Tailored Pharmacist-led Intervention to Improve Adherence to Budesonide in Asthmatic Children
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 102
- 试验地点
- 1
- 主要终点
- Medication adherence assessment
研究概览
简要总结
Gaining control of asthma can be especially difficult during childhood as children undergo a variety of biological, developmental, and psychosocial changes. This study was designed to evaluate the impact of a pharmacist-led patient-centered medication therapy management trial on asthma and medication adherence among children receiving budesonide at a tertiary hospital in Shaoxing, China. In this randomised controlled trial, one hundred and two children, with asthma, from 6 to 14 age, will be recruited and randomised to an intervention group or a control group. The intervention group will receive a pharmacist-driven discharge counseling on budesonide, an inhaled glucocorticoid, from recruitment, until 12 months. The control group will receive care as usual. The main outcomes were spirometry measurements and medication adherence estimation.
详细描述
The patient in the intervention group received pharmacist-led multidisciplinary care. The multidisciplinary team consists of a physician, a pharmacist and a nurse. To ensure the uniformity of the material provided during counseling sessions, all professionals attended training before beginning to work with patients. Patients in the control group were given the hospital's standard of care discharge counseling on budesonide, whereas patients in the intervention group were given both the standard of care counseling and a pharmacist-driven discharge counseling on budesonide. A pharmacist first spoke with the parents to obtain comprehensive medical, familial, and social histories. After personalized pharmacogenetic testing, a pamphlet with instructions on how to take their medications was given to each parent . Then, they were provided with an educational pamphlet during discharge, Parents signed in the educational pamphlet to confirm that they had received the medication information . The pamphlet contained general advice on lifestyle changes while taking budesonide, how to handle gastrointestinal reactions if it occurs, general safety measures, and details on over-the-counter medications that might interact with inhaled corticosteroid (ICS). The pamphlet included details on how often to take the medication, management about missing doses, how to store it, how food and medications interact with it, and any other information relevant to budesonide. Pharmacists explained the content of the pamphlet to the parents, and answered any question related to the drug. All parents in the pharmacist-led group got phone calls from pharmacists as part of the routine clinical follow-up to evaluate their use of ICS, to clarify any uncertainties, and to contact their doctors as necessary to address any problems that were discovered. At intervals of one to three months, in conjunction with the dates for clinical follow-up appointments or medication refills, the parents were informed of planned follow-up conversations over the phone or in person. Each visit included a planned, one-on-one education session on medications.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 6 Years 至 14 Years(Child)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Medication adherence assessment
时间窗: during the intervention (up to 1 year)
Previous studies show medication adherence estimation and differentiation scale (MEDS) has proven good reliability and validity . The MEDS version had 16 items, and each "Never" response received a score of "1," "Rarely" received a score of "2," "Sometimes" received a score of "3," "Often" received a score of "4", and "Always" received a score of "5". Consequently, a patient could receive an overall number between 16 (perfectly adherent) and 80 (completely non-adherent).
Spirometry Measurements
时间窗: during the intervention (up to 1 year)
Spirometry measurements was measured using a lung function tester (JAEGER, Germany). Measurement indicators were shown as forced expiratory volume in one second (FEV1). The percentage (%) of the actual value to the expected value was used for data analysis.
次要结局
未报告次要终点
研究者
Xu Renjie
Principal Investigator
Shaoxing Maternity and Child Health Care Hospital
