<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/NCT03254745</url>
  </required_header>
  <id_info>
    <org_study_id>PACT1</org_study_id>
    <nct_id>NCT03254745</nct_id>
  </id_info>
  <brief_title>Evaluation of Pharmacist's Intervention in Improving Treatment Outcomes of Rheumatoid Arthritis: A Randomized Controlled Trial</brief_title>
  <acronym>PACTRA</acronym>
  <official_title>Evaluation of Pharmacist's Intervention in Improving Treatment Outcomes of Rheumatoid Arthritis Patients in Karachi, Pakistan: The Pharmacist Assisted Care Trial for Rheumatoid Arthritis Patients (PACTRA)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universiti Sains Malaysia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </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>
      Rheumatoid arthritis is an auto-immune disorders that mainly affects the joints. It may also&#xD;
      affect other organs of the body such as skin, eyes, lungs and heart. The immune system of the&#xD;
      body attacks the lining of the joint that results in erosion and joint deformity. This&#xD;
      condition if untreated may lead to disability. RA is managed by medications known as disease&#xD;
      modifying anti rheumatic drugs (DMARDs) as well as physical therapy. Dietary and lifestyle&#xD;
      modification may also ease the condition.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      One of the major problems in managing RA is adherence to rehabilitation and medication.&#xD;
      Studies report low adherence to medication among patients of RA. Certain barriers to&#xD;
      rehabilitation also exists which may include exhaustive treatment attendance, time management&#xD;
      and direct costs. Patient intentionally make decisions of non adherence to their prescribed&#xD;
      rehabilitation schedule and medication regimen. This may be due to suffering from adverse&#xD;
      drug reactions (ADRs) of medications, excessive pain arising from physical therapy and/or&#xD;
      out-of-pocket costs.&#xD;
&#xD;
      Pharmacists have the potential to improve the patient's clinical, humanistic and economic&#xD;
      outcomes in rheumatoid arthritis by providing pharmaceutical care. This can be executed by:&#xD;
&#xD;
        1. Resolving drug related problems and managing drug therapy&#xD;
&#xD;
        2. Management of modifiable risk factors such as weight&#xD;
&#xD;
        3. Recommending dietary and lifestyle changes&#xD;
&#xD;
        4. Providing patient counseling, disease education and medication advice&#xD;
&#xD;
        5. Reducing the out-of-pocket costs&#xD;
&#xD;
        6. Improve overall well being and quality of life&#xD;
&#xD;
      Evidence from the past indicates a varying prevalence of RA in Pakistan. Figures for&#xD;
      prevalence of RA varied geographically as literature reported a prevalence of 0.142% to 5.5%&#xD;
      in the southern and northern region of Pakistan respectively. Recently, a study conducted in&#xD;
      a tertiary care unit in the city of Karachi located in southern region reported a figure of&#xD;
      633 (12.9%) for RA patients out of total 4900 patients who visited rheumatology clinic in the&#xD;
      hospital. It highlighted that disease burden in this region has dramatically increased.&#xD;
&#xD;
      Most Pakistani patients lack adequate disease knowledge and awareness regarding RA. Moreover,&#xD;
      patients in Pakistan have to pay direct medical cost in most of the cases. In the past,&#xD;
      studies have highlighted that Pakistani patients view costs per session and treatment&#xD;
      attendance as major barriers to undergo physical therapy sessions for rheumatological&#xD;
      disorders.&#xD;
&#xD;
      There is a dearth of literature reported on pharmacist's inclusion to improve treatment&#xD;
      outcomes in rheumatoid arthritis.There are no reported figures for adherence to treatment and&#xD;
      medications for RA or any musculoskeletal disease. Studies conducted in Pakistan also&#xD;
      highlight that pharmacists have the potential to improve economic, clinical and humanistic&#xD;
      outcomes by providing pharmaceutical care to patients. However, it is to be seen if&#xD;
      pharmacist can actually achieve the milestone i.e. improve patient treatment outcomes of&#xD;
      rheumatoid arthritis. A randomized trial is therefore needed employing pharmacist&#xD;
      intervention in RA patients. This present an excellent opportunity to identify the areas&#xD;
      where a pharmacist has the potential to play his/her role and evaluate its effectiveness.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 19, 2017</start_date>
  <completion_date type="Actual">August 17, 2018</completion_date>
  <primary_completion_date type="Actual">August 1, 2018</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>Double (Investigator, Outcomes Assessor)</masking>
    <masking_description>Investigator will be blinded. Outcome assessor would be blinded. Patients in the control group would be blinded.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Disease knowledge</measure>
    <time_frame>Week 12 from baseline</time_frame>
    <description>Knowledge about rheumatoid arthritis</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Medication Adherence</measure>
    <time_frame>Week 12 from baseline</time_frame>
    <description>Patients' adherence to their medications</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Health Related Quality of Life (HR-QOL)</measure>
    <time_frame>Week 12 from baseline</time_frame>
    <description>Rheumatoid arthritis patients' health related quality of life</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Treatment Adherence</measure>
    <time_frame>Week 12 from baseline</time_frame>
