Clinical trial NCT06027736: The Effectiveness of Pharmacist-led Educational Model in Patients With Allergic Rhinitis
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)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Allergic Rhinitis
Pharmaceutical Care
Pharmaceutical Services
Keywords: Allergic rhinitis
Pharmacist
Education
Pharmaceutical services
Lead sponsor: Universiti Sains Malaysia
Sponsor class: OTHER
Collaborators: name: Hospital Raja Permaisuri Bainun
First posted: 2023-09-07
Enrollment: 154
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Allergic rhinitis symptom control
timeFrame: 180 days
Secondary outcomes:
measure: Medication adherence to the allergic rhinitis treatment
timeFrame: 180 days
measure: Improvement in quality of life of the allergic rhinitis patients
timeFrame: 180 days
measure: Patients' knowledge of allergic rhinitis
timeFrame: 180 days
Other outcomes:
Locations:
city: Ipoh
country: Malaysia
facility: Raja Permaisuri Bainun Hospital
state: Perak
Study officials:
References:
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