<?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>IRCT2016050212452N3</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2017-01-07</date_registration>
      <primary_sponsor>Vice chancellor for research,Shahrekord University of Medical Sciences</primary_sponsor>
      <public_title>Effectiveness of care plan on problems caregivers of patients with epilepsy.</public_title>
      <acronym></acronym>
      <scientific_title>The effect of family-centered care on the family caregivers' burden, stress, anxiety and depression of epilepsy patients .</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2016-07-02</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>100</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/12527</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Prevention, Other design features: Randomized with a random numbers table.</study_design>
      <phase>N/A</phase>
      <hc_freetext>epilepsy.</hc_freetext>
      <i_freetext>Intervention 1: Group test: the implementation of family-centered care program (first step: the perceived threat Step two: self-efficacy Upgrade Step Three: Self-Esteem Step Four: Evaluation) of caregivers of patients with epilepsy for four meeting two-hour , issues related to epilepsy, causes epilepsy, treatment,  emergency of epilepsy,role of caregiver, sources of support, educational package includes a manual and CD, is provided  by a steady group of neurologist  doctors and nurses and psychiatric nursing. Before and after and two months after the intervention was completed questionnairesr. Intervention 2: Control group: no intervention on control group . questionnaires (before, after and two months after the intervention on intervention groups) are completed.</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></results_IPD_plan>
      <results_IPD_description></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>maryam heidari soureshjani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>shahrekord Street Kashani</address>
        <city>shahrekord</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 383335654</telephone>
        <email>heidari93_m@yahoo.com</email>
        <affiliation>shahrekord University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>shahram eatamadifar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>University of Medical Sciences</address>
        <city>University of Medical Sciences  Shahr e Kord</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 383335654</telephone>
        <email>sh_etemadifar@yahoo.com</email>
        <affiliation>University of Medical Sciences shahrekord</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: According to patient,  their family or carer as caregivers and bear a lot of responsibility of patiens . Age over 18 (and caregivers of patients) years. &#13;
Be able to communicate and participate in all training sessions.&#13;
Is not involveded  in the family training sessions (any other research project) earlier.&#13;
 According to medical records are not known history of severe physical illness and mental disorder. No other patient care at the same time. Lack of crisis or major stress during the past year.  patients have  Grand Mal epilepsy type.Caregiver care of patient at least 3 hours daily.&#13;
Exclusion criteria:Carers are not willing to continue to participate in the study. Other disease during the study, which followed patients require extra care needs. Those are who care for patients who have other diseases in addition to epilepsy, neuromuscular spinal cord injuries, head injuries decreased level of consciousness, mental retardation and visual cognitive disorders, alcoholism and drug abuse, former multiple strokes, mentally ill. Stressful events occurring during the intervention for caregivers. Serious physical disease</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>g41.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Grand mal status epilepticus      Tonic-clonic status epilepticus  Excl.:     epilepsia partialis continua [Kozhevnikof] (G40.5)</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Other</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Group test: the implementation of family-centered care program (first step: the perceived threat Step two: self-efficacy Upgrade Step Three: Self-Esteem Step Four: Evaluation) of caregivers of patients with epilepsy for four meeting two-hour , issues related to epilepsy, causes epilepsy, treatment,  emergency of epilepsy,role of caregiver, sources of support, educational package includes a manual and CD, is provided  by a steady group of neurologist  doctors and nurses and psychiatric nursing. Before and after and two months after the intervention was completed questionnairesr</i_keyword>
      <i_keyword>Control group: no intervention on control group . questionnaires (before, after and two months after the intervention on intervention groups) are completed.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Burden of care. Timepoint: Before, immediately after and two months after intervention. Method of measurement: Persian and standardized questionnaire Zaryt.</prim_outcome>
      <prim_outcome>Stress. Timepoint: Before, immediately after and two months after intervention. Method of measurement: A standard questionnaire was summarized and Persian DOS (Form 21 questions.</prim_outcome>
      <prim_outcome>Anxiety. Timepoint: Before, immediately after and two months after intervention. Method of measurement: A standard questionnaire was summarized and Persian DOS (Form 21 questions.</prim_outcome>
      <prim_outcome>Depration. Timepoint: Before, immediately after and two months after intervention. Method of measurement: A standard questionnaire was summarized and Persian DOS (Form 21 questions.</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>Vice chancellor for research,Shahrekord University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2016-11-24</approval_date>
        <contact_name>Ethics committee of shahrekord University of Medical Sciences</contact_name>
        <contact_address>Shahr e Kord. Kashani Ave. shahrekord  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