    <description>Patients' adherence to their rehabilitation</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Direct Cost of treatment</measure>
    <time_frame>Week 12 from baseline</time_frame>
    <description>Direct cost of rheumatoid arthritis treatment on patient's pocket</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Disease Activity</measure>
    <time_frame>Week 12 from baseline</time_frame>
    <description>The disease activity was assessed by disease activity score (DAS) also known as DAS - 28 score.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Adverse events</measure>
    <time_frame>Week 12 from baseline</time_frame>
    <description>The adverse events were assessed directly through patients' medical history that was available in hospital database.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Patient satisfaction</measure>
    <time_frame>At Week 12</time_frame>
    <description>Patient satisfaction from pharmacists in managing rheumatoid arthritis</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">400</enrollment>
  <condition>Rheumatoid Arthritis</condition>
  <arm_group>
    <arm_group_label>Pharmacist intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Disease education (General education about rheumatoid arthritis in a verbal and written manner)&#xD;
Dietary and lifestyle modifications (General recommendations as well as specific ones based on patients' baseline health status)&#xD;
Counseling regarding adherence (General lecture on adherence to medications and physical rehabilitation in rheumatoid arthritis as well as specific advice based on patients health status)&#xD;
Advice on medication use (General counseling on medication use as well as patient centered counseling).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Usual care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Patients will not be counseled by pharmacist and will be allowed to take usual care.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Pharmacist led pharmaceutical care</intervention_name>
    <description>The intervention in the study will be a pharmacist's intervention that will be provided to rheumatoid arthritis patients in order to improve their treatment outcomes. It will be in the form of a single (1) session by pharmacist (face-to-face) followed by written material for use at home. The pharmacist will look at the patient's baseline data and provide counseling. The venue for counseling will be the hospitals.</description>
    <arm_group_label>Pharmacist intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Out-patients with established diagnosis of rheumatoid arthritis over 3 months.&#xD;
&#xD;
          -  Participants who are willing to participate in the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with no rheumatoid arthritis.&#xD;
&#xD;
          -  Patients currently undergoing surgery or had previous history of surgery.&#xD;
&#xD;
          -  Patients with more than 3 comorbidities.&#xD;
&#xD;
          -  Patients who are not willing to participate.&#xD;
&#xD;
          -  In-patients will not be included.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Azmi A Hassali, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Universiti Sains Malaysia</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Clifton Central Hospital</name>
      <address>
        <city>Karachi</city>
        <state>Sindh</state>
        <zip>75600</zip>
        <country>Pakistan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Pakistan</country>
  </location_countries>
  <verification_date>March 2020</verification_date>
  <study_first_submitted>August 15, 2017</study_first_submitted>
  <study_first_submitted_qc>August 15, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 18, 2017</study_first_posted>
  <last_update_submitted>March 26, 2020</last_update_submitted>
  <last_update_submitted_qc>March 26, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">March 30, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Universiti Sains Malaysia</investigator_affiliation>
    <investigator_full_name>Atta Abbas Naqvi</investigator_full_name>
    <investigator_title>Atta Abbas Naqvi</investigator_title>
  </responsible_party>
  <keyword>Rheumatoid Arthritis</keyword>
  <keyword>Pakistan</keyword>
  <keyword>Pharmacist</keyword>
  <keyword>Intervention</keyword>
  <keyword>Treatment outcome</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Arthritis</mesh_term>
    <mesh_term>Arthritis, Rheumatoid</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT03254745
org study id: PACT1
nct id: NCT03254745
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Rheumatoid arthritis is an auto-immune disorders that mainly affects the joints. It may also
      affect other organs of the body such as skin, eyes, lungs and heart. The immune system of the
      body attacks the lining of the joint that results in erosion and joint deformity. This
      condition if untreated may lead to disability. RA is managed by medications known as disease
      modifying anti rheumatic drugs (DMARDs) as well as physical therapy. Dietary and lifestyle
      modification may also ease the condition.
One of the major problems in managing RA is adherence to rehabilitation and medication.
      Studies report low adherence to medication among patients of RA. Certain barriers to
      rehabilitation also exists which may include exhaustive treatment attendance, time management
      and direct costs. Patient intentionally make decisions of non adherence to their prescribed
      rehabilitation schedule and medication regimen. This may be due to suffering from adverse
      drug reactions (ADRs) of medications, excessive pain arising from physical therapy and/or
      out-of-pocket costs.

