<?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>IRCT201506136261N11</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2015-11-04</date_registration>
      <primary_sponsor>Vice Chancellor for research of Shiraz University of Medical Sciences</primary_sponsor>
      <public_title>The impact of hospital-based training to improve the treatment of patients with heart failure</public_title>
      <acronym></acronym>
      <scientific_title>Trial of effect of hospital-based training program to improve self-care behaviors in heart failure patients using the Health Belief Model</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2015-04-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>94</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/6704</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention.</study_design>
      <phase>2</phase>
      <hc_freetext>Condition 1: heart failure. Condition 2: conjestive heart failure. Condition 3: Left ventricular failure. Condition 4: Heart failure, unspecified.</hc_freetext>
      <i_freetext>Intervention 1: Due to ethical considerations regarding the control group to obtain his address, educational booklets and CD with phone and e-mail address to respond to their questions, they will be available after completion of the study. Intervention 2: Educational interventions with scientific content approved by professors are conducted in four sessions. The first session held on admission includes providing the patients with a brief introduction about the study objectives and their conditions, collecting information about their training needs, providing educational pamphlets, and face-to-face training for 10 minutes. The second session held during discharge includes their familiarization with self-care behaviors through face-to-face training for 20 minutes and presentation of educational clips in form of CD. The third session held two weeks after discharge includes questions about performance of the intended behaviors at home, responding to the patients’ questions by meeting them in the clinic (considering the physicians’ visit), and collecting information. Finally, the last training session held at the end of the fifth and sixth weeks after discharge (considering the physicians’ next visit) includes review of the previously learnt issues, question and answer, and problem solving. The patients will be reminded to attend the meeting through making phone calls and sending SMS. This session will be held for groups of 7 to 10 subjects for one hour. The third stage of data collection will be carried out within the ninth and tenth weeks after discharge (considering the physicians’ next visit in the clinic).</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>Dr mohammad Hosein Kaveh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Health- Fatholmobyn alley- Zahra alley- Shiraz- Iran</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7134814336</zip>
        <telephone>+98 71 3725 1001</telephone>
        <email>kaveh@sums.ac.ir</email>
        <affiliation>School of Public Health</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr mohammad Hosein Kaveh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Health- Fatholmobyn alley- Zahra alley- Shiraz- Iran</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7134814336</zip>
        <telephone>+98 71 3725 1001</telephone>
        <email>kaveh@sums.ac.ir</email>
        <affiliation>School of Public Health</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: Patients with heart failure who are literate and able to communicate.&#13;
Exclusion criteria: underlying disease includes chronic kidney disease or diabetes, a degree in medical science, Exclusion of study due to personal reasons or failure to participate in training sessions (over 2 sessions) or exams.</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>150</hc_code>
      <hc_code>150.0</hc_code>
      <hc_code>150.1</hc_code>
      <hc_code>150.9</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Excl.:complicating:•abortion or ectopic or molar pregnancy (O00-O07, O08.8)</hc_keyword>
      <hc_keyword>Congestive heart failure;Congestive heart disease;Right ventricular failure (secondary to left heart failure)</hc_keyword>
      <hc_keyword>Cardiac asthma;Left heart failure;Oedema of lung;Pulmonary oedema(with mention of heart disease NOS or heart failure)</hc_keyword>
      <hc_keyword>Cardiac, heart or myocardial failure NOS</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>N/A</i_code>
      <i_code>Behavior</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Due to ethical considerations regarding the control group to obtain his address, educational booklets and CD with phone and e-mail address to respond to their questions, they will be available after completion of the study.</i_keyword>
      <i_keyword>Educational interventions with scientific content approved by professors are conducted in four sessions. The first session held on admission includes providing the patients with a brief introduction about the study objectives and their conditions, collecting information about their training needs, providing educational pamphlets, and face-to-face training for 10 minutes. The second session held during discharge includes their familiarization with self-care behaviors through face-to-face training for 20 minutes and presentation of educational clips in form of CD. The third session held two weeks after discharge includes questions about performance of the intended behaviors at home, responding to the patients’ questions by meeting them in the clinic (considering the physicians’ visit), and collecting information. Finally, the last training session held at the end of the fifth and sixth weeks after discharge (considering the physicians’ next visit) includes review of the previously learnt issues, question and answer, and problem solving. The patients will be reminded to attend the meeting through making phone calls and sending SMS. This session will be held for groups of 7 to 10 subjects for one hour. The third stage of data collection will be carried out within the ninth and tenth weeks after discharge (considering the physicians’ next visit in the clinic).</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Knowledge. Timepoint: Before the intervention, two weeks and two months after the first intervention. Method of measurement: European Heart Failure Self-care Behaviour questionnaire.</prim_outcome>
      <prim_outcome>Perceived susceptibility. Timepoint: Before the intervention, two weeks and two months after the first intervention. Method of measurement: European Heart Failure Self-care Behaviour questionnaire.</prim_outcome>
      <prim_outcome>Perceived barriers. Timepoint: Before the intervention, two weeks and two months after the first intervention. Method of measurement: European Heart Failure Self-care Behaviour questionnaire.</prim_outcome>
      <prim_outcome>Perceived benefits. Timepoint: Before the intervention, two weeks and two months after the first intervention. Method of measurement: European Heart Failure Self-care Behaviour questionnaire.</prim_outcome>
      <prim_outcome>Perceived severity. Timepoint: Before the intervention, two weeks and two months after the first intervention. Method of measurement: European Heart Failure Self-care Behaviour questionnaire.</prim_outcome>
      <prim_outcome>Efficacy. Timepoint: Before the intervention, two weeks and two months after the first intervention. Method of measurement: European Heart Failure Self-care Behaviour questionnaire.</prim_outcome>
      <prim_outcome>Cues to action. Timepoint: Before the intervention, two weeks and two months after the first intervention. Method of measurement: European Heart Failure Self-care Behaviour questionnaire.</prim_outcome>
      <prim_outcome>Behavior. Timepoint: Before the intervention, two weeks and two months after the first intervention. Method of measurement: European Heart Failure Self-care Behaviour questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>-. Timepoint: -. Method of measurement: -.</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 Shiraz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2015-04-19</approval_date>
        <contact_name>Ethics Committee of Shiraz University of Medical Sciences</contact_name>
        <contact_address>Research Ethics Committee of the Department of Shiraz University of Medical Sciences, 7 floor,  Shiraz University of Medical Sciences, Karim Khan Zand Blvd, Shiraz, Iran Shiraz  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
