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/NCT06034353</url>
    </required_header>
    <id_info>
      <org_study_id>NA0823</org_study_id>
      <nct_id>NCT06034353</nct_id>
    </id_info>
    <brief_title>Impact of Cognitive Behavioral Intervention on Adherence and Quality of Life of Epileptic Patients</brief_title>
    <official_title>Impact of Cognitive Behavioral Intervention on Adherence and Quality of Life of Epileptic Patients</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Hamdard University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Hamdard University</source>
    <oversight_info>
      <has_dmc>No</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>
        The purpose of this interventional study is to assess the impact of pharmacist-led cognitive&#xD;
        behavioral intervention in epileptic patients. The main questions are:&#xD;
  &#xD;
          1. If pharmacist-led cognitive behavioral therapy can help in improving patient medication&#xD;
             adherence?&#xD;
  &#xD;
          2. How will the cognitive behavioral therapy impact the quality of life of the patients?&#xD;
  &#xD;
        Participants of this study will be provided basic or advanced level counselling and&#xD;
        educational material as part of their routine pharmacy visit.&#xD;
  &#xD;
        Researchers will compare the two groups (Basic and advanced) to see which of the two groups&#xD;
        are better in term of medication adherence and quality of life.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The purpose of the study is to investigate whether incorporation of pharmacist-led cognitive&#xD;
        behavioral therapy (CBT) to the treatment of epileptic patients can result in better&#xD;
        adherence to anti epileptic drugs. In order to manage epilepsy effectively, medication&#xD;
        adherence is essential. Missed doses or irregular drug use can increase the frequency of&#xD;
        seizures and reduce the effectiveness of treatment. In order to improve medicine adherence&#xD;
        rates, the study will examine if cognitive behavioral therapy (CBT) therapies can have a&#xD;
        favorable effect on patients' motivation, coping techniques, Medication beliefs, reduction in&#xD;
        adverse drug reaction (ADRs), Seizures frequency and medication related problems (MRPs) other&#xD;
        than adverse drug reaction (ADRs) and overall quality of life of epileptic patients.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 10, 2023</start_date>
    <completion_date type="Anticipated">March 15, 2024</completion_date>
    <primary_completion_date type="Anticipated">January 15, 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>Supportive Care</primary_purpose>
      <masking>Single (Participant)</masking>
      <masking_description>Participants will be entertained as part of their regular appointment for prescription filling without any information of which group they are assigned in.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Medication adherence</measure>
      <time_frame>3 months</time_frame>
      <description>Adherence will be assessed using (Medication Adherence Reporting Scale) MARS-10.&#xD;
  This scale describes three-dimension, Medication adherence behavior (1-4), attitude towards taking medication (5-8), negative side effects and attitudes to psychotropic medication (9-10). Each question has Yes and No response, a response consistent with adherence is coded as 1 and with non-adherence coded as 0. Higher the score higher will be the adherence. Adherence &lt;6 is poor adherence, and &gt;8 is high adherence.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Quality of life of Epileptic patients</measure>
      <time_frame>3 months</time_frame>
      <description>Patient's quality of life will be assessed using Quality of life for epilepsy scale(QOLIE-31). QOLIE-31(Quality of life in epilepsy) used for quality-of-life assessment which assess the patient's life's quality level along using anti-epileptic drug (AED) therapy through close ended questions with a score. The score can range from 0-100, with 100 representing the best quality of life.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Incidence of Drug-Drug Interactions</measure>
      <time_frame>3 months</time_frame>
      <description>Drug interactions among epileptic and non-epileptic drug will be assessed using standard website (update-Lexicomp) It is used to access the reduction in no. of drug drug interaction after pharmacist intervation in both basic and advance groups.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Incidence of Adverse reactions</measure>
      <time_frame>3 months</time_frame>
      <description>Adverse reactions of all anti-epileptic drug will be noted while assessing a patient.&#xD;
  It is used to access the reduction in frequency of Adverse drug reaction after pharmacist intervation in both basic and advance groups.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Rate of seizures per week</measure>
      <time_frame>3 months</time_frame>
      <description>While assessing patient no. of seizures per week is asked and noted by the pharmacist. After intervening both basic and advance group impact of intervation is accessed for no. of seizures in the groups.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">400</enrollment>
