<?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>IRCT2016052628089N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2016-09-11</date_registration>
      <primary_sponsor>Vice chancellor for research, University of  Social Welfare and Rehabilitation Sciences, Tehran</primary_sponsor>
      <public_title>The  effect  of  self  management  program  on  self  efficacy,  self care     behaviors and  health status in old  patients  with heart  failure</public_title>
      <acronym>CDSM</acronym>
      <scientific_title>The  effect  of  self  management  program  on  self  efficacy,  self care      behaviors and  health status in old  patients  with heart  failure</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2015-09-06</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>90</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/22863</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Supportive, Other design features: In this study, was performed inclusion criteria were randomized into two groups using random blocks 1 and 2  intervention.</study_design>
      <phase>2-3</phase>
      <hc_freetext>Condition 1: Heart Failure. Condition 2: Heart failure. Condition 3: Heart failure.</hc_freetext>
      <i_freetext>Intervention 1: The intervention group 2 (control group) received  only usual care. This group completed  with the group1, in parallel before, after and two months after intervention  self-efficacy , heart failure self-care behaviors and health status questionnaires. At the end of two months of study and after completion of the investigation, according to moral considerations in research  was placed management program to provide training manual intervention group 2. Intervention 2: Chronic disease self-management program schedule at Stanford University. In this study, were divided research unit for random assignment into using random blocks in  two  intervention group 1 (test group) and intervention group 2 (control group). The intervention group 1 was held for the implementation of the program into three sub groups of 15 and self-management program in six weeks and each week a meeting for 90 minutes for each subgroup separately. Education  was  face to face  and group. The content of the program include knowledge of disease, therapies, problem-solving process, diet, exercise, stress control and relaxation. Educational content  were similar for all subgroups in intervention group. The opportunity to implement self-management program at home two months were given to them And were given self-reporting checklist  to them. At this time, the researcher monitored the phone calls of the implementation of the program. The control group received only usual care. At the end of control group also were given an educational booklet.  questionnaires  was completed at three points in time: Before, after and two months after  intervention and the data analyzed.</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>Tayebe Aghamohamadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>CCU-1 Ward, 22 Bahman Hospital, Neyshabour</address>
        <city>Neyshabour</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9313733333</zip>
        <telephone>+98 51 4333 6826</telephone>
        <email>aghamohammadit1@nums.ac.ir; t.aghamohamadi@yahoo.com</email>
        <affiliation>University of Social Welfare  and  Rehabilitation Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Farahnaz Mohammadi Shahbolaghi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>The Department Nursing, University of Welfare and Rehabilitation</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1985713834</zip>
        <telephone>+98 21 2218 0036</telephone>
        <email>f.mohammadi@uswr.ac.ir</email>
        <affiliation>University of Social Welfare  and  Rehabilitation Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: ability to read and write; age 60 years and older; no motor disabilities and handicaps; Class 2 and 3 heart failure; no previous training in the field of self-management; passing at least six months of the disease, willingness to participate in the program. &#13;
Exclusion criteria: severity of the disease; died as a result of illness; unwillingness to continue the program</inclusion_criteria>
      <agemin>60 years</agemin>
      <agemax>92 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_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>Congestive heart failure</hc_keyword>
      <hc_keyword>Left ventricular failure</hc_keyword>
      <hc_keyword>Heart failure, unspecified</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Lifestyle</i_code>
      <i_code>Lifestyle</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>The intervention group 2 (control group) received  only usual care. This group completed  with the group1, in parallel before, after and two months after intervention  self-efficacy , heart failure self-care behaviors and health status questionnaires. At the end of two months of study and after completion of the investigation, according to moral considerations in research  was placed management program to provide training manual intervention group 2.</i_keyword>
      <i_keyword>Chronic disease self-management program schedule at Stanford University. In this study, were divided research unit for random assignment into using random blocks in  two  intervention group 1 (test group) and intervention group 2 (control group). The intervention group 1 was held for the implementation of the program into three sub groups of 15 and self-management program in six weeks and each week a meeting for 90 minutes for each subgroup separately. Education  was  face to face  and group. The content of the program include knowledge of disease, therapies, problem-solving process, diet, exercise, stress control and relaxation. Educational content  were similar for all subgroups in intervention group. The opportunity to implement self-management program at home two months were given to them And were given self-reporting checklist  to them. At this time, the researcher monitored the phone calls of the implementation of the program. The control group received only usual care. At the end of control group also were given an educational booklet.  questionnaires  was completed at three points in time: Before, after and two months after  intervention and the data analyzed.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Self Efficacy. Timepoint: Before, after and two month after intervention. Method of measurement: heart Self-Efficacy Questionnaire, Sullivan.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Self care behaviore. Timepoint: Before, after and two month after intervention. Method of measurement: European questionnaire self-care behaviors in heart failure.</sec_outcome>
      <sec_outcome>Health status. Timepoint: Before, after and two month after intervention. Method of measurement: Health Status Questionnaire cardiomyopathy Kansas City.</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, University of  Social Welfare and Rehabilitation Sciences, Tehran</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2015-05-22</approval_date>
        <contact_name>Ethics Committee of University of Welfare and Rehabilitation Sciences</contact_name>
        <contact_address>University of  Social Welfare and Rehabilitation Sciences, koodakyar Blvd, Daneshjoo Stre, Evin Ave, Tehran. Tehran  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
