 2 weeks, 1 month, and 3 months after the initial educational intervention
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).
2 weeks, 1 month, and 3 months after the initial educational intervention
Quality of Life/Asthma Control Test Scores (QOL/ACT Scores)
Time Frame: At enrollment; 2 weeks, 1 month and 3 months after enrollment

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.
At enrollment; 2 weeks, 1 month and 3 months after enrollment
Functional Status
Time Frame: Enrollment; 2 weeks, 1 month and 3 months after enrollment
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.
Enrollment; 2 weeks, 1 month and 3 months after enrollment
Asthma-related healthcare costs
Time Frame: 6 months after enrollment

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.
6 months after enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Louisville

Collaborators

Passport Health

Investigators

  • Principal Investigator: Carmen T Condurache, M.D., University of Louisville

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2011

Primary Completion (Actual)

October 1, 2012

Study Completion (Actual)

October 1, 2012

Study Registration Dates

First Submitted

September 27, 2011

First Submitted That Met QC Criteria

October 4, 2011

First Posted (Estimate)

October 6, 2011

Study Record Updates

Last Update Posted (Actual)

November 17, 2017

Last Update Submitted That Met QC Criteria

November 13, 2017

Last Verified

November 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Asthma IHOP - 2011

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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