<?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>IRCT2015100624395N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2015-12-30</date_registration>
      <primary_sponsor>Vice chancellor for research, Mashhad University of Medical Sciences</primary_sponsor>
      <public_title>The effect of education based on the family-centered empowerment model on anticoagulant adherence of patients with prosthetic heart valve.</public_title>
      <acronym></acronym>
      <scientific_title>The effect of education based on the family-centered empowerment model on anticoagulant adherence of patients with prosthetic heart valve.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2015-08-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/20611</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Valvular heart disease.</hc_freetext>
      <i_freetext>Intervention 1: The education will be implemented based on the family-centered empowerment model steps as follows: 1- the first step is to increase the participants’ perceived threat (severity and susceptibility). The perceived severity means to understand the risk of the absence of proper caring behavior and the perceived susceptibility means to comprehend how a person is at risk for the diseases resulting from lack of proper caring behavior. Thus, by  Two 45-60 minute sessions  by Individual Training, group discussions and question and answer that will lead to complications and problems, we will try to improve the perceived threat (severity and perceived susceptibility). 2- the second step is problem solving. Problem solving will be conducted via group discussions in a manner that promotes the participants' self-esteem. The goal of this step is understanding the problems providing their solutions. The problem-solving sessions will hold in  one 45-60minute  small group discussions under supervision of the researcher in discharging day. In these sessions, some objective examples of their problems with the caring behaviors will be presented. Then, the researcher conducts the group-discussion and let them to modify their wrong caring behaviors. At this stage, the caregivers get practically familiar with their problems and their solving process. This issue will enhance their self-efficacy. 3- the third step is participation in the training. In this step, the patient transfer the discussed topics in the previous meetings by the pamphlets and a booklet to active member of the family. 4- the fourth step is evaluation. It includes two stages, process evaluation and final evaluation. The final evaluation will be performed 1.5 months after discharge. Intervention 2: In the control group will be provided to patients and family members one training session 60-45 minutes  in discharge day.</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 Mohammadpour Ostad</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Nursing and Midwifery</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 51 3859 1511</telephone>
        <email>mohammadpoorm2@mums.ac.ir</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Zahra Dalir</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Nursing and Midwifery</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 51 3859 1511</telephone>
        <email>dalirz1@mums.ac.ir</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: Willingness to participate in the study ; The age range of 65- 18 years; living in Mashhad; Artificial valve replacement surgery;The first shift valve replacement surgery; Failure to develop an advanced chronic disease (stroke, kidney failure) and lack cognitive and mental disorders (Alzheimer's, depression); Loss of speech and hearing problems; Having read and write; The patient has no health personnel; A family member (spouse, child, sister, etc.) that further cooperation in the field of health -care and the patient is Family members living with the patient; Lack of family members to valve disease&#13;
&#13;
 Inclusion criteria 10,11 and 12 will be considered for patients in the intervention group.&#13;
&#13;
Inclusion criteria of active member of the family: willingness to participate in research;  having read and write; lack of drug addiction; without the risk of heart valve disease; Is not of Health care worker &#13;
&#13;
Exclusion criteria: unwillingness of research or a member of his family to cooperate at every stage of research; hospitalization for any reason at any stage of research; changes in the anticoagulant medication; The incidence of postoperative complications requiring surgery, physical or mental problems that lead to disability at any stage of the research.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>I39</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Endocarditis and Heart valve Disorders in Diseases Classified Elsewhere</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>The education will be implemented based on the family-centered empowerment model steps as follows: 1- the first step is to increase the participants’ perceived threat (severity and susceptibility). The perceived severity means to understand the risk of the absence of proper caring behavior and the perceived susceptibility means to comprehend how a person is at risk for the diseases resulting from lack of proper caring behavior. Thus, by  Two 45-60 minute sessions  by Individual Training, group discussions and question and answer that will lead to complications and problems, we will try to improve the perceived threat (severity and perceived susceptibility). 2- the second step is problem solving. Problem solving will be conducted via group discussions in a manner that promotes the participants' self-esteem. The goal of this step is understanding the problems providing their solutions. The problem-solving sessions will hold in  one 45-60minute  small group discussions under supervision of the researcher in discharging day. In these sessions, some objective examples of their problems with the caring behaviors will be presented. Then, the researcher conducts the group-discussion and let them to modify their wrong caring behaviors. At this stage, the caregivers get practically familiar with their problems and their solving process. This issue will enhance their self-efficacy. 3- the third step is participation in the training. In this step, the patient transfer the discussed topics in the previous meetings by the pamphlets and a booklet to active member of the family. 4- the fourth step is evaluation. It includes two stages, process evaluation and final evaluation. The final evaluation will be performed 1.5 months after discharge.</i_keyword>
      <i_keyword>In the control group will be provided to patients and family members one training session 60-45 minutes  in discharge day.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Adherence to anticoagulant treatment regimen. Timepoint: one and half month after intervention. Method of measurement: Questionnaire of Adherence to anticoagulant treatment regimen.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Bleeding. Timepoint: Three months after intervention. Method of measurement: Landfield questionnaire.</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, Mashhad University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2015-09-26</approval_date>
        <contact_name>Mashhad University of Medical Sciences</contact_name>
        <contact_address>Deputy of Research and Technology, Mashhad University of Science, next to the Hovyzeh cinema, Daneshgah street, Mashhad Mashhad  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