      Pharmacists have the potential to improve the patient's clinical, humanistic and economic
      outcomes in rheumatoid arthritis by providing pharmaceutical care. This can be executed by:

        1. Resolving drug related problems and managing drug therapy

        2. Management of modifiable risk factors such as weight

        3. Recommending dietary and lifestyle changes

        4. Providing patient counseling, disease education and medication advice

        5. Reducing the out-of-pocket costs

        6. Improve overall well being and quality of life

      Evidence from the past indicates a varying prevalence of RA in Pakistan. Figures for
      prevalence of RA varied geographically as literature reported a prevalence of 0.142% to 5.5%
      in the southern and northern region of Pakistan respectively. Recently, a study conducted in
      a tertiary care unit in the city of Karachi located in southern region reported a figure of
      633 (12.9%) for RA patients out of total 4900 patients who visited rheumatology clinic in the
      hospital. It highlighted that disease burden in this region has dramatically increased.

      Most Pakistani patients lack adequate disease knowledge and awareness regarding RA. Moreover,
      patients in Pakistan have to pay direct medical cost in most of the cases. In the past,
      studies have highlighted that Pakistani patients view costs per session and treatment
      attendance as major barriers to undergo physical therapy sessions for rheumatological
      disorders.

      There is a dearth of literature reported on pharmacist's inclusion to improve treatment
      outcomes in rheumatoid arthritis.There are no reported figures for adherence to treatment and
      medications for RA or any musculoskeletal disease. Studies conducted in Pakistan also
      highlight that pharmacists have the potential to improve economic, clinical and humanistic
      outcomes by providing pharmaceutical care to patients. However, it is to be seen if
      pharmacist can actually achieve the milestone i.e. improve patient treatment outcomes of
      rheumatoid arthritis. A randomized trial is therefore needed employing pharmacist
      intervention in RA patients. This present an excellent opportunity to identify the areas
      where a pharmacist has the potential to play his/her role and evaluate its effectiveness.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: Double (Investigator, Outcomes Assessor)
masking description: Investigator will be blinded. Outcome assessor would be blinded. Patients in the control group would be blinded.
measure: Disease knowledge
time frame: Week 12 from baseline
description: Knowledge about rheumatoid arthritis
measure: Medication Adherence
time frame: Week 12 from baseline
description: Patients' adherence to their medications
measure: Health Related Quality of Life (HR-QOL)
time frame: Week 12 from baseline
description: Rheumatoid arthritis patients' health related quality of life
measure: Treatment Adherence
time frame: Week 12 from baseline
description: Patients' adherence to their rehabilitation
measure: Direct Cost of treatment
time frame: Week 12 from baseline
description: Direct cost of rheumatoid arthritis treatment on patient's pocket
measure: Disease Activity
time frame: Week 12 from baseline
description: The disease activity was assessed by disease activity score (DAS) also known as DAS - 28 score.
measure: Adverse events
time frame: Week 12 from baseline
description: The adverse events were assessed directly through patients' medical history that was available in hospital database.
measure: Patient satisfaction
time frame: At Week 12
description: Patient satisfaction from pharmacists in managing rheumatoid arthritis
arm group label: Pharmacist intervention
arm group type: Experimental
description: Disease education (General education about rheumatoid arthritis in a verbal and written manner)
Dietary and lifestyle modifications (General recommendations as well as specific ones based on patients' baseline health status)
Counseling regarding adherence (General lecture on adherence to medications and physical rehabilitation in rheumatoid arthritis as well as specific advice based on patients health status)
Advice on medication use (General counseling on medication use as well as patient centered counseling).
arm group label: Usual care
arm group type: No Intervention
description: Patients will not be counseled by pharmacist and will be allowed to take usual care.
intervention type: Other
intervention name: Pharmacist led pharmaceutical care
description: The intervention in the study will be a pharmacist's intervention that will be provided to rheumatoid arthritis patients in order to improve their treatment outcomes. It will be in the form of a single (1) session by pharmacist (face-to-face) followed by written material for use at home. The pharmacist will look at the patient's baseline data and provide counseling. The venue for counseling will be the hospitals.
arm group label: Pharmacist intervention
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Azmi A Hassali, PhD
role: Study Director
affiliation: Universiti Sains Malaysia
facility: 
country: Pakistan
responsible party type: Principal Investigator
investigator affiliation: Universiti Sains Malaysia
investigator full name: Atta Abbas Naqvi
investigator title: Atta Abbas Naqvi
mesh term: Arthritis
mesh term: Arthritis, Rheumatoid
sharing ipd: No