Tailored Pharmacist-led Intervention to Improve Adherence to Budesonide

Asthma in Children Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06080945
• Other study ID #: ShaoxingMaternityChild
• Status: Recruiting
• Phase: N/A
• Start date: January 4, 2022
• Est. completion date: June 30, 2024

Study information

• Verified date: October 2023
• Source: Shaoxing Maternity and Child Health Care Hospital
• Contact: Renjie Xu, Dr.
• Phone: +86-85081798
• Email: xrjsxfby[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 102
• Est. completion date: June 30, 2024
• Est. primary completion date: November 8, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 14 Years

Eligibility

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.

Related Conditions & MeSH terms

• Asthma in Children

Intervention

Other:
• pharmacist-led patient-centered medication therapy management
The intervention group will receive a pharmacist-driven discharge counseling on budesonide, an inhaled glucocorticoid, from recruitment, until 12 months.

Locations

Country	Name	City	State
China	Shaoxing Maternity and Child Care hospital	Shaoxing	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Shaoxing Maternity and Child Health Care Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)