Tailored Pharmacist-led Intervention to Improve Adherence to Budesonide

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Tailored Pharmacist-led Intervention to Improve Adherence to Budesonide in Asthmatic Children

Conditions
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Asthma in Children

Intervention / Treatment
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* Other: pharmacist-led patient-centered medication therapy management


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 14 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pharmacist-led care group<br>In addition to usual care, 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. | Other: pharmacist-led patient-centered medication therapy management<br>* The intervention group will receive a pharmacist-driven discharge counseling on budesonide, an inhaled glucocorticoid, from recruitment, until 12 months.<br>|
| No Intervention: Usual care group<br>The control group will receive care as usual | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Spirometry Measurements | 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. | during the intervention (up to 1 year) | 
| Medication adherence assessment | 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). | during the intervention (up to 1 year) |