Status:
COMPLETED
Promoting Partnership and Improving Self-Management for Children With Persistent Asthma
Lead Sponsor:
University of Rochester
Collaborating Sponsors:
New York State Department of Health
Conditions:
Asthma in Children
Eligibility:
All Genders
7-14 years
Phase:
NA
Brief Summary
The goal of this study is to evaluate a pilot of clinic-based intervention of asthma education. After a scheduled outpatient encounter for well-child care or asthma care has concluded, a pediatric nur...
Detailed Description
Study Design: The investigators propose a clinic-based intervention of asthma education and medication labeling to promote medication knowledge and self-efficacy for adherence among both caregivers a...
Eligibility Criteria
Inclusion
- (all 5 criteria must be met)
- Physician diagnosis of asthma, based on review of medical records.
- Uncontrolled asthma consistent with National Heart, Lung, and Blood Institute (NHLBI) guidelines, with at least 1 of the following based on caregiver report:
- a. If the child is 7-11 years old: i. An average of \>2 days per week with asthma symptoms ii. \>2 days per week with rescue medication use iii. \>2 days per month with nighttime symptoms iv. ≥2 episodes of asthma during the past year that have required systemic corticosteroids b. If the child is 12-14 years old: i. An average of \>2 days per week with asthma symptoms ii. \>2 days per week with rescue medication use iii. Nighttime symptoms 1-3 times per week iv. ≥2 episodes of asthma during the past year that have required systemic
- The child must have a current prescription (within the past year) of an inhaled asthma controller medication, such as an inhaled corticosteroid (ICS), based on review of electronic medical records.
- The child/adolescent is between ≥7 and ≤14 years old.
- The child/adolescent is insured by Medicaid or Medicaid managed care program.
Exclusion
- An inability to speak and understand English. Parents and children with low literacy / health-literacy skills will be eligible, as survey instruments will be administered verbally and educational materials will be designed for low-literacy populations.
- No access to a working phone for follow-up, including care coordinator calls and the final follow-up survey.
- Another significant medical condition identified in the child's medical record that could interfere with assessment of asthma control, including Cystic Fibrosis, congenital heart disease, or other chronic pulmonary disease.
- A diagnosed developmental condition (e.g. Autism spectrum disorder or significant developmental delay) identified in the child's medical record that could impact the transition of responsibility for inhaled asthma medications from caregiver to child.
- If the child or family is currently enrolled in a study conducted by The Preventive Care Program for Urban Children with Asthma (led by Dr. Jill Halterman).
Key Trial Info
Start Date :
June 7 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2019
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT03390556
Start Date
June 7 2018
End Date
June 30 2019
Last Update
July 23 2019
Active Locations (1)
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1
University of Rochester Medical Center
Rochester, New York, United States, 14642