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

This study has been completed.
Sponsor:
Collaborator:
Passport Health
Information provided by (Responsible Party):
University of Louisville
ClinicalTrials.gov Identifier:
NCT01447459
First received: September 27, 2011
Last updated: May 22, 2013
Last verified: July 2012
  Purpose

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.

Condition Intervention
Asthma
Behavioral: Reinforced Asthma Education

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Caregiver)
Primary Purpose: Supportive Care
Official Title: Effects of Educational Intervention on Long-Term Outcomes of Hospitalized Children With Asthma

Resource links provided by NLM:


Further study details as provided by University of Louisville:

Primary Outcome Measures:
  • Asthma Knowledge Scores (AKS) [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Asthma Knowledge Retention Rates (AKRR) [ Time Frame: 2 weeks, 1 month, and 3 months after the initial educational intervention ] [ Designated as safety issue: No ]
    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).

  • Quality of Life/Asthma Control Test Scores (QOL/ACT Scores) [ Time Frame: At enrollment; 2 weeks, 1 month and 3 months after enrollment ] [ Designated as safety issue: No ]

    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.


  • Functional Status [ Time Frame: Enrollment; 2 weeks, 1 month and 3 months after enrollment ] [ Designated as safety issue: No ]
    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.

  • Asthma-related healthcare costs [ Time Frame: 6 months after enrollment ] [ Designated as safety issue: No ]

    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.


Enrollment: 144
Study Start Date: February 2011
Study Completion Date: October 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.


  Show Detailed Description

  Eligibility

Ages Eligible for Study:   5 Years to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Children age 5-12 years (eligible on or after the 5th birthday, until the day before the 13th birthday);
  • Hospitalized at Kosair 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01447459

Locations
United States, Kentucky
Kosair Children's Hospital
Louisville, Kentucky, United States, 40202
Sponsors and Collaborators
University of Louisville
Passport Health
Investigators
Principal Investigator: Carmen T Condurache, M.D. University of Louisville
  More Information

Additional Information:
Publications:

Responsible Party: University of Louisville
ClinicalTrials.gov Identifier: NCT01447459     History of Changes
Other Study ID Numbers: Asthma IHOP - 2011
Study First Received: September 27, 2011
Last Updated: May 22, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Louisville:
Asthma
Asthma Education

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on August 18, 2014