<?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>IRCT201107041464N4</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2012-06-05</date_registration>
      <primary_sponsor>Tabriz University of Medical Sciences</primary_sponsor>
      <public_title>The  effect  of  education  on  Self-Care  behaviors &amp;  readmission of  patients  with  heart failure</public_title>
      <acronym></acronym>
      <scientific_title>The  effect   of  Supportive- Educative   interventions   on  Self-Care   behaviors &amp; readmission rates of  patients  with  heart failure</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2011-07-11</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>80</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/740</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive.</study_design>
      <phase>3</phase>
      <hc_freetext>Heart Failure.</hc_freetext>
      <i_freetext>Intervention 1: The present  study was  included  a  two-part intervention.  The first  part  of  the  intervention was included  patient education in  the   intervention group. Patients  in the  intervention  group were educated  by  nurses  who  worked  in  cardiac  wards.  Education had been personalized  for each patient. After determining the learning needs of patients  about heart failure  and according to the  previous information, the educational level and cognitive level of patients,  researcher done the training.  Training performed with the goal of improving self-care behavior such as receiving  proper medical  regimes, fluid  and  sodium restriction, Improving  physical activity, control symptoms and  signs  of  worsening the heart failure to prevent worsening of the disease in the patients with heart failure. Patients&#13;
 and  their families were educated  for an hour. Training was contain information about heart failure definition, signs and symptoms of the disease,  information about the diet, Information about medications,  information about the activities and appropriate  sports. The booklet was given to patients or their families at the time of discharge. The second part of the intervention, was include telephone follow-up of patients after discharge from the hospital. This support was to strengthen the basic education and providing strategies for improvement of patients self-care behaviors. In the first stage of the follow-up phone call  was conducted after  two days of hospital discharge to confirm the patient information and for establishment of the next time of phone contacts. Then, every two weeks  for three months,  the phone calls were conducted in order to support patients in the intervention group. At the end of each month during the period of study phone calls were conducted with patients, in both study groups, in order to obtain information about self-care behaviors, the cost of care, readmission rates  and refer to physician. Intervention 2: Patients in  the control group received  All&#13;
 cares  and  treatments provided by Hospital and  physician  during  the intervention.</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. Vahid zamanzadeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Nursing and Midwifery Scool</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>51745-347</zip>
        <telephone>+98 41 1381 9129</telephone>
        <email>zamanzadeh@tbzmed.ac.ir</email>
        <affiliation>Tabriz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Vahid zamanzadeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Nursing and Midwifery Scool</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>51745347</zip>
        <telephone>+98 41 1381 9129</telephone>
        <email>zamanzadeh@tbzmed.ac.ir</email>
        <affiliation>Tabriz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion Criteria : &#13;
18 years or older patients who were hospitalized because of congestive heart failure; to have echocardiography form (EF  lesser than 40%); talking in Turkish or Persian; consciousness at reception; accessibility after release by phone call; agreement with training at release time and self care pursuit; not to accompany at another study.&#13;
Exclusion Criteria :&#13;
 death of patients; disagreement with continuance of pursuit; long time journey after release from hospital up to 6 months; to have acute and progressive disease other than congestive heart failure and distinguished mental disorder.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>85 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>I50</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Heart Failure</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>The present  study was  included  a  two-part intervention.  The first  part  of  the  intervention was included  patient education in  the   intervention group. Patients  in the  intervention  group were educated  by  nurses  who  worked  in  cardiac  wards.  Education had been personalized  for each patient. After determining the learning needs of patients  about heart failure  and according to the  previous information, the educational level and cognitive level of patients,  researcher done the training.  Training performed with the goal of improving self-care behavior such as receiving  proper medical  regimes, fluid  and  sodium restriction, Improving  physical activity, control symptoms and  signs  of  worsening the heart failure to prevent worsening of the disease in the patients with heart failure. Patients&#13;
 and  their families were educated  for an hour. Training was contain information about heart failure definition, signs and symptoms of the disease,  information about the diet, Information about medications,  information about the activities and appropriate  sports. The booklet was given to patients or their families at the time of discharge. The second part of the intervention, was include telephone follow-up of patients after discharge from the hospital. This support was to strengthen the basic education and providing strategies for improvement of patients self-care behaviors. In the first stage of the follow-up phone call  was conducted after  two days of hospital discharge to confirm the patient information and for establishment of the next time of phone contacts. Then, every two weeks  for three months,  the phone calls were conducted in order to support patients in the intervention group. At the end of each month during the period of study phone calls were conducted with patients, in both study groups, in order to obtain information about self-care behaviors, the cost of care, readmission rates  and refer to physician.</i_keyword>
      <i_keyword>Patients in  the control group received  All&#13;
 cares  and  treatments provided by Hospital and  physician  during  the intervention.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Self-care behavior. Timepoint: each month until three month. Method of measurement: based on self-care behaviour index tools.</prim_outcome>
      <prim_outcome>Readmission. Timepoint: Each month until three month. Method of measurement: Rate of admission to the hospital with worsen of heart failur.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Visit of physician. Timepoint: each month until three month. Method of measurement: rate of referal to the physician fore worsen of heart failur.</sec_outcome>
      <sec_outcome>Costs of treatment. Timepoint: Each month until three month. Method of measurement: Rate of costs for readmissions and visit of physician.</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>Tabriz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2010-08-20</approval_date>
        <contact_name>Ethical Committee of Tabriz University of medical sciences</contact_name>
        <contact_address>Emam Ave Tabriz  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