    <condition>Epilepsy</condition>
    <arm_group>
      <arm_group_label>Basic group</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Lifestyle Modifications: General education about healthy life style and diet. Education : general awareness about disease and medication Pill Planner: Pill planner will be provided to keep them adherent to their medication Counselling: Counsel the patients about there medication dosage, frequency and appropriate time.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Advanced</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Lifestyle Modifications: Specific education on keto-diet, yoga and meditation Education : Specific disease education targeting medication adverse drug reaction (ADR), seizure chart management Pill Planner: Pill planner will also be provided to this group Counselling: Cognitive Behavioral therapy will be provided</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Pharmacist-led Cognitive Behavioral therapy</intervention_name>
      <description>Pharmacist-led Cognitive Behavioral therapy is patient centered approach that focus both physical and emotional aspect of health is provided. It is focused to identify negative and change negative thought pattern and behavior to improve mental and physical well being.Incorporation education about healthy meal choices, relaxation techniques, self management strategies,to improve education about potential adverse effect, how to recognize and on followup calls how to adjust medication doses along with this is provided.</description>
      <arm_group_label>Advanced</arm_group_label>
      <arm_group_label>Basic group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patients with confirmed diagnosis.&#xD;
  &#xD;
            -  Patients treated for epilepsy with at least one anti epileptic drug, subjects willing&#xD;
               to participate in the study with or without other severe co-morbidities were included&#xD;
               in the study.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Pregnant female patients.&#xD;
  &#xD;
            -  Patients who provide incomplete information&#xD;
  &#xD;
            -  Patients with any terminal disease e.g., end stage renal disease&#xD;
  &#xD;
            -  Patients not willing to participate were excluded from the study.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>15 Years</minimum_age>
      <maximum_age>70 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Matti Ullah, PhD</last_name>
      <role>Study Director</role>
      <affiliation>Hamdard University Islamabad Campus</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Iqra Farooq, MPhil</last_name>
      <role>Principal Investigator</role>
      <affiliation>Shifa International Hospital</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Muhammad Shafiq, BS. (Hons.)</last_name>
      <role>Study Chair</role>
      <affiliation>Subhan Medical Trust</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Emmama Jamil, MPhil</last_name>
      <role>Study Chair</role>
      <affiliation>Hamdard University Islamabad Campus</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Matti Ullah, PhD</last_name>
      <phone>09203315056501</phone>
      <email>mattiullah@hotmail.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Iqra Farooq, MPhil</last_name>
      <email>iqra0989@gmail.com</email>
    </overall_contact_backup>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 2, 2023</study_first_submitted>
    <study_first_submitted_qc>September 10, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 13, 2023</study_first_posted>
    <last_update_submitted>September 12, 2023</last_update_submitted>
    <last_update_submitted_qc>September 12, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Hamdard University</investigator_affiliation>
      <investigator_full_name>Matti Ullah</investigator_full_name>
      <investigator_title>Assistant Professor</investigator_title>
    </responsible_party>
    <keyword>Cognitive behavioral therapy</keyword>
    <keyword>Pharmacist</keyword>
    <keyword>Medication Adherence</keyword>
    <keyword>Quality of life</keyword>
    <patient_data>
      <sharing_ipd>Undecided</sharing_ipd>
      <ipd_description>Sharing patient data will depend on the patient's consent. If the patient doesn't allow to share data with others, we will not be able to share individual data.</ipd_description>
    </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/NCT06034353
  org study id: NA0823
  nct id: NCT06034353
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The purpose of this interventional study is to assess the impact of pharmacist-led cognitive
        behavioral intervention in epileptic patients. The main questions are:
  
          1. If pharmacist-led cognitive behavioral therapy can help in improving patient medication
             adherence?
  
          2. How will the cognitive behavioral therapy impact the quality of life of the patients?
  
        Participants of this study will be provided basic or advanced level counselling and
        educational material as part of their routine pharmacy visit.
  
        Researchers will compare the two groups (Basic and advanced) to see which of the two groups
        are better in term of medication adherence and quality of life.
