<?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>IRCT20151004024342N5</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-09-14</date_registration>
      <primary_sponsor>Mazandaran University of Medical Sciences</primary_sponsor>
      <public_title>"The effect of  education on self -care  of patients and mental health carers"</public_title>
      <acronym></acronym>
      <scientific_title>comparison the effect of teach back and media education on self- care and social support of patients heart failure and mental health of carers</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-05-05</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>150</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/31573</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Other, Purpose: Supportive, Randomization description: Random assignment based on random number table.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Heart Failure،Mental health carers.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group 1: group teach back  (patient-caregiver) post-needle training group, on the first day after admission to the waiting room, a teach back approach was developed in four areas (the nature of the disease, signs and symptoms, treatment, diet and medication, physical activity, and  Sexual and follow-up after discharge will be done for 20-30 minutes within 4 consecutive days, if the patient does not want to be trained, the training will be postponed until the end of the session for 20-15 minutes by check  list of educational content will be asked from the patient and his caregiver, if necessary, the training material will be repeated. Intervention 2: Intervention group 2: In the media group (patient-caregiver), after the needle-setting, the first day after admission to 4 educational fields (the nature of the disease, signs and symptoms, treatment, diet and medication, physical activity and sexuality, and post-clearance follow-up)  4 consecutive days for 20-30 minutes by educational CD and DVD player in the waiting room, and the training will be sent to the carers through the virtual program (telegram). At the end of each training session  A period of 20-15 minutes will be used to check the patient-caregiver's checklist, if necessary, the content will be repeated. Intervention 3: Intervention group3: After the patient's need-caregiver, take care of the patient from the first day after admission for 4 consecutive days in 4 fields of training for 20-30 minutes in the waiting room, through teach back training and electronic file (educational CD).  Became  At the end of each session, the patient-caregiver will be asked for a 20-15 minute checklist.  If necessary, the content will be repeated again.</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 not more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr. Vida Shafi Pour</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Nasibeh School of Nursing and Midwifery ،Vesel Shirazi Street , Amir Mazandarani Boulevar</address>
        <city>sari</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4816715793</zip>
        <telephone>+98 11 3336 7342</telephone>
        <email>v.shafipour@mazums.ac.ir</email>
        <affiliation>Mazandaran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Vida Shafi Pour</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Nasibeh School of Nursing and Midwifery , VesalShirazi Street , Amir Mazandarani Boulevard</address>
        <city>Sari</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4816715793</zip>
        <telephone>+98 11 3336 7342</telephone>
        <email>vhdashafipour@yahoo.com</email>
        <affiliation>Mazandaran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: age more than18،Heart failure according to echo-cardiologist and cardiologist،no experience in attendance,  ability to read and write and understand persian, hearing and defect Cognitive and memory( Alzheimer) , being alert,not having Chronic disease( Cancer ,COPD,  CRF , Cirrhosis, Thyroid), have not mental illness, being telephone and having a DVD  player.
Inclusion caregivers:adults،Living  in the same household as the patient withe HF, ability to reading and writing , ability and willingness to take care of the patient Owning a cellular DVD ,</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Exclusion criteria: not be a member of the healthcare team, unwillingness to continue the study, not contactable  by telephone  and cannot apply attendance , the stressful  event during follow-up and death
Exclusion caregivers: not be a member of the healthcare team , not have mental illness and disability</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Behavior</i_code>
      <i_code>Behavior</i_code>
      <i_code>Behavior</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group 1: group teach back  (patient-caregiver) post-needle training group, on the first day after admission to the waiting room, a teach back approach was developed in four areas (the nature of the disease, signs and symptoms, treatment, diet and medication, physical activity, and  Sexual and follow-up after discharge will be done for 20-30 minutes within 4 consecutive days, if the patient does not want to be trained, the training will be postponed until the end of the session for 20-15 minutes by check  list of educational content will be asked from the patient and his caregiver, if necessary, the training material will be repeated</i_keyword>
      <i_keyword>Intervention group 2: In the media group (patient-caregiver), after the needle-setting, the first day after admission to 4 educational fields (the nature of the disease, signs and symptoms, treatment, diet and medication, physical activity and sexuality, and post-clearance follow-up)  4 consecutive days for 20-30 minutes by educational CD and DVD player in the waiting room, and the training will be sent to the carers through the virtual program (telegram). At the end of each training session  A period of 20-15 minutes will be used to check the patient-caregiver's checklist, if necessary, the content will be repeated</i_keyword>
      <i_keyword>Intervention group3: After the patient's need-caregiver, take care of the patient from the first day after admission for 4 consecutive days in 4 fields of training for 20-30 minutes in the waiting room, through teach back training and electronic file (educational CD).  Became  At the end of each session, the patient-caregiver will be asked for a 20-15 minute checklist.  If necessary, the content will be repeated again</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Self- care. Timepoint: Before training, before discharge, weeks 4 and 8 after discharge. Method of measurement: European Heart Self-care Behavioure Scale(EHScBS).</prim_outcome>
      <prim_outcome>Social support. Timepoint: Before training, before discharge, weeks 4 and 8 after discharge. Method of measurement: Multi-dimensional questionnaire of perceived social support.</prim_outcome>
      <prim_outcome>Mental health. Timepoint: Before training, before discharge, weeks 4 and 8 after discharge. Method of measurement: General Health Questionaire( G.H.Q).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Self care. Timepoint: Before training, before discharge, weeks 4 and 8 after discharge. Method of measurement: European Heart Self-care Behavioure Scale(EHScBS).</sec_outcome>
      <sec_outcome>Social Support. Timepoint: Before training, before discharge, weeks 4 and 8 after discharge. Method of measurement: Multi-dimensional questionnaire of perceived social support.</sec_outcome>
      <sec_outcome>Mental Health. Timepoint: Before training, before discharge, weeks 4 and 8 after discharge. Method of measurement: General Health Questionaire (G.H.Q).</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>Mazandaran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-04-30</approval_date>
        <contact_name>Ethics committee mazandaran University of Medical Sciences</contact_name>
        <contact_address>Moalem  Square Sari Mazandaran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
