Tailored Pharmacist-led Intervention to Improve Adherence to Budesonide

NCT06080945 | Unknown

• 1 other identifier: ShaoxingMaternityChild
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

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.

Conditions

Asthma in Children

Outcome Measures

Primary Outcomes (2)

• 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)

Study Arms (2)

Pharmacist-led care group

EXPERIMENTAL

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

Usual care group

NO INTERVENTION

The control group will receive care as usual

Interventions

pharmacist-led patient-centered medication therapy management OTHER

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

Pharmacist-led care group

Eligibility Criteria

• Age: 6 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shaoxing Maternity and Child Health Care Hospital: lead

Study Sites (1)

Shaoxing Maternity and Child Care hospital

Shaoxing, Zhejiang, 312000, China

RECRUITING

Study Officials

• Renjie Xu

  Shaoxing Maternity and Child Health Care Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Renjie Xu, Dr.

CONTACT

+86-85081798; xrjsxfby@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 20, 2023
• First Posted: October 12, 2023
• Study Start: January 4, 2022
• Primary Completion: November 8, 2023
• Study Completion: June 30, 2024
• Last Updated: October 12, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)