Tailored Pharmacist-led Intervention to Improve Adherence to Budesonide

NCT ID: NCT06080945

Last Updated: 2023-10-12

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 102 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-04
• Study Completion Date: 2024-06-30

Brief 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.

Detailed 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.

Conditions

Asthma in Children

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

Pharmacist-led care group

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.

Group Type: EXPERIMENTAL

pharmacist-led patient-centered medication therapy management

Intervention Type: OTHER

The intervention group will receive a pharmacist-driven discharge counseling on budesonide, an inhaled glucocorticoid, from recruitment, until 12 months.

Usual care group

The control group will receive care as usual

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: OTHER

Eligibility 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.

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 14 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shaoxing Maternity and Child Health Care Hospital

OTHER

Sponsor Role: lead

Responsible Party

Xu Renjie

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Renjie Xu

Role: PRINCIPAL_INVESTIGATOR

Shaoxing Maternity and Child Health Care Hospital

Locations

Shaoxing Maternity and Child Care hospital

Shaoxing, Zhejiang, China

Site Status: RECRUITING

Countries

China

Central Contacts

Renjie Xu, Dr.

Role: CONTACT

xrjsxfby@gmail.com

+86-85081798

Facility Contacts

Renjie Xu, Ph.D

Role: primary

Other Identifiers

ShaoxingMaternityChild

Identifier Type: -

Identifier Source: org_study_id