The Effectiveness of Pharmacist-led Educational Model in Patients With Allergic Rhinitis (AR-PRISE)
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ClinicalTrials.gov Identifier: NCT06027736 |
Recruitment Status :
Recruiting
First Posted : September 7, 2023
Last Update Posted : September 7, 2023
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Allergic Rhinitis Pharmaceutical Care Pharmaceutical Services | Other: pharmacist-led education | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated 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 : | June 1, 2023 |
Estimated Primary Completion Date : | June 2024 |
Estimated Study Completion Date : | December 2024 |
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 |
- Allergic rhinitis symptom control [ Time Frame: 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.
- Medication adherence to the allergic rhinitis treatment [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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.
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Ages Eligible for Study: | 18 Years to 80 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06027736
Contact: Chii-chii Chew | +605 208 5148 | chiichii.crcperak@gmail.com |
Malaysia | |
Raja Permaisuri Bainun Hospital | Recruiting |
Ipoh, Perak, Malaysia | |
Contact: Chii-Chii Chew +605 208 5148 chiichii.crcperak@gmail.com |
Responsible Party: | Dr. Chee Ping Chong, Senior Lecturer, Universiti Sains Malaysia |
ClinicalTrials.gov Identifier: | NCT06027736 |
Other Study ID Numbers: |
NMRR ID-22-01621-I1W (IIR) |
First Posted: | September 7, 2023 Key Record Dates |
Last Update Posted: | September 7, 2023 |
Last Verified: | August 2023 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Allergic rhinitis Pharmacist Education Pharmaceutical services |
Rhinitis Rhinitis, Allergic Respiratory Tract Infections Infections Nose Diseases Respiratory Tract Diseases |
Otorhinolaryngologic Diseases Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Immune System Diseases |