<?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>IRCT201101225665N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2011-06-06</date_registration>
      <primary_sponsor>Tabriz Medical Sciense University - Tabriz Nursing and  Midwifery Faculty-Reaserch Deputy</primary_sponsor>
      <public_title>Effect of teaching program on quality of life in heart failure clients</public_title>
      <acronym></acronym>
      <scientific_title>Effect of teaching program based on Roy' s adaptation model on quality of life of clients with heart failure</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2011-02-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>44</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/6177</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention.</study_design>
      <phase>N/A</phase>
      <hc_freetext>heart failure.</hc_freetext>
      <i_freetext>Intervention 1: At first in two groups , the Quality of life and body activity level and interpersonal support will be measured by three tools: Minosuta Quality of life , 6 minute walking Test and Interpersonal Support List, at first and 3 months after intervention. &#13;
The control group During 3 months will receive the usual care and education which is common , and they will not be limited from the routine care.&#13;
/The intervention group besides the usual care and education, at  first two visits will be assessed based on Roy's Assessment form, and their maladaptive behaviors will be determined, then they will receive a teaching booklet based on Roy' s adaptation model and American heart failure association Modules (includes: information about their disease, diet, activity, medications, interpersonal relationship) and they will receive discussion and consult with emphasize on their maladaptive behaviors. They will receive phone calls about the program objectivities and content of study every week, and every 3 week we will visit them and consult about their problems with emphasize on Roy adaptation model and about how much they follow the booklet guidelines. After 3 months the Quality of life and body activity and interpersonal support in two groups will be measured by the same tools (Minosuta Quality of life , 6 minute walking Test and Interpersonal Support List) and at last two groups will compare. Intervention 2: In Control group the Quality of life and Body activity and Inter personal support in will be measured by Minosuta Quality of life and 6 minute walking Test and Interpersonal Support List at first and 3 months after intervention. During 3 months the control group will receive the usual care and teaching and will not limited the routine care.  After 3 months the Quality of life and Body activity and Interpersonal support will be measured and then will compare with intervention group .</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>Mohammad Khajegodari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>5137947977-Nursing and Midwifery Faculty-Tabriz Sharati Jnoobi Ave.</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5137947977</zip>
        <telephone>+98 41 1477 0648</telephone>
        <email>laks@tbzmed.ac.irlak1369@yahoo.com</email>
        <affiliation>Tabriz Medical Science University- Research Deputy</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Sima Lakdizaji</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>5137947977- Nursing and Midwifery Faculty- Sharati Jnoobi Ave.- Tabriz</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5137947977</zip>
        <telephone>+98 41 1477 0648</telephone>
        <email>laks@tbzmed.ac.irlak1369@yahoo.com</email>
        <affiliation>Tabriz Medical Science University- Research Deputy</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>1- clients with heart failure who admitted to special heart clinic&#13;
2- clients who recognised foe at least one month&#13;
3- clients with heart failure in class II or III&#13;
4- clients above 18 and below 75 years old.&#13;
5- consiuse and could communicate&#13;
6- could walking&#13;
exclution criteria:&#13;
1- if clients do not have willing for participation&#13;
2- have any other medical problems&#13;
3- psychological problems or addiction</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>75 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>I50.9</hc_code>
    </health_condition_code>
    <health_condition_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>At first in two groups , the Quality of life and body activity level and interpersonal support will be measured by three tools: Minosuta Quality of life , 6 minute walking Test and Interpersonal Support List, at first and 3 months after intervention. &#13;
The control group During 3 months will receive the usual care and education which is common , and they will not be limited from the routine care.&#13;
/The intervention group besides the usual care and education, at  first two visits will be assessed based on Roy's Assessment form, and their maladaptive behaviors will be determined, then they will receive a teaching booklet based on Roy' s adaptation model and American heart failure association Modules (includes: information about their disease, diet, activity, medications, interpersonal relationship) and they will receive discussion and consult with emphasize on their maladaptive behaviors. They will receive phone calls about the program objectivities and content of study every week, and every 3 week we will visit them and consult about their problems with emphasize on Roy adaptation model and about how much they follow the booklet guidelines. After 3 months the Quality of life and body activity and interpersonal support in two groups will be measured by the same tools (Minosuta Quality of life , 6 minute walking Test and Interpersonal Support List) and at last two groups will compare.</i_keyword>
      <i_keyword>In Control group the Quality of life and Body activity and Inter personal support in will be measured by Minosuta Quality of life and 6 minute walking Test and Interpersonal Support List at first and 3 months after intervention. During 3 months the control group will receive the usual care and teaching and will not limited the routine care.  After 3 months the Quality of life and Body activity and Interpersonal support will be measured and then will compare with intervention group .</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Quality of life. Timepoint: 3 months. Method of measurement: Minosuta living With Heart Failure Questioneir.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Inter personal support. Timepoint: 3 months. Method of measurement: interpersonal support list.</sec_outcome>
      <sec_outcome>Body activities. Timepoint: 3 months. Method of measurement: 6 minute walking test.</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 Medical Sciense University - Tabriz Nursing and  Midwifery Faculty-Reaserch Deputy</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2011-02-19</approval_date>
        <contact_name>Tabriz Medical Science University- Research Deputy-Etics commitee</contact_name>
        <contact_address>Research Deputy- Amoozesh bulding- Tabriz Medical Sciense University- Daneshgah Ave.- Tabriz Tabriz  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
