NCT06027736

The Effectiveness of Pharmacist-led Educational Model in Patients With Allergic Rhinitis

The Effectiveness of Pharmacist-led Educational Model in Patients With Allergic Rhinitis in a Malaysian Tertiary Hospital: A Randomised Control Trial Protocol (AR-PRISE RCT)

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 154 (estimated)
• Sponsor: Dr. Chee Ping Chong · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Allergic rhinitis is a chronic respiratory disorder affecting patients' quality of life and work performance. Pharmacists are identified as suitable professionals to deliver patient education and pharmaceutical care in managing allergic rhinitis (AR) patients. Local clinical practice guidelines in Malaysia are lacking, especially in pharmaceutical care in public healthcare institutions. This study protocol describes a randomised control trial (RCT) that aims to determine the effectiveness of a pharmacist-led educational model in managing AR (AR-PRISE Model) compared to standard pharmaceutical care. The AR-PRISE model delivers patient educational material (video) and an algorithm for pharmaceutical care.

Detailed description

This is a six-month, single-centre, prospective, randomised, two-arm, and parallel-group controlled trial. This trial recruits patients attending a tertiary hospital's otorhinolaryngology outpatient clinics. The participants are randomised into the control or intervention groups at 1:1 using permuted block randomisation. Each group required 77 participants. The control group will receive standard pharmaceutical care. The intervention group will receive pharmacist-led education according to the AR-PRISE model. Both groups will be assessed for the middle turbinate endoscopy findings, disease severity, knowledge level, symptom control, medication adherence, and quality of life (QoL) at baseline and end-of-study follow-up (Day 180±7). Depending on the feasibility at Day 60±7 and 120±7, they will be followed up virtually or face-to-face. During the intermediate follow-up, the participants will be assessed for symptom control, medication adherence, and QoL. The intention-to-treat analysis will include all participants assigned to each group. An Independent T-Test compares the mean difference in knowledge level between the two groups. A two-way repeated measure ANOVA analysis will be employed to determine between-group differences for scores of symptom control, adherence rate, and QoL. A one-way repeated measure ANOVA will be performed for within-group analysis. A P-value \< 0.05 is considered statistically significant.

Conditions

• Allergic Rhinitis
• Pharmaceutical Care
• Pharmaceutical Services

Interventions

Type	Name	Description
OTHER	pharmacist-led education	A patient education protocol and an algorithm of pharmaceutical care in managing allergic rhinitis.

Timeline

• Start date: 2023-06-01
• Primary completion: 2024-06-01
• Completion: 2024-12-01
• First posted: 2023-09-07
• Last updated: 2023-09-07

Locations

1 site across 1 country: Malaysia