<?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>IRCT2017061934632N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2017-08-16</date_registration>
      <primary_sponsor>Vice chancellor for research, Tarbiat Modares University</primary_sponsor>
      <public_title>Family-centered empowerment model for enhance quality of life of female patients with Pemphigus Vulgaris and active family member.</public_title>
      <acronym>-</acronym>
      <scientific_title>comparison of the effect of family-centered empowerment model based lifestyle modification on quality of life of female patients with Pemphigus Vulgaris and active family member in the intervention group with no implementation of the model in patients and active family member in the control group.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-06-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>144</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/26425</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Health service research, Randomization description: In this study, the research samples were selected by the researcher using the purposeful sampling method by studying the patients' files to reach the qualified patients more precisely, according to the entry criteria and after assimilation by one of the nurses based on the criteria of age, type of disease, severity of the disease and duration of the disease, the block was randomly assigned and then, using the Minimization method, the samples were homogenized by SPSS software and by using lottery and randomly, the research samples were placed in one of the control or intervention groups.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Pemphigus Vulgaris.</hc_freetext>
      <i_freetext>Intervention 1: After analyzing the data before the intervention, which led to the identification of the resources, limitations, needs and strengths of the patient and his active family member in different fields, Changes were made in the previously designed empowerment program for these patients, so that the implementation of the empowerment model fits the needs and demands of the research samples. After the pre-test, the intervention phase began and since this study was conducted as an intervention and control; The intervention phase was performed only for the intervention group and the control group did not receive any intervention. In the intervention group, the family-centered empowerment model in executive steps (understanding the threat, internalizing the axis of control, self-efficacy, self-belief, self-control, follow-up and evaluation) for 8 sessions by group problem solving method and using educational participation method and adult educational theory for The intervention group was implemented and after 6 weeks, were compared with the control group. Intervention 2: Conducting the pre-test by completing the demographic information questionnaire, the Iranian version of the quality of life index questionnaire for skin patients (DLOQI), the quality of life questionnaire (SF-36), the family specific questionnaire of skin patients (FDLOQI), the Iranian version of the Walker and Pender lifestyle questionnaire, Questionnaire for measuring the patient's ability and questionnaire for measuring the ability of the active family member by the patient and the active family member and conducting  post-test 6 weeks after the completion of the intervention in the intervention group by re-completing the main tools for measuring lifestyle and quality of life by the patient and active family member.</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>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is There is no more information.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Fatemah Alhani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>1411713116, No.7, Tarbiat Modares University, Jalal All Ahmad Street, Tehran, IR. Iran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1411713116</zip>
        <telephone>+98 21 8288 3898</telephone>
        <email>alhani_f@modares.ac.ir</email>
        <affiliation>Tarbiat  Modares University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Fatemah Alhani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>1411713116, No.7, Tarbiat Modares University, Jalal All Ahmad Street, Tehran, IR. Iran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1411713116</zip>
        <telephone>+98 21 8288 3898</telephone>
        <email>alhani_f@modares.ac.ir</email>
        <affiliation>Tarbiat  Modares University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>register Pemphigus Vulgaris according to the doctor's diagnosis in the health case
women aged 30-60 years
Patients' and active family member's desire and satisfaction to participate in the research;
Ability to communicate verbally ; provide information and collaborate with the researcher
No mental illness or other acute or chronic illness
Not a member of the health team
having at least literacy to complete the Questionnaire</inclusion_criteria>
      <agemin>30 years</agemin>
      <agemax>60 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>the patient and active family member's unwillingness to continue to participate in research
the patient has an acute or chronic illness
the patient has a mental illness
Patient or active family member death</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>L10.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Pemphigus vulgaris</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Lifestyle</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>After analyzing the data before the intervention, which led to the identification of the resources, limitations, needs and strengths of the patient and his active family member in different fields, Changes were made in the previously designed empowerment program for these patients, so that the implementation of the empowerment model fits the needs and demands of the research samples. After the pre-test, the intervention phase began and since this study was conducted as an intervention and control; The intervention phase was performed only for the intervention group and the control group did not receive any intervention. In the intervention group, the family-centered empowerment model in executive steps (understanding the threat, internalizing the axis of control, self-efficacy, self-belief, self-control, follow-up and evaluation) for 8 sessions by group problem solving method and using educational participation method and adult educational theory for The intervention group was implemented and after 6 weeks, were compared with the control group.</i_keyword>
      <i_keyword>Conducting the pre-test by completing the demographic information questionnaire, the Iranian version of the quality of life index questionnaire for skin patients (DLOQI), the quality of life questionnaire (SF-36), the family specific questionnaire of skin patients (FDLOQI), the Iranian version of the Walker and Pender lifestyle questionnaire, Questionnaire for measuring the patient's ability and questionnaire for measuring the ability of the active family member by the patient and the active family member and conducting  post-test 6 weeks after the completion of the intervention in the intervention group by re-completing the main tools for measuring lifestyle and quality of life by the patient and active family member.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Lifestyle. Timepoint: Before intervention- two months after the end of the intervention. Method of measurement: Walker- Pender health-promoting Lifestyle Questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Quality of public life of female patients with Pemphigus Vulgaris and active family member. Timepoint: Before intervention; two months after the end of the intervention. Method of measurement: SF-36 quality of life Questionnaire.</sec_outcome>
      <sec_outcome>Quality of  Exclusive life of female patients with Pemphigus Vulgaris. Timepoint: Before intervention; two months after the end of the intervention. Method of measurement: Iranian version dermatology life quality index (DLQI).</sec_outcome>
      <sec_outcome>Quality of exclusive life of active family member. Timepoint: Before intervention; two months after the end of the intervention. Method of measurement: The family dermatology life quality index (FDLQI).</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, Tarbiat Modares University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2016-11-09</approval_date>
        <contact_name>Ethics committee of Tarbiat Modares University</contact_name>
        <contact_address>1411713116, No.7, Tarbiat Modares University, Jalal All Ahmad Street, Tehran, IR. Iran Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