  The purpose of the study is to investigate whether incorporation of pharmacist-led cognitive
        behavioral therapy (CBT) to the treatment of epileptic patients can result in better
        adherence to anti epileptic drugs. In order to manage epilepsy effectively, medication
        adherence is essential. Missed doses or irregular drug use can increase the frequency of
        seizures and reduce the effectiveness of treatment. In order to improve medicine adherence
        rates, the study will examine if cognitive behavioral therapy (CBT) therapies can have a
        favorable effect on patients' motivation, coping techniques, Medication beliefs, reduction in
        adverse drug reaction (ADRs), Seizures frequency and medication related problems (MRPs) other
        than adverse drug reaction (ADRs) and overall quality of life of epileptic patients.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Supportive Care
  masking: Single (Participant)
  masking description: Participants will be entertained as part of their regular appointment for prescription filling without any information of which group they are assigned in.
  measure: Medication adherence
  time frame: 3 months
  description: Adherence will be assessed using (Medication Adherence Reporting Scale) MARS-10.
  This scale describes three-dimension, Medication adherence behavior (1-4), attitude towards taking medication (5-8), negative side effects and attitudes to psychotropic medication (9-10). Each question has Yes and No response, a response consistent with adherence is coded as 1 and with non-adherence coded as 0. Higher the score higher will be the adherence. Adherence <6 is poor adherence, and >8 is high adherence.
  measure: Quality of life of Epileptic patients
  time frame: 3 months
  description: Patient's quality of life will be assessed using Quality of life for epilepsy scale(QOLIE-31). QOLIE-31(Quality of life in epilepsy) used for quality-of-life assessment which assess the patient's life's quality level along using anti-epileptic drug (AED) therapy through close ended questions with a score. The score can range from 0-100, with 100 representing the best quality of life.
  measure: Incidence of Drug-Drug Interactions
  time frame: 3 months
  description: Drug interactions among epileptic and non-epileptic drug will be assessed using standard website (update-Lexicomp) It is used to access the reduction in no. of drug drug interaction after pharmacist intervation in both basic and advance groups.
  measure: Incidence of Adverse reactions
  time frame: 3 months
  description: Adverse reactions of all anti-epileptic drug will be noted while assessing a patient.
  It is used to access the reduction in frequency of Adverse drug reaction after pharmacist intervation in both basic and advance groups.
  measure: Rate of seizures per week
  time frame: 3 months
  description: While assessing patient no. of seizures per week is asked and noted by the pharmacist. After intervening both basic and advance group impact of intervation is accessed for no. of seizures in the groups.
  arm group label: Basic group
  arm group type: Active Comparator
  description: Lifestyle Modifications: General education about healthy life style and diet. Education : general awareness about disease and medication Pill Planner: Pill planner will be provided to keep them adherent to their medication Counselling: Counsel the patients about there medication dosage, frequency and appropriate time.
  arm group label: Advanced
  arm group type: Experimental
  description: Lifestyle Modifications: Specific education on keto-diet, yoga and meditation Education : Specific disease education targeting medication adverse drug reaction (ADR), seizure chart management Pill Planner: Pill planner will also be provided to this group Counselling: Cognitive Behavioral therapy will be provided
  intervention type: Behavioral
  intervention name: Pharmacist-led Cognitive Behavioral therapy
  description: Pharmacist-led Cognitive Behavioral therapy is patient centered approach that focus both physical and emotional aspect of health is provided. It is focused to identify negative and change negative thought pattern and behavior to improve mental and physical well being.Incorporation education about healthy meal choices, relaxation techniques, self management strategies,to improve education about potential adverse effect, how to recognize and on followup calls how to adjust medication doses along with this is provided.
  arm group label: Advanced
  arm group label: Basic group
  criteria: 
  gender: All
  minimum age: 15 Years
  maximum age: 70 Years
  healthy volunteers: No
  last name: Matti Ullah, PhD
  role: Study Director
  affiliation: Hamdard University Islamabad Campus
  last name: Iqra Farooq, MPhil
  role: Principal Investigator
  affiliation: Shifa International Hospital
  last name: Muhammad Shafiq, BS. (Hons.)
  role: Study Chair
  affiliation: Subhan Medical Trust
  last name: Emmama Jamil, MPhil
  role: Study Chair
  affiliation: Hamdard University Islamabad Campus
  last name: Matti Ullah, PhD
  phone: 09203315056501
  email: mattiullah@hotmail.com
  last name: Iqra Farooq, MPhil
  email: iqra0989@gmail.com
  responsible party type: Principal Investigator
  investigator affiliation: Hamdard University
  investigator full name: Matti Ullah
  investigator title: Assistant Professor
  sharing ipd: Undecided
  ipd description: Sharing patient data will depend on the patient's consent. If the patient doesn't allow to share data with others, we will not be able to share individual data.