xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT06027736</url>
    </required_header>
    <id_info>
      <org_study_id>NMRR ID-22-01621-I1W (IIR)</org_study_id>
      <nct_id>NCT06027736</nct_id>
    </id_info>
    <brief_title>The Effectiveness of Pharmacist-led Educational Model in Patients With Allergic Rhinitis</brief_title>
    <acronym>AR-PRISE</acronym>
    <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)</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Dr. Chee Ping Chong</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Hospital Raja Permaisuri Bainun</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Universiti Sains Malaysia</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Allergic rhinitis is a chronic respiratory disorder affecting patients' quality of life and&#xD;
        work performance. Pharmacists are identified as suitable professionals to deliver patient&#xD;
        education and pharmaceutical care in managing allergic rhinitis (AR) patients. Local clinical&#xD;
        practice guidelines in Malaysia are lacking, especially in pharmaceutical care in public&#xD;
        healthcare institutions. This study protocol describes a randomised control trial (RCT) that&#xD;
        aims to determine the effectiveness of a pharmacist-led educational model in managing AR&#xD;
        (AR-PRISE Model) compared to standard pharmaceutical care. The AR-PRISE model delivers&#xD;
        patient educational material (video) and an algorithm for pharmaceutical care.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This is a six-month, single-centre, prospective, randomised, two-arm, and parallel-group&#xD;
        controlled trial. This trial recruits patients attending a tertiary hospital's&#xD;
        otorhinolaryngology outpatient clinics. The participants are randomised into the control or&#xD;
        intervention groups at 1:1 using permuted block randomisation. Each group required 77&#xD;
        participants. The control group will receive standard pharmaceutical care. The intervention&#xD;
        group will receive pharmacist-led education according to the AR-PRISE model. Both groups will&#xD;
        be assessed for the middle turbinate endoscopy findings, disease severity, knowledge level,&#xD;
        symptom control, medication adherence, and quality of life (QoL) at baseline and end-of-study&#xD;
        follow-up (Day 180±7). Depending on the feasibility at Day 60±7 and 120±7, they will be&#xD;
        followed up virtually or face-to-face. During the intermediate follow-up, the participants&#xD;
        will be assessed for symptom control, medication adherence, and QoL. The intention-to-treat&#xD;
        analysis will include all participants assigned to each group. An Independent T-Test compares&#xD;
        the mean difference in knowledge level between the two groups. A two-way repeated measure&#xD;
        ANOVA analysis will be employed to determine between-group differences for scores of symptom&#xD;
        control, adherence rate, and QoL. A one-way repeated measure ANOVA will be performed for&#xD;
        within-group analysis. A P-value &lt; 0.05 is considered statistically significant.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">June 1, 2023</start_date>
    <completion_date type="Anticipated">December 2024</completion_date>
    <primary_completion_date type="Anticipated">June 2024</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Health Services Research</primary_purpose>
      <masking>Single (Care Provider)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Allergic rhinitis symptom control</measure>
      <time_frame>180 days</time_frame>
      <description>Patients are free from any symptoms or reduction in the severity of the symptoms of allergic rhinitis.&#xD;
  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.&#xD;
  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.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Medication adherence to the allergic rhinitis treatment</measure>
