<?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>IRCT2015020320940N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2015-08-11</date_registration>
      <primary_sponsor>Vice Chancellor for Research of Zanjan University of Medical Sciences</primary_sponsor>
      <public_title>The Effect of Education to Patient and Family on Self Care and Rehospitalization</public_title>
      <acronym></acronym>
      <scientific_title>Effect of Education Based on Learning Needs to Patient and Family Member on Self-Care Behaviors and Frequency of Rehospitalization in Patients with Heart Failure</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2014-05-31</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>75</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/18481</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Heart  Failure.</hc_freetext>
      <i_freetext>Intervention 1: In group 1, training is done based on the learning needs of patients with a family member, and learning needs of patients are extracted with the CHFPLNI questionnaire.  The training program consisting of diet and medication, fluid and salt restriction, weight control and ………. is performed in three 20-15 minute sessions with 15-minute rest period, during hospitalization and face-to-face in three groups. Intervention 2: In Group 2, training is done based on a preset training booklet without needs assessment and with the presence of a family member.  The training program consisting of diet and medication, fluid and salt restriction, weight control and ………. is performed in three 20-15 minute sessions with 15-minute rest period, during hospitalization and face-to-face in three groups. Intervention 3: in group 3, training is done based on a preset pamphlet without needs assessment and without the presence of a family member.  The training program consisting of diet and medication, fluid and salt restriction, weight control and ………. is performed in three 20-15 minute sessions with 15-minute rest period, during hospitalization and face-to-face in three groups.</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>Saiede Fatemeh Gheiasi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Zanjan School of Nursing and Midwifery School, Parvin Etesami Sq, Zanjan, Iran</address>
        <city>Zanjan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4515789589</zip>
        <telephone>+98 243377251314</telephone>
        <email>fatemeh.gheiasi@gmail.com</email>
        <affiliation>Zanjan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mahin Rohani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Zanjan School of Nursing and Midwifery School, Parvin Etesami Sq, Zanjan, Iran</address>
        <city>Zanjan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4515789589</zip>
        <telephone>+98 98243377251314</telephone>
        <email>mahroo2050@yahoo.com</email>
        <affiliation>Zanjan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients’ inclusion criteria:&#13;
Diagnosis of heart failure confirmed by a cardiologist contained in the file; left ventricular ejection fraction of 35% or less based on the results of echocardiography; at least being once hospitalized due to heart failure in the last year; being admitted to the heart department; being native; accessing to the phone; as well as having a family member over the age of 18 as an attendant; having normal IQ; accessing to daily weighing scales at home&#13;
Family member's inclusion criteria:&#13;
Having a role in patient care; having a causal or relative relationship with the patient &#13;
Patients’ exclusion criteria:&#13;
Terms of acute illness; long traveling during the study; relocation of residence; employment in the medical team; participating in another training program in conjunction with the study; suffering from mental and memory disorders and chronic and debilitating diseases such as renal failure; severe respiratory diseases recorded in their medical records&#13;
Family members’ exclusion criteria:&#13;
Employment in the treatment team; being dissatisfied with continuing participation in the study</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>90 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>IX</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Diseases of The Circulatory System</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>N/A</i_code>
      <i_code>N/A</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>In group 1, training is done based on the learning needs of patients with a family member, and learning needs of patients are extracted with the CHFPLNI questionnaire.  The training program consisting of diet and medication, fluid and salt restriction, weight control and ………. is performed in three 20-15 minute sessions with 15-minute rest period, during hospitalization and face-to-face in three groups</i_keyword>
      <i_keyword>In Group 2, training is done based on a preset training booklet without needs assessment and with the presence of a family member.  The training program consisting of diet and medication, fluid and salt restriction, weight control and ………. is performed in three 20-15 minute sessions with 15-minute rest period, during hospitalization and face-to-face in three groups</i_keyword>
      <i_keyword>in group 3, training is done based on a preset pamphlet without needs assessment and without the presence of a family member.  The training program consisting of diet and medication, fluid and salt restriction, weight control and ………. is performed in three 20-15 minute sessions with 15-minute rest period, during hospitalization and face-to-face in three groups</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Self Care. Timepoint: First and 3 Month after Intervention. Method of measurement: Questionnaire.</prim_outcome>
      <prim_outcome>Rehospitalization. Timepoint: 30, 60 and 90 Days After Intervention. Method of measurement: Questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Family Contribution in Self Care. Timepoint: 3 Months AfterIintervention. Method of measurement: Questionnaire.</sec_outcome>
      <sec_outcome>Assessment of Observed Changes of Self Care Behaviors. Timepoint: 3 Months After Intervention. Method of measurement: Questionnaire and Observation.</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 of Zanjan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2014-05-31</approval_date>
        <contact_name>Ethics Committee of Zanjan University of Medical Sciences</contact_name>
        <contact_address>University of Medical Sciences, Azadi Sq, Zanjan, Iran Zanjan  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
