<?xml version="1.0" encoding="utf-8"?>
<!DOCTYPE trials [
<!ELEMENT trials (trial+)>

<!ELEMENT trial (main,contacts,countries,criteria,health_condition_code,health_condition_keyword,intervention_code,
          intervention_keyword,primary_outcome,secondary_outcome,secondary_sponsor,secondary_ids,source_support,ethics_reviews)>

<!ELEMENT main (trial_id,utrn?,reg_name,date_registration,primary_sponsor,public_title,acronym?,scientific_title,scientific_acronym?,
          date_enrolment,type_enrolment,target_size,recruitment_status,url?,study_type,study_design,phase,hc_freetext?,i_freetext?,results_actual_enrolment,results_date_completed,results_url_link,results_summary,           results_date_posted,results_date_first_publication,results_baseline_char,results_participant_flow,results_adverse_events,results_outcome_measures,results_url_protocol,results_IPD_plan, results_IPD_description)>
<!ELEMENT trial_id (#PCDATA)>
<!ELEMENT utrn (#PCDATA)>
<!ELEMENT reg_name (#PCDATA)>
<!ELEMENT date_registration (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT primary_sponsor (#PCDATA)>
<!ELEMENT public_title (#PCDATA)>
<!ELEMENT acronym (#PCDATA)>
<!ELEMENT scientific_title (#PCDATA)>
<!ELEMENT scientific_acronym (#PCDATA)>
<!ELEMENT date_enrolment (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT type_enrolment (#PCDATA)>
<!ELEMENT target_size (#PCDATA)>
<!ELEMENT recruitment_status (#PCDATA)><!-- Pending,Recruiting,Suspended,Complete,Other -->
<!ELEMENT url (#PCDATA)>
<!ELEMENT study_type (#PCDATA)><!-- interventional,observational -->
<!ELEMENT study_design (#PCDATA)>
<!ELEMENT phase (#PCDATA)>
<!ELEMENT hc_freetext (#PCDATA)>
<!ELEMENT i_freetext (#PCDATA)>
<!ELEMENT results_actual_enrolment (#PCDATA)>
<!ELEMENT results_date_completed (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_url_link (#PCDATA)>
<!ELEMENT results_summary (#PCDATA)>
<!ELEMENT results_date_posted (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_date_first_publication (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_baseline_char (#PCDATA)>
<!ELEMENT results_participant_flow (#PCDATA)>
<!ELEMENT results_adverse_events (#PCDATA)>
<!ELEMENT results_outcome_measures (#PCDATA)>
<!ELEMENT results_url_protocol (#PCDATA)>
<!ELEMENT results_IPD_plan (#PCDATA)>
<!ELEMENT results_IPD_description (#PCDATA)>


<!ELEMENT contacts (contact+)>
<!ELEMENT contact (type,firstname,middlename,lastname,address,city,country1,zip,telephone,email,affiliation)>
<!ELEMENT type (#PCDATA)><!-- Public,Scientific -->
<!ELEMENT firstname (#PCDATA)>
<!ELEMENT middlename (#PCDATA)>
<!ELEMENT lastname (#PCDATA)>
<!ELEMENT address (#PCDATA)>
<!ELEMENT city (#PCDATA)>
<!ELEMENT country1 (#PCDATA)>
<!ELEMENT zip (#PCDATA)>
<!ELEMENT telephone (#PCDATA)>
<!ELEMENT email (#PCDATA)>
<!ELEMENT affiliation (#PCDATA)>

<!ELEMENT countries (country2+)>
<!ELEMENT country2 (#PCDATA)>

<!ELEMENT criteria (inclusion_criteria,agemin,agemax,gender,exclusion_criteria)>
<!ELEMENT inclusion_criteria (#PCDATA)>
<!ELEMENT agemin (#PCDATA)>
<!ELEMENT agemax (#PCDATA)>
<!ELEMENT gender (#PCDATA)>
<!ELEMENT exclusion_criteria (#PCDATA)>

<!ELEMENT health_condition_code (hc_code+)>
<!ELEMENT hc_code (#PCDATA)>

<!ELEMENT health_condition_keyword (hc_keyword+)>
<!ELEMENT hc_keyword (#PCDATA)>

<!ELEMENT intervention_code (i_code+)>
<!ELEMENT i_code (#PCDATA)>

<!ELEMENT intervention_keyword (i_keyword+)>
<!ELEMENT i_keyword (#PCDATA)>

<!ELEMENT primary_outcome (prim_outcome+)>
<!ELEMENT prim_outcome (#PCDATA)>

<!ELEMENT secondary_outcome (sec_outcome+)>
<!ELEMENT sec_outcome (#PCDATA)>

<!ELEMENT secondary_sponsor (sponsor_name+)>
<!ELEMENT sponsor_name (#PCDATA)>

<!ELEMENT secondary_ids (secondary_id+)>
<!ELEMENT secondary_id (sec_id,issuing_authority)>
<!ELEMENT sec_id (#PCDATA)>
<!ELEMENT issuing_authority (#PCDATA)>