      <time_frame>180 days</time_frame>
      <description>It involved assessments of the patient's adherence to the intranasal corticosteroid treatment for allergic rhinitis.&#xD;
  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.&#xD;
  The measurement of adherence will be conducted on Day 60 ±7, Day 120 ±7, and Day 180 ±7.&#xD;
  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.&#xD;
  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 &lt; 0.05 is considered statistically significant.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Improvement in quality of life of the allergic rhinitis patients</measure>
      <time_frame>180 days</time_frame>
      <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).&#xD;
  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.&#xD;
  The EQ VAS captures the patients' total present health on a vertical visual analogue scale labelled &quot;The best health you can imagine&quot; (Max score: 100) and &quot;The worst health you can imagine.&quot; (Min score: 0). EQ-5D VAS will be generated in a mean score and standard deviation.&#xD;
  EQ-5D-5L will be measured at baseline, on Day 60 ±7, Day 120 ±7, and Day 180 ±7.&#xD;
  A two-way repeated measure ANOVA analysis will be employed to determine the mean difference between the scores of the control and interventional groups.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Patients' knowledge of allergic rhinitis</measure>
      <time_frame>180 days</time_frame>
      <description>Assessment of the patient's understanding of the symptoms and treatment of allergic rhinitis&#xD;
  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 &quot;yes&quot;, &quot;no&quot;, or &quot;unsure&quot;.&#xD;
  The &quot;yes&quot; answer will be given a score of two; the &quot;no&quot; answer will be given a zero score, and the &quot;not sure&quot; will be given a score of one.&#xD;
  The patients' knowledge will be assessed during the baseline data collection and on Day 180 ±7.&#xD;
  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 &lt; 0.05 is considered statistically significant.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">154</enrollment>
    <condition>Allergic Rhinitis</condition>
    <condition>Pharmaceutical Care</condition>
    <condition>Pharmaceutical Services</condition>
    <arm_group>
      <arm_group_label>Intervention group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>Control group</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>pharmacist-led education</intervention_name>
      <description>A patient education protocol and an algorithm of pharmaceutical care in managing allergic rhinitis.</description>
      <arm_group_label>Intervention group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Inclusion criteria for patients include an aged 18 to 80, Malaysian, diagnosed with&#xD;
               allergic rhinitis, and capable of reading and writing in English or Malay, who attend&#xD;
               the otorhinolaryngology outpatient clinic at Raja Permaisuri Bainun Hospital.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients who are pregnant, lactating, or have a comorbid diagnosis of chronic&#xD;
               rhinosinusitis will be excluded.&#xD;
  &#xD;
            -  Patients having psychiatric problems, dementia, terminal illnesses, comorbidities,&#xD;
               post-COVID-19 conditions with symptoms that continue beyond 3 months after being&#xD;
               infected will be excluded.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>80 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Chii-chii Chew</last_name>
      <phone>+605 208 5148</phone>
      <email>chiichii.crcperak@gmail.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Raja Permaisuri Bainun Hospital</name>
        <address>
          <city>Ipoh</city>
          <state>Perak</state>
          <country>Malaysia</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Chii-Chii Chew</last_name>
        <phone>+605 208 5148</phone>
