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

Sponsor

Dr. Chee Ping Chong (Other)

Overall Status

Recruiting

CT.gov ID

NCT06027736

Collaborator

Hospital Raja Permaisuri Bainun (Other)

154

Enrollment

Location

Arms

Anticipated Duration (Months)

8.5

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Allergic Rhinitis Pharmaceutical Care Pharmaceutical Services	Other: pharmacist-led education	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

154 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Care Provider)

Primary Purpose:

Health Services Research

Official Title:

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)

Actual Study Start Date :

Jun 1, 2023

Anticipated Primary Completion Date :

Jun 1, 2024

Anticipated Study Completion Date :

Dec 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intervention group	Other: pharmacist-led education A patient education protocol and an algorithm of pharmaceutical care in managing allergic rhinitis.
No Intervention: Control group

Arm

Intervention/Treatment

Experimental: Intervention group

Other: pharmacist-led education

A patient education protocol and an algorithm of pharmaceutical care in managing allergic rhinitis.

No Intervention: Control group

Outcome Measures

Primary Outcome Measures

Allergic rhinitis symptom control [180 days]
Patients are free from any symptoms or reduction in the severity of the symptoms of allergic rhinitis. Total Nasal Symptom Score (TNSS) tool will be used for patients to self-rate their nasal symptoms, including nasal obstruction, itching, sneezing, secretion, runny nose, and sleep difficulty, on a 4-point Likert scale ranging from 0 (no symptom) to 3 (severe symptom). The scores will be summed; a higher score indicates the more severe the symptoms are. The measurement of nasal symptoms will be conducted at baseline, on Day 60 ±7, Day 120 ±7, and Day 180 ±7. The outcomes will be generated as a mean and standard deviation. A two-way repeated measure ANOVA analysis will be employed to determine the mean difference between the scores of the control group and the interventional group to determine the overall effectiveness of the intervention.

Secondary Outcome Measures

Medication adherence to the allergic rhinitis treatment [180 days]
It involved assessments of the patient's adherence to the intranasal corticosteroid treatment for allergic rhinitis. Medication adherence is measured by using a self-developed diary card. Patients will be asked to record their medication adherence levels on their daily use of intranasal corticosteroids. The measurement of adherence will be conducted on Day 60 ±7, Day 120 ±7, and Day 180 ±7. The estimation of the number of days that the patients declare that they are taking the medication will be summed for each measurement. A mean number of days of intranasal corticosteroid usage will be generated. A two-way repeated measure ANOVA analysis will be used to compare the between-group differences for the mean number of days of intranasal corticosteroid usage. A one-way repeated measure ANOVA analysis will be performed to determine within the group analysis. A value of P < 0.05 is considered statistically significant.
Improvement in quality of life of the allergic rhinitis patients [180 days]
The 5-level EQ-5D version (EQ-5D-5L) questionnaire to assess the quality of life. It comprises a descriptive system and the EQ VAS (Visual Analogue Scale). The descriptive system comprises 5 dimensions, each with 5 response levels: no difficulties, slight, moderate, severe, and extreme problems. The outcome will be presented in a mean score and standard deviation in EQ-5D-5L utility index scores using the EQ-5D-5L index calculator for Malaysia. The EQ VAS captures the patients' total present health on a vertical visual analogue scale labelled "The best health you can imagine" (Max score: 100) and "The worst health you can imagine." (Min score: 0). EQ-5D VAS will be generated in a mean score and standard deviation. EQ-5D-5L will be measured at baseline, on Day 60 ±7, Day 120 ±7, and Day 180 ±7. A two-way repeated measure ANOVA analysis will be employed to determine the mean difference between the scores of the control and interventional groups.
Patients' knowledge of allergic rhinitis [180 days]
Assessment of the patient's understanding of the symptoms and treatment of allergic rhinitis A self-administered questionnaire evaluating the knowledge on patients' understanding of intranasal corticosteroids. It consists of four items, and patients are required to answer each item by marking the responses as "yes", "no", or "unsure". The "yes" answer will be given a score of two; the "no" answer will be given a zero score, and the "not sure" will be given a score of one. The patients' knowledge will be assessed during the baseline data collection and on Day 180 ±7. The outcome will be presented in the mean score and standard deviation. Each question will be analysed separately. Between-group comparisons will be analysed using a T-test to compare the mean score difference between the two groups. Meanwhile, within-group comparisons will be analysed using the Paired T-test. A value of P < 0.05 is considered statistically significant.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Inclusion criteria for patients include an aged 18 to 80, Malaysian, diagnosed with allergic rhinitis, and capable of reading and writing in English or Malay, who attend the otorhinolaryngology outpatient clinic at Raja Permaisuri Bainun Hospital.

Exclusion Criteria:

Patients who are pregnant, lactating, or have a comorbid diagnosis of chronic rhinosinusitis will be excluded.
Patients having psychiatric problems, dementia, terminal illnesses, comorbidities, post-COVID-19 conditions with symptoms that continue beyond 3 months after being infected will be excluded.