<!ELEMENT source_support (source_name+)>
<!ELEMENT source_name (#PCDATA)>

<!ELEMENT ethics_reviews (ethics_review+)>
<!ELEMENT ethics_review (status,approval_date,contact_name,contact_address,contact_phone,contact_email)>
<!ELEMENT status (#PCDATA)><!-- Not approved,Approved,NA -->
<!ELEMENT approval_date (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT contact_name (#PCDATA)>
<!ELEMENT contact_address (#PCDATA)>
<!ELEMENT contact_phone (#PCDATA)>
<!ELEMENT contact_email (#PCDATA)>
]>
<trials>
  <trial>
    <main>
      <trial_id>IRCT20221220056879N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-10-12</date_registration>
      <primary_sponsor>Shahre-kord University of Medical Sciences</primary_sponsor>
      <public_title>The effect of the implemention of the care program on the continuous care model on activities of daily living and sleep quality of patients with epilepsy</public_title>
      <acronym></acronym>
      <scientific_title>The effect of the implemention of the care program on the continuous care model on activities of daily living and sleep quality of patients with epilepsy</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-05-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>62</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/68298</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Patients with grand mal epilepsy referred to Shahrekord medical centers affiliated to Shahrekord University of Medical Sciences are allocated to intervention and control groups by sampling method based on the purpose of selection and then by card selection method. In this way, 31 cards related to the intervention group and 31 cards related to the control group are placed in the envelope, and then the clients are asked to randomly pick one of them, and in this way, the client is assigned to the group listed on the card.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Epilepsy.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Demographic data questionnaire, Persian version of Barthel's daily life activities questionnaire and Petersburg Sleep Quality Questionnaire (PSQI) whose validity and reliability have been proven in Iran are completed by both groups and the intervention work For the group, the test begins, which takes place in four steps, including familiarization, sensitization, follow-up, and evaluation, and is carried out for eight weeks. The content of the training program takes place in five sessions. Familiarization and sensitization stages are carried out for three weeks and control and evaluation stages for five weeks. Questionnaires are completed by the intervention group before, immediately after and two months after the intervention. Intervention 2: Control group: they only receive routine training in the first phase of familiarization, and this includes how to deal with the patient and his family in an emergency when a seizure attack occurs, and questionnaires in the three phases before, immediately after the intervention and two months after The intervention is completed by the control group.</i_freetext>
      <results_actual_enrolment></results_actual_enrolment>
      <results_date_completed></results_date_completed>
      <results_url_link></results_url_link>
      <results_summary></results_summary>
      <results_date_posted></results_date_posted>
      <results_date_first_publication></results_date_first_publication>
      <results_baseline_char></results_baseline_char>
      <results_participant_flow></results_participant_flow>
      <results_adverse_events></results_adverse_events>
      <results_outcome_measures></results_outcome_measures>
      <results_url_protocol></results_url_protocol>
      <results_IPD_plan>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is The release of raw data has no logical justification except for a data bank suitable for analysis.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Hamidreza Amirhosseini</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No.55 , Salmane farsi Ave., Farhangian 3 Faz., Shahid rafiee pour street</address>
        <city>Ramhormoz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6381675178</zip>
        <telephone>+98 61 4352 8649</telephone>
        <email>www.h.r.amirhosseini@gmail.com</email>
        <affiliation>Shahre-kord University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Hamidreza Amirhosseini</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No.55 , Salmane farsi Ave., Farhangian 3 Faz., Shahid rafiee pour street</address>
        <city>Ramhormoz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6381675178</zip>
        <telephone>+98 61 4352 8649</telephone>
        <email>www.h.r.amirhosseini@gmail.com</email>
        <affiliation>Shahre-kord University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>The diagnosis of grand mal epilepsy in patients based on clinical symptoms, the results of abnormal electroencephalogram (EEG) waves and the doctor's diagnosis.
The age range of patients is over 18 years old.
Having normal hearing, vision and mental strength to enable him to communicate.
To have the ability and literacy to read and write.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>patients who do not want to continue attending the study for any reason.
Creating an acute and serious illness, problem or stress that somehow prevents them from continuing interventions during the intervention period.
Absent more than one session in training sessions.
Incompletely filling out questionnaires.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>G40.3</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Generalized idiopathic epilepsy and epileptic syndromes</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Lifestyle</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Demographic data questionnaire, Persian version of Barthel's daily life activities questionnaire and Petersburg Sleep Quality Questionnaire (PSQI) whose validity and reliability have been proven in Iran are completed by both groups and the intervention work For the group, the test begins, which takes place in four steps, including familiarization, sensitization, follow-up, and evaluation, and is carried out for eight weeks. The content of the training program takes place in five sessions. Familiarization and sensitization stages are carried out for three weeks and control and evaluation stages for five weeks. Questionnaires are completed by the intervention group before, immediately after and two months after the intervention.</i_keyword>
      <i_keyword>Control group: they only receive routine training in the first phase of familiarization, and this includes how to deal with the patient and his family in an emergency when a seizure attack occurs, and questionnaires in the three phases before, immediately after the intervention and two months after The intervention is completed by the control group.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Score of activities of daily living in Barthel questionnaire. Timepoint: The score of activities  of daily living in patients with epilepsy before, immediately and two months after the intervention. Method of measurement: Questionnaire (score 0 to 100).</prim_outcome>
      <prim_outcome>Sleep quality score in the Petersburg questionnaire. Timepoint: Sleep quality score in patients with epilepsy before, immediately and two months after the intervention. Method of measurement: Questionnaire (score 0 to 21).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome></sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name></sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Shahre-kord University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-03-12</approval_date>
        <contact_name>Ethics committee of Shahrekord University of Medical Sciences</contact_name>
        <contact_address>No.55 , Salmane farsi Ave., Farhangian 3 Faz., Shahid rafiee pour street Ramhormoz Khouzestan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