        <email>chiichii.crcperak@gmail.com</email>
      </contact>
    </location>
    <location_countries>
      <country>Malaysia</country>
    </location_countries>
    <results_reference>
      <citation>Chew CC, Chang CT, Lim XJ, Yong WY, George D, Letchumanan P, Rajan P, Chong CP. The management of allergic rhinitis by pharmacists in public services: a proposed PhaRmacISt-led Education Model (AR-PRISE). J Pharm Policy Pract. 2022 Nov 8;15(1):80. doi: 10.1186/s40545-022-00477-1.</citation>
      <PMID>36348443</PMID>
    </results_reference>
    <results_reference>
      <citation>Cvetkovski B, Kritikos V, Tan R, Yan K, Azzi E, Srour P, Bosnic-Anticevich S. A qualitative investigation of the allergic rhinitis network from the perspective of the patient. NPJ Prim Care Respir Med. 2019 Sep 19;29(1):35. doi: 10.1038/s41533-019-0147-5.</citation>
      <PMID>31537804</PMID>
    </results_reference>
    <results_reference>
      <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.</citation>
      <PMID>15005760</PMID>
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    <results_reference>
      <citation>Bosnic-Anticevich S, Costa E, Menditto E, Lourenco O, Novellino E, Bialek S, Briedis V, Buonaiuto R, Chrystyn H, Cvetkovski B, Di Capua S, Kritikos V, Mair A, Orlando V, Paulino E, Salimaki J, Soderlund R, Tan R, Williams DM, Wroczynski P, Agache I, Ansotegui IJ, Anto JM, Bedbrook A, Bachert C, Bewick M, Bindslev-Jensen C, Brozek JL, Canonica GW, Cardona V, Carr W, Casale TB, Chavannes NH, Correia de Sousa J, Cruz AA, Czarlewski W, De Carlo G, Demoly P, Devillier P, Dykewicz MS, Gaga M, El-Gamal Y, Fonseca J, Fokkens WJ, Guzman MA, Haahtela T, Hellings PW, Illario M, Ivancevich JC, Just J, Kaidashev I, Khaitov M, Khaltaev N, Keil T, Klimek L, Kowalski ML, Kuna P, Kvedariene V, Larenas-Linnemann DE, Laune D, Le LTT, Lodrup Carlsen KC, Mahboub B, Maier D, Malva J, Manning PJ, Morais-Almeida M, Mosges R, Mullol J, Munter L, Murray R, Naclerio R, Namazova-Baranova L, Nekam K, Nyembue TD, Okubo K, O'Hehir RE, Ohta K, Okamoto Y, Onorato GL, Palkonen S, Panzner P, Papadopoulos NG, Park HS, Pawankar R, Pfaar O, Phillips J, Plavec D, Popov TA, Potter PC, Prokopakis EP, Roller-Wirnsberger RE, Rottem M, Ryan D, Samolinski B, Sanchez-Borges M, Schunemann HJ, Sheikh A, Sisul JC, Somekh D, Stellato C, To T, Todo-Bom AM, Tomazic PV, Toppila-Salmi S, Valero A, Valiulis A, Valovirta E, Ventura MT, Wagenmann M, Wallace D, Waserman S, Wickman M, Yiallouros PK, Yorgancioglu A, Yusuf OM, Zar HJ, Zernotti ME, Zhang L, Zidarn M, Zuberbier T, Bousquet J. ARIA pharmacy 2018 &quot;Allergic rhinitis care pathways for community pharmacy&quot;: AIRWAYS ICPs initiative (European Innovation Partnership on Active and Healthy Ageing, DG CONNECT and DG Sante) POLLAR (Impact of Air POLLution on Asthma and Rhinitis) GARD Demonstration project. Allergy. 2019 Jul;74(7):1219-1236. doi: 10.1111/all.13701. Epub 2019 Apr 30.</citation>
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      <citation>Bousquet JJ, Schunemann HJ, Togias A, Erhola M, Hellings PW, Zuberbier T, Agache I, Ansotegui IJ, Anto JM, Bachert C, Becker S, Bedolla-Barajas M, Bewick M, Bosnic-Anticevich S, Bosse I, Boulet LP, Bourrez JM, Brusselle G, Chavannes N, Costa E, Cruz AA, Czarlewski W, Fokkens WJ, Fonseca JA, Gaga M, Haahtela T, Illario M, Klimek L, Kuna P, Kvedariene V, Le LTT, Larenas-Linnemann D, Laune D, Lourenco OM, Menditto E, Mullol J, Okamoto Y, Papadopoulos N, Pham-Thi N, Picard R, Pinnock H, Roche N, Roller-Wirnsberger RE, Rolland C, Samolinski B, Sheikh A, Toppila-Salmi S, Tsiligianni I, Valiulis A, Valovirta E, Vasankari T, Ventura MT, Walker S, Williams S, Akdis CA, Annesi-Maesano I, Arnavielhe S, Basagana X, Bateman E, Bedbrook A, Bennoor KS, Benveniste S, Bergmann KC, Bialek S, Billo N, Bindslev-Jensen C, Bjermer L, Blain H, Bonini M, Bonniaud P, Bouchard J, Briedis V, Brightling CE, Brozek J, Buhl R, Buonaiuto R, Canonica GW, Cardona V, Carriazo AM, Carr W, Cartier C, Casale T, Cecchi L, Cepeda