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

Primary Purpose

Allergic Rhinitis, Pharmaceutical Care, Pharmaceutical Services

Status
Recruiting
Phase
Not Applicable
Locations
Malaysia
Study Type
Interventional
Intervention
pharmacist-led education
Sponsored by
Dr. Chee Ping Chong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Allergic Rhinitis focused on measuring Allergic rhinitis, Pharmacist, Education, Pharmaceutical services

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Raja Permaisuri Bainun HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention group

Control group

Arm Description

Outcomes

Primary Outcome Measures

Allergic rhinitis symptom control
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
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
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
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.

Full Information

First Posted
August 23, 2023
Last Updated
August 30, 2023
Sponsor
Dr. Chee Ping Chong
Collaborators
Hospital Raja Permaisuri Bainun
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1. Study Identification

Unique Protocol Identification Number
NCT06027736
Brief Title
The Effectiveness of Pharmacist-led Educational Model in Patients With Allergic Rhinitis
Acronym
AR-PRISE
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

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2023 (Actual)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Dr. Chee Ping Chong
Collaborators
Hospital Raja Permaisuri Bainun

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Allergic Rhinitis, Pharmaceutical Care, Pharmaceutical Services
Keywords
Allergic rhinitis, Pharmacist, Education, Pharmaceutical services

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care Provider
Allocation
Randomized
Enrollment
154 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention group
Arm Type
Experimental
Arm Title
Control group
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
pharmacist-led education
Intervention Description
A patient education protocol and an algorithm of pharmaceutical care in managing allergic rhinitis.
Primary Outcome Measure Information:
Title
Allergic rhinitis symptom control
Description
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.
Time Frame
180 days
Secondary Outcome Measure Information:
Title
Medication adherence to the allergic rhinitis treatment
Description
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.
Time Frame
180 days
Title
Improvement in quality of life of the allergic rhinitis patients
Description
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.
Time Frame
180 days
Title
Patients' knowledge of allergic rhinitis
Description
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.
Time Frame
180 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chii-chii Chew
Phone
+605 208 5148
Email
chiichii.crcperak@gmail.com
Facility Information:
Facility Name
Raja Permaisuri Bainun Hospital
City
Ipoh
State/Province
Perak
Country
Malaysia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chii-Chii Chew
Phone
+605 208 5148
Email
chiichii.crcperak@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
36348443
Citation
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15005760
Citation
Members of the Workshops. ARIA in the pharmacy: management of allergic rhinitis symptoms in the pharmacy. Allergic rhinitis and its impact on asthma. Allergy. 2004 Apr;59(4):373-87. doi: 10.1111/j.1398-9995.2003.00468.x. No abstract available.
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The Effectiveness of Pharmacist-led Educational Model in Patients With Allergic Rhinitis

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