Pharmacist-led intervention to help children with asthma take their medication
Tailored Pharmacist-led Intervention to Improve Adherence to Budesonide in Asthmatic Children
This study tests if getting extra help from a pharmacist can help children with asthma take their budesonide medication correctly and improve their lung function.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 102 (estimated) |
| Ages | 6 Years to 14 Years |
| Sex | All |
| Sponsor | Shaoxing Maternity and Child Health Care Hospital Academic / other |
| Locations | 1 site (Shaoxing, Zhejiang) |
| Trial ID | NCT06080945 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of a pharmacist-led patient-centered medication therapy management program aimed at improving adherence to budesonide among children aged 6 to 14 with asthma. The study involves a randomized controlled design where participants are assigned to either an intervention group receiving enhanced counseling from a pharmacist or a control group receiving standard care. The intervention includes personalized education, medication management, and follow-up support to ensure proper use of budesonide. The primary outcomes measured are lung function through spirometry and adherence to medication regimens over a 12-month period.
Who should consider this trial
Good fit: Ideal candidates for this study are children aged 6 to 14 diagnosed with asthma who have dysfunctional lung function and have not previously undergone respiratory rehabilitation.
Not a fit: Patients experiencing acute asthma exacerbations or those with co-existing respiratory or cardiovascular diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly improve asthma control and medication adherence in children, leading to better health outcomes.
How similar studies have performed: Other studies have shown success with pharmacist-led interventions in improving medication adherence and asthma management, indicating a promising approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 6-14 years-of-age * Met the diagnostic criteria described by the "Recommendations for Standardized Diagnosis and Treatment of Bronchial Asthma in Children (2020 Edition)" * Dysfunctional lung function with a positive provocation test * No previous respiratory rehabilitation treatment * The parents' written informed consent. Exclusion Criteria: * Acute exacerbation of asthma * The co-existence of other respiratory system diseases (such as bronchopneumonia and bronchopulmonary dysplasia), cardiovascular system diseases (myocarditis and congenital heart disease), motor nervous system diseases * The presence of mental disorders or the patient had psychological abnormalities and could not cooperate.
Where this trial is running
Shaoxing, Zhejiang
- Shaoxing Maternity and Child Care hospital — Shaoxing, Zhejiang, China (Recruiting)
Study contacts
- Principal investigator: Renjie Xu — Shaoxing Maternity and Child Health Care Hospital
- Study coordinator: Renjie Xu, Dr.
- Email: xrjsxfby@gmail.com
- Phone: +86-85081798
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.