Sarabia AM, Chkhartishvili E, Chu DK, Cingi C, Colgan E, de Sousa JC, Courbis AL, Custovic A, Cvetkosvki B, D'Amato G, da Silva J, Dantas C, Dokic D, Dauvilliers Y, Dedeu A, De Feo G, Devillier P, Di Capua S, Dykewickz M, Dubakiene R, Ebisawa M, El-Gamal Y, Eller E, Emuzyte R, Farrell J, Fink-Wagner A, Fiocchi A, Fontaine JF, Gemicioglu B, Schmid-Grendelmeir P, Gamkrelidze A, Garcia-Aymerich J, Gomez M, Gonzalez Diaz S, Gotua M, Guldemond NA, Guzman MA, Hajjam J, O'B Hourihane J, Humbert M, Iaccarino G, Ierodiakonou D, Illario M, Ivancevich JC, Joos G, Jung KS, Jutel M, Kaidashev I, Kalayci O, Kardas P, Keil T, Khaitov M, Khaltaev N, Kleine-Tebbe J, Kowalski ML, Kritikos V, Kull I, Leonardini L, Lieberman P, Lipworth B, Lodrup Carlsen KC, Loureiro CC, Louis R, Mair A, Marien G, Mahboub B, Malva J, Manning P, De Manuel Keenoy E, Marshall GD, Masjedi MR, Maspero JF, Mathieu-Dupas E, Matricardi PM, Melen E, Melo-Gomes E, Meltzer EO, Menditto E, Mercier J, Miculinic N, Mihaltan F, Milenkovic B, Moda G, Mogica-Martinez MD, Mohammad Y, Montefort S, Monti R, Morais-Almeida M, Mosges R, Munter L, Muraro A, Murray R, Naclerio R, Napoli L, Namazova-Baranova L, Neffen H, Nekam K, Neou A, Novellino E, Nyembue D, O'Hehir R, Ohta K, Okubo K, Onorato G, Ouedraogo S, Pali-Scholl I, Palkonen S, Panzner P, Park HS, Pepin JL, Pereira AM, Pfaar O, Paulino E, Phillips J, Picard R, Plavec D, Popov TA, Portejoie F, Price D, Prokopakis EP, Pugin B, Raciborski F, Rajabian-Soderlund R, Reitsma S, Rodo X, Romano A, Rosario N, Rottem M, Ryan D, Salimaki J, Sanchez-Borges MM, Sisul JC, Sole D, Somekh D, Sooronbaev T, Sova M, Spranger O, Stellato C, Stelmach R, Suppli Ulrik C, Thibaudon M, To T, Todo-Bom A, Tomazic PV, Valero AA, Valenta R, Valentin-Rostan M, van der Kleij R, Vandenplas O, Vezzani G, Viart F, Viegi G, Wallace D, Wagenmann M, Wang Y, Waserman S, Wickman M, Williams DM, Wong G, Wroczynski P, Yiallouros PK, Yorgancioglu A, Yusuf OM, Zar HJ, Zeng S, Zernotti M, Zhang L, Zhong NS, Zidarn M; ARIA Study Group; MASK Study Group. Next-generation ARIA care pathways for rhinitis and asthma: a model for multimorbid chronic diseases. Clin Transl Allergy. 2019 Sep 9;9:44. doi: 10.1186/s13601-019-0279-2. eCollection 2019.</citation>
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      <PMID>32429362</PMID>
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      <citation>Jose J, Cvetkovski B, Kritikos V, Tan R, Bosnic-Anticevich S, Lourenco O. Interventions Delivered in the Community Pharmacy to Manage Allergic Rhinitis- A Systematic Review of the Literature. Pharmacy (Basel). 2020 May 6;8(2):80. doi: 10.3390/pharmacy8020080.</citation>
      <PMID>32384674</PMID>
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      <citation>Arsoy G, Varis A, Saloumi LM, Abdi A, Basgut B. Insights on Allergic Rhinitis Management from a Northern Cyprus Perspective and Evaluation of the Impact of Pharmacist-Led Educational Intervention on Patients' Outcomes. Medicina (Kaunas). 2018 Nov 7;54(5):83. doi: 10.3390/medicina54050083.</citation>
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    <results_reference>
      <citation>Bousquet J, Schunemann HJ, Togias A, Bachert C, Erhola M, Hellings PW, Klimek L, Pfaar O, Wallace D, Ansotegui I, Agache I, Bedbrook A, Bergmann KC, Bewick M, Bonniaud P, Bosnic-Anticevich S, Bosse I, Bouchard J, Boulet LP, Brozek J, Brusselle G, Calderon MA, Canonica WG, Caraballo L, Cardona V, Casale T, Cecchi L, Chu DK, Costa EM, Cruz AA, Czarlewski W, D'Amato G, Devillier P, Dykewicz M, Ebisawa M, Fauquert JL, Fokkens WJ, Fonseca JA, Fontaine JF, Gemicioglu B, van Wijk RG, Haahtela T, Halken S, Ierodiakonou D, Iinuma T, Ivancevich JC, Jutel M, Kaidashev I, Khaitov M, Kalayci O, Kleine Tebbe J, Kowalski ML, Kuna P, Kvedariene V, La Grutta S, Larenas-Linnemann D, Lau S, Laune D, Le L, Lieberman P, Lodrup Carlsen KC, Lourenco O, Marien G, Carreiro-Martins P, Melen E, Menditto E, Neffen H, Mercier G, Mosgues R, Mullol J, Muraro A, Namazova L, Novellino E, O'Hehir R, Okamoto