The Effectiveness of Pharmacist-led Educational Model in Patients With

Status Recruiting

Clinical Trial 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.

Clinical Trial 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

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT06027736
Study type	Interventional
Source	Universiti Sains Malaysia
Contact	Chii-chii Chew
Phone	+605 208 5148
Email	chiichii.crcperak@gmail.com
Status	Recruiting
Phase	N/A
Start date	June 1, 2023
Completion date	December 2024

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT05080322` - Efficacy and Safety of On-demand and Continuous Administration of Nasal Spray in the Treatment of Allergic Rhinitis	Phase 4
Recruiting	`NCT06028490` - A Study of IL4Rα Monoclonal Antibody in Patients With Uncontrolled Seasonal Allergic Rhinitis.	Phase 2
Completed	`NCT04388358` - Traditional Chinese Medicine for the Treatment of Perennial Allergic Rhinitis on Gut Microbiota and Immune-modulation	N/A
Recruiting	`NCT04202263` - Assessment of Suppression of Cutaneous Allergic Responses and Pruritis by Topical Minocycline	Phase 2
Completed	`NCT04078009` - Standardising Nasal Allergen Challenge in Adult With Hay Fever	N/A
Completed	`NCT03644680` - Changes in Adaptive Immune Responses and Effector Cell Responses Upon Nasal Allergen Exposure - a Pilot Study	N/A
Completed	`NCT04541004` - Adolescent Mite Allergy Safety Evaluation	Phase 3
Recruiting	`NCT05378594` - HDM and Silver Birch NAC Standardisation	N/A
Not yet recruiting	`NCT05684380` - Efficacy and Safety of MAZ-101 in the Treatment of Persistent Allergic Rhinitis (PER)	Phase 3
Not yet recruiting	`NCT01014325` - Safety and Efficacy Study With Allergen Extracts of House Dust Mites for Specific Sublingual Immunotherapy	Phase 3
Completed	`NCT02943720` - ATIBAR - Efficacy and Safety of Two Doses of AllerT in Patients Allergic to Birch Pollen	Phase 2
Completed	`NCT02910401` - Clinical Response to Rhinovirus Challenge	Phase 2
Completed	`NCT02556801` - Efficacy and Safety of SUBLIVAC Phleum for Immunotherapy of Grass Pollen-Allergy	Phase 2
Not yet recruiting	`NCT02233426` - Effect of Hypertonic Solutions on Allergic Rhinitis Patients	N/A
Completed	`NCT02352168` - Airway Inflammation in Children With Allergic Rhinitis and Intervention	N/A
Completed	`NCT01946035` - Alpha-Blockers in Allergic Rhinitis (MAN 01)	Phase 4
Completed	`NCT01918956` - PURETHAL Birch RUSH Study	Phase 4
Completed	`NCT01682070` - SUBLIVAC FIX Phleum Pratense DT/DRF	Phase 2
Recruiting	`NCT01454492` - The Relationship Between Allergic Rhinitis and Geographic Tongue	N/A
Completed	`NCT01439815` - An Allergen BioCube (ABC) Study Evaluating the Efficacy of Fluticasone Propionate Nasal Spray Compared to Placebo	Phase 4

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms