<?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>IRCT2015120120912N4</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2016-03-03</date_registration>
      <primary_sponsor>Vice Chancellor for Research of Isfahan University of Medical Sciences</primary_sponsor>
      <public_title>The effect of cooperation of treatment team and the patient on the quality of life in patients after coronary angioplasty</public_title>
      <acronym>_</acronym>
      <scientific_title>The effect of collaborative care on the quality of life of patients after coronary angioplasty</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2015-04-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>50</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/18463</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Other design features: Table of random numbers.</study_design>
      <phase>2</phase>
      <hc_freetext>patients after coronary angioplasty.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: collaborative treatment program was conducted in 5 group sessions; in a way that 3 educational collaborative care sessions were conducted weekly and 2 collaborative care follow-up sessions were conducted every other week and each session was 45 to 60 minutes. At first, the educational content was prepared by the researcher nurse based on authentic texts and original sources and  in a collaborative session in the presence of the expert physician and the participants, the educational content was represented and the collaborative program was finalized after each participant’s agreement. During the session speech, question and answer and groups and individual discussion were used. After conducting the collaborative program, follow-up was conducted by calling the participants and addressing their questions and problems, as it has been agreed on before. During the first session patients were introduced to their current disease and its threats and complications and appropriate diet and physical activity and the right method of drug consumption for patients with coronary artery disease was explained to them by an expert physician and a nurse through a speech. During the second session, the presented educational content was discussed between the physician and the nurse with participation of the patients and an agreement was reached about the appropriate diet and physical activities and the final program was executed by patients’ opinion. During the third session the presented educational program was discussed between the physician, the nurse and the patients and an agreement was reached about the right method of drug consumption and the final program was executed by patients’ opinion. The collaborative care follow-up sessions were conducted for continuity of the care program and involvement of the patients. Sessions were conducted every other week and twice for each patient. After the collaborative follow-up sessions, patients were followed up for 12 weeks through phone calls and by addressing their questions and problems, as it has been agreed on before. Intervention 2: Control group: two group sessions were conducted to discuss the importance of medication, diet and exercise. sessions were held weekly each lasting 60 minutes.</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>Parastoo Rezapoor</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Isfahan University of Medical Sciences, Hezarjrib Ave, Isfahan</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 31 3792 2950</telephone>
        <email>parastoo_rezapoor@yahoo.com</email>
        <affiliation>Isfahan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mohsen Shahriari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Isfahan University of Medical Sciences, Hezarjrib Ave, Isfahan</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 31 3792 2950</telephone>
        <email>shahriari@nm.mui.ac.ir</email>
        <affiliation>Isfahan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: being aged more than 18  and less than 70 years; being conscious; having the ability to make communication; being aware of their disease; being able to read and write; not having an acute cardiovascular disease, diabetes type 1 and 2, hormone disorders and renal and mental diseases; having appropriate clinical condition according to physician’s diagnosis and not having any constraints for performing the interventions. &#13;
Exclusion criteria: being absent for more than 2 educational sessions for intervention group; die or encounter any problem that would make them unable to continue the study.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>70 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>Z95.5</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Presence of coronary angioplasty implant and graft</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Other</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: collaborative treatment program was conducted in 5 group sessions; in a way that 3 educational collaborative care sessions were conducted weekly and 2 collaborative care follow-up sessions were conducted every other week and each session was 45 to 60 minutes. At first, the educational content was prepared by the researcher nurse based on authentic texts and original sources and  in a collaborative session in the presence of the expert physician and the participants, the educational content was represented and the collaborative program was finalized after each participant’s agreement. During the session speech, question and answer and groups and individual discussion were used. After conducting the collaborative program, follow-up was conducted by calling the participants and addressing their questions and problems, as it has been agreed on before. During the first session patients were introduced to their current disease and its threats and complications and appropriate diet and physical activity and the right method of drug consumption for patients with coronary artery disease was explained to them by an expert physician and a nurse through a speech. During the second session, the presented educational content was discussed between the physician and the nurse with participation of the patients and an agreement was reached about the appropriate diet and physical activities and the final program was executed by patients’ opinion. During the third session the presented educational program was discussed between the physician, the nurse and the patients and an agreement was reached about the right method of drug consumption and the final program was executed by patients’ opinion. The collaborative care follow-up sessions were conducted for continuity of the care program and involvement of the patients. Sessions were conducted every other week and twice for each patient. After the collaborative follow-up sessions, patients were followed up for 12 weeks through phone calls and by addressing their questions and problems, as it has been agreed on before.</i_keyword>
      <i_keyword>Control group: two group sessions were conducted to discuss the importance of medication, diet and exercise. sessions were held weekly each lasting 60 minutes.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Quality of life. Timepoint: Before the intervention and 3 month after intervention. Method of measurement: SF-36 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 Isfahan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2015-05-26</approval_date>
        <contact_name>Ethics committee of  Isfahan University of Medical Sciences</contact_name>
        <contact_address>Isfahan University of Medical Sciences, Hezarjrib Ave, Isfahan Isfahan  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