Y, Ohta K, Park HS, Panzner P, Passalacqua G, Pham-Thi N, Price D, Roberts G, Roche N, Rolland C, Rosario N, Ryan D, Samolinski B, Sanchez-Borges M, Scadding GK, Shamji MH, Sheikh A, Bom AT, Toppila-Salmi S, Tsiligianni I, Valentin-Rostan M, Valiulis A, Valovirta E, Ventura MT, Walker S, Waserman S, Yorgancioglu A, Zuberbier T; Allergic Rhinitis and Its Impact on Asthma Working Group. Next-generation Allergic Rhinitis and Its Impact on Asthma (ARIA) guidelines for allergic rhinitis based on Grading of Recommendations Assessment, Development and Evaluation (GRADE) and real-world evidence. J Allergy Clin Immunol. 2020 Jan;145(1):70-80.e3. doi: 10.1016/j.jaci.2019.06.049. Epub 2019 Oct 15. Erratum In: J Allergy Clin Immunol. 2022 Jun;149(6):2180.</citation>
      <PMID>31627910</PMID>
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    <results_reference>
      <citation>Cvetkovski B, Tan R, Kritikos V, Yan K, Azzi E, Srour P, Bosnic-Anticevich S. A patient-centric analysis to identify key influences in allergic rhinitis management. NPJ Prim Care Respir Med. 2018 Sep 13;28(1):34. doi: 10.1038/s41533-018-0100-z.</citation>
      <PMID>30213945</PMID>
    </results_reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 23, 2023</study_first_submitted>
    <study_first_submitted_qc>August 30, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 7, 2023</study_first_posted>
    <last_update_submitted>August 30, 2023</last_update_submitted>
    <last_update_submitted_qc>August 30, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 7, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor-Investigator</responsible_party_type>
      <investigator_affiliation>Universiti Sains Malaysia</investigator_affiliation>
      <investigator_full_name>Dr. Chee Ping Chong</investigator_full_name>
      <investigator_title>Senior Lecturer</investigator_title>
    </responsible_party>
    <keyword>Allergic rhinitis</keyword>
    <keyword>Pharmacist</keyword>
    <keyword>Education</keyword>
    <keyword>Pharmaceutical services</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Rhinitis</mesh_term>
      <mesh_term>Rhinitis, Allergic</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT06027736
  org study id: NMRR ID-22-01621-I1W (IIR)
  nct id: NCT06027736
  lead sponsor: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  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.
  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.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Health Services Research
  masking: Single (Care Provider)
  measure: Allergic rhinitis symptom control
  time frame: 180 days
  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.
  measure: Medication adherence to the allergic rhinitis treatment
  time frame: 180 days
  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.
  measure: Improvement in quality of life of the allergic rhinitis patients
  time frame: 180 days
  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.
  measure: Patients' knowledge of allergic rhinitis
  time frame: 180 days
  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.
  arm group label: Intervention group
  arm group type: Experimental
  arm group label: Control group
  arm group type: No Intervention
  intervention type: Other
  intervention name: pharmacist-led education
  description: A patient education protocol and an algorithm of pharmaceutical care in managing allergic rhinitis.
  arm group label: Intervention group
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 80 Years
  healthy volunteers: No
  last name: Chii-chii Chew
  phone: +605 208 5148
  email: chiichii.crcperak@gmail.com
  facility: 
  status: Recruiting
  contact: 
  country: Malaysia
  citation: Chew CC, Chang CT, Lim XJ, Yong WY, George D, Letchumanan P, Rajan P, Chong CP. The management of allergic rhinitis by pharmacists in public services: a proposed PhaRmacISt-led Education Model (AR-PRISE). J Pharm Policy Pract. 2022 Nov 8;15(1):80. doi: 10.1186/s40545-022-00477-1.
  PMID: 36348443
  citation: Cvetkovski B, Kritikos V, Tan R, Yan K, Azzi E, Srour P, Bosnic-Anticevich S. A qualitative investigation of the allergic rhinitis network from the perspective of the patient. NPJ Prim Care Respir Med. 2019 Sep 19;29(1):35. doi: 10.1038/s41533-019-0147-5.
  PMID: 31537804
  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.
  PMID: 15005760
  citation: Bosnic-Anticevich S, Costa E, Menditto E, Lourenco O, Novellino E, Bialek S, Briedis V, Buonaiuto R, Chrystyn H, Cvetkovski B, Di Capua S, Kritikos V, Mair A, Orlando V, Paulino E, Salimaki J, Soderlund R, Tan R, Williams DM, Wroczynski P, Agache I, Ansotegui IJ, Anto JM, Bedbrook A, Bachert C, Bewick M, Bindslev-Jensen C, Brozek JL, Canonica GW, Cardona V, Carr W, Casale TB, Chavannes NH, Correia de Sousa J, Cruz AA, Czarlewski W, De Carlo G, Demoly P, Devillier P, Dykewicz MS, Gaga M, El-Gamal Y, Fonseca J, Fokkens WJ, Guzman MA, Haahtela T, Hellings PW, Illario M, Ivancevich JC, Just J, Kaidashev I, Khaitov M, Khaltaev N, Keil T, Klimek L, Kowalski ML, Kuna P, Kvedariene V, Larenas-Linnemann DE, Laune D, Le LTT, Lodrup Carlsen KC, Mahboub B, Maier D, Malva J, Manning PJ, Morais-Almeida M, Mosges R, Mullol J, Munter L, Murray R, Naclerio R, Namazova-Baranova L, Nekam K, Nyembue TD, Okubo K, O'Hehir RE, Ohta K, Okamoto Y, Onorato GL, Palkonen S, Panzner P, Papadopoulos NG, Park HS, Pawankar R, Pfaar O, Phillips J, Plavec D, Popov TA, Potter PC, Prokopakis EP, Roller-Wirnsberger RE, Rottem M, Ryan D, Samolinski B, Sanchez-Borges M, Schunemann HJ, Sheikh A, Sisul JC, Somekh D, Stellato C, To T, Todo-Bom AM, Tomazic PV, Toppila-Salmi S, Valero A, Valiulis A, Valovirta E, Ventura MT, Wagenmann M, Wallace D, Waserman S, Wickman M, Yiallouros PK, Yorgancioglu A, Yusuf OM, Zar HJ, Zernotti ME, Zhang L, Zidarn M, Zuberbier T, Bousquet J. ARIA pharmacy 2018 "Allergic rhinitis care pathways for community pharmacy": AIRWAYS ICPs initiative (European Innovation Partnership on Active and Healthy Ageing, DG CONNECT and DG Sante) POLLAR (Impact of Air POLLution on Asthma and Rhinitis) GARD Demonstration project. Allergy. 2019 Jul;74(7):1219-1236. doi: 10.1111/all.13701. Epub 2019 Apr 30.
