Effects of Educational Intervention on Long-Term Outcomes of Hospitalized Children With Asthma (IHOP)
The investigators hypothesize that reinforced asthma education improves long-term outcomes in children with asthma.
Specific Aims and Objectives:
- To determine the retention rate of parental knowledge about asthma;
- To evaluate the clinical status, quality of life and healthcare costs of children with asthma following an educational intervention.
|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|
- 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.
- 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.
|Study Start Date:||February 2011|
|Study Completion Date:||October 2012|
|Primary Completion Date:||October 2012 (Final data collection date for primary outcome measure)|
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01447459
|United States, Kentucky|
|Kosair Children's Hospital|
|Louisville, Kentucky, United States, 40202|
|Principal Investigator:||Carmen T Condurache, M.D.||University of Louisville|