  PMID: 30565275
  citation: Bousquet JJ, Schunemann HJ, Togias A, Erhola M, Hellings PW, Zuberbier T, Agache I, Ansotegui IJ, Anto JM, Bachert C, Becker S, Bedolla-Barajas M, Bewick M, Bosnic-Anticevich S, Bosse I, Boulet LP, Bourrez JM, Brusselle G, Chavannes N, Costa E, Cruz AA, Czarlewski W, Fokkens WJ, Fonseca JA, Gaga M, Haahtela T, Illario M, Klimek L, Kuna P, Kvedariene V, Le LTT, Larenas-Linnemann D, Laune D, Lourenco OM, Menditto E, Mullol J, Okamoto Y, Papadopoulos N, Pham-Thi N, Picard R, Pinnock H, Roche N, Roller-Wirnsberger RE, Rolland C, Samolinski B, Sheikh A, Toppila-Salmi S, Tsiligianni I, Valiulis A, Valovirta E, Vasankari T, Ventura MT, Walker S, Williams S, Akdis CA, Annesi-Maesano I, Arnavielhe S, Basagana X, Bateman E, Bedbrook A, Bennoor KS, Benveniste S, Bergmann KC, Bialek S, Billo N, Bindslev-Jensen C, Bjermer L, Blain H, Bonini M, Bonniaud P, Bouchard J, Briedis V, Brightling CE, Brozek J, Buhl R, Buonaiuto R, Canonica GW, Cardona V, Carriazo AM, Carr W, Cartier C, Casale T, Cecchi L, Cepeda Sarabia AM, Chkhartishvili E, Chu DK, Cingi C, Colgan E, de Sousa JC, Courbis AL, Custovic A, Cvetkosvki B, D'Amato G, da Silva J, Dantas C, Dokic D, Dauvilliers Y, Dedeu A, De Feo G, Devillier P, Di Capua S, Dykewickz M, Dubakiene R, Ebisawa M, El-Gamal Y, Eller E, Emuzyte R, Farrell J, Fink-Wagner A, Fiocchi A, Fontaine JF, Gemicioglu B, Schmid-Grendelmeir P, Gamkrelidze A, Garcia-Aymerich J, Gomez M, Gonzalez Diaz S, Gotua M, Guldemond NA, Guzman MA, Hajjam J, O'B Hourihane J, Humbert M, Iaccarino G, Ierodiakonou D, Illario M, Ivancevich JC, Joos G, Jung KS, Jutel M, Kaidashev I, Kalayci O, Kardas P, Keil T, Khaitov M, Khaltaev N, Kleine-Tebbe J, Kowalski ML, Kritikos V, Kull I, Leonardini L, Lieberman P, Lipworth B, Lodrup Carlsen KC, Loureiro CC, Louis R, Mair A, Marien G, Mahboub B, Malva J, Manning P, De Manuel Keenoy E, Marshall GD, Masjedi MR, Maspero JF, Mathieu-Dupas E, Matricardi PM, Melen E, Melo-Gomes E, Meltzer EO, Menditto E, Mercier J, Miculinic N, Mihaltan F, Milenkovic B, Moda G, Mogica-Martinez MD, Mohammad Y, Montefort S, Monti R, Morais-Almeida M, Mosges R, Munter L, Muraro A, Murray R, Naclerio R, Napoli L, Namazova-Baranova L, Neffen H, Nekam K, Neou A, Novellino E, Nyembue D, O'Hehir R, Ohta K, Okubo K, Onorato G, Ouedraogo S, Pali-Scholl I, Palkonen S, Panzner P, Park HS, Pepin JL, Pereira AM, Pfaar O, Paulino E, Phillips J, Picard R, Plavec D, Popov TA, Portejoie F, Price D, Prokopakis EP, Pugin B, Raciborski F, Rajabian-Soderlund R, Reitsma S, Rodo X, Romano A, Rosario N, Rottem M, Ryan D, Salimaki J, Sanchez-Borges MM, Sisul JC, Sole D, Somekh D, Sooronbaev T, Sova M, Spranger O, Stellato C, Stelmach R, Suppli Ulrik C, Thibaudon M, To T, Todo-Bom A, Tomazic PV, Valero AA, Valenta R, Valentin-Rostan M, van der Kleij R, Vandenplas O, Vezzani G, Viart F, Viegi G, Wallace D, Wagenmann M, Wang Y, Waserman S, Wickman M, Williams DM, Wong G, Wroczynski P, Yiallouros PK, Yorgancioglu A, Yusuf OM, Zar HJ, Zeng S, Zernotti M, Zhang L, Zhong NS, Zidarn M; ARIA Study Group; MASK Study Group. Next-generation ARIA care pathways for rhinitis and asthma: a model for multimorbid chronic diseases. Clin Transl Allergy. 2019 Sep 9;9:44. doi: 10.1186/s13601-019-0279-2. eCollection 2019.
  PMID: 31516692
  citation: Lourenco O, Bosnic-Anticevich S, Costa E, Fonseca JA, Menditto E, Cvetkovski B, Kritikos V, Tan R, Bedbrook A, Scheire S, Bachert C, Bialek S, Briedis V, Boussery K, Canonica GW, Haahtela T, Kuna P, Novellino E, Samolinski B, Schunemann HJ, Wallace D, Bousquet J. Managing Allergic Rhinitis in the Pharmacy: An ARIA Guide for Implementation in Practice. Pharmacy (Basel). 2020 May 16;8(2):85. doi: 10.3390/pharmacy8020085.
  PMID: 32429362
  citation: Jose J, Cvetkovski B, Kritikos V, Tan R, Bosnic-Anticevich S, Lourenco O. Interventions Delivered in the Community Pharmacy to Manage Allergic Rhinitis- A Systematic Review of the Literature. Pharmacy (Basel). 2020 May 6;8(2):80. doi: 10.3390/pharmacy8020080.
  PMID: 32384674
  citation: Arsoy G, Varis A, Saloumi LM, Abdi A, Basgut B. Insights on Allergic Rhinitis Management from a Northern Cyprus Perspective and Evaluation of the Impact of Pharmacist-Led Educational Intervention on Patients' Outcomes. Medicina (Kaunas). 2018 Nov 7;54(5):83. doi: 10.3390/medicina54050083.
  PMID: 30405059
  citation: Bousquet J, Schunemann HJ, Togias A, Bachert C, Erhola M, Hellings PW, Klimek L, Pfaar O, Wallace D, Ansotegui I, Agache I, Bedbrook A, Bergmann KC, Bewick M, Bonniaud P, Bosnic-Anticevich S, Bosse I, Bouchard J, Boulet LP, Brozek J, Brusselle G, Calderon MA, Canonica WG, Caraballo L, Cardona V, Casale T, Cecchi L, Chu DK, Costa EM, Cruz AA, Czarlewski W, D'Amato G, Devillier P, Dykewicz M, Ebisawa M, Fauquert JL, Fokkens WJ, Fonseca JA, Fontaine JF, Gemicioglu B, van Wijk RG, Haahtela T, Halken S, Ierodiakonou D, Iinuma T, Ivancevich JC, Jutel M, Kaidashev I, Khaitov M, Kalayci O, Kleine Tebbe J, Kowalski ML, Kuna P, Kvedariene V, La Grutta S, Larenas-Linnemann D, Lau S, Laune D, Le L, Lieberman P, Lodrup Carlsen KC, Lourenco O, Marien G, Carreiro-Martins P, Melen E, Menditto E, Neffen H, Mercier G, Mosgues R, Mullol J, Muraro A, Namazova L, Novellino E, O'Hehir R, Okamoto Y, Ohta K, Park HS, Panzner P, Passalacqua G, Pham-Thi N, Price D, Roberts G, Roche N, Rolland C, Rosario N, Ryan D, Samolinski B, Sanchez-Borges M, Scadding GK, Shamji MH, Sheikh A, Bom AT, Toppila-Salmi S, Tsiligianni I, Valentin-Rostan M, Valiulis A, Valovirta E, Ventura MT, Walker S, Waserman S, Yorgancioglu A, Zuberbier T; Allergic Rhinitis and Its Impact on Asthma Working Group. Next-generation Allergic Rhinitis and Its Impact on Asthma (ARIA) guidelines for allergic rhinitis based on Grading of Recommendations Assessment, Development and Evaluation (GRADE) and real-world evidence. J Allergy Clin Immunol. 2020 Jan;145(1):70-80.e3. doi: 10.1016/j.jaci.2019.06.049. Epub 2019 Oct 15. Erratum In: J Allergy Clin Immunol. 2022 Jun;149(6):2180.
  PMID: 31627910
  citation: Cvetkovski B, Tan R, Kritikos V, Yan K, Azzi E, Srour P, Bosnic-Anticevich S. A patient-centric analysis to identify key influences in allergic rhinitis management. NPJ Prim Care Respir Med. 2018 Sep 13;28(1):34. doi: 10.1038/s41533-018-0100-z.
  PMID: 30213945
  responsible party type: Sponsor-Investigator
  investigator affiliation: Universiti Sains Malaysia
  investigator full name: Dr. Chee Ping Chong
  investigator title: Senior Lecturer
  mesh term: Rhinitis
  mesh term: Rhinitis, Allergic
  sharing ipd: No