<?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>IRCT20160914029817N7</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-12-17</date_registration>
      <primary_sponsor>Kerman University of Medical Sciences</primary_sponsor>
      <public_title>The effect of family-centered interactive education through internal social network on lifestyle and happiness in patients with acute coronary syndrome</public_title>
      <acronym></acronym>
      <scientific_title>The effect of family-centered interactive education through internal social network on lifestyle and happiness in patients with acute coronary syndrome in hospitals affiliated to Shahid Sadooghi University of Medical Sciences in Yazd in 2018-19</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-12-06</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>96</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/34925</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: First, we will create two groups A and B, which will be controlled by Group B and intervention group A. The allocation of people to the two groups is a permuted random block method and we will have two blocks that are homogeneous within each of the confounding variables, such as age and gender, and in each block, randomly (using a random number table) People are assigned to groups A and B. The allocation of people is double blind, that is, neither the allocator nor the patient knows how to allocate people. The randomized block random block table is given below:
A	B
B	A
A	B
B	B
A	A
B	B
A	A
B	A
B	B
B	B
A	A
B	B
A	A
B	B
B	A
A	A
A	B
A	A
B	B
A	B
B	A
A	B
B	A
A	A
B	A
A	B
B	A
B	B
A	B
B	B
A	A
B	A
A	B
A	B
B	B
A	B
B	A
A	A
B	B
A	A
A	B
B	A
A	B
B	A
A	A
A	B, Blinding description: The allocation of people is double blind, that is, neither the allocator nor the patient knows how to allocate people.In this way, the list is given to one who is not aware of status A and B, and then each patient entered into the study is allocated according to the table and is assigned respectively A and B.</study_design>
      <phase>N/A</phase>
      <hc_freetext>acute coronary syndrome.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: 96 patients simple randomly divided into control and intervention group.First, Walker's Life Style and Oxford Happiness questionnaire will be completed.in addition to receiving routine training during discharge, is sent to a group's internal social network and textual and visual messages. Intervention 2: control group :The control group only receives routine training during discharge.</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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
patient with acute coronary syndrome

When:
starting 9 months after publication

To whom:
available for people working in academic institutions

Conditions:
nursing student and professors

Where to obtain:
email addresses

How to obtain:
At least two weeks

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Fahimeh Shojae Far</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Medicine, Razi Nursing and Midwifery Faculty Primary Highway of Al-Awat Garden</address>
        <city>kerman</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7616913555</zip>
        <telephone>+98 35 3825 5269</telephone>
        <email>fahimehshojaefar@yahoo.com</email>
        <affiliation>Kerman University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Esmat Nuhi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>7 Bagh Allavi Blvd, Kerman University of Medical Sciences</address>
        <city>kerman</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7616913555</zip>
        <telephone>+98 34 3132 5700</telephone>
        <email>e_nuhi@kmu.ac.ir</email>
        <affiliation>Kerman University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>The inclusion criteria for patient consisted of diagnosis of ACS by a cardiologist
&gt;21 years of age
having access to a personal or family mobile phone
being able to read and write and being familiar with Farsi
The inclusion criteria for patient's family consisted of having access to a third person who can type and read the text messages for them and being able to do the daily activities
having access to a personal or family mobile phone
being able to read and write and being familiar with Farsi</inclusion_criteria>
      <agemin>21 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>The exclusion criteria for patient included changing their mobile phone number and not informing the researcher
having any recognized mental illness or intellectual disabilities and motor
encountering physical and mental problems resulting in disability at any stage of the research
The exclusion criteria for  patient's family included Disability and old age
Unfamiliar with the Persian language in reading and writing
The lack of a proper relationship with the patient</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>I24.8</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Other forms of acute ischemic heart disease</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Lifestyle</i_code>
      <i_code>Lifestyle</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: 96 patients simple randomly divided into control and intervention group.First, Walker's Life Style and Oxford Happiness questionnaire will be completed.in addition to receiving routine training during discharge, is sent to a group's internal social network and textual and visual messages.</i_keyword>
      <i_keyword>control group :The control group only receives routine training during discharge.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Lifestyle. Timepoint: Before and three months after intervention. Method of measurement: Walker Life Style questionnaire.</prim_outcome>
      <prim_outcome>Happiness. Timepoint: Before and three months after intervention. Method of measurement: Oxford Happiness questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome></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>Kerman University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-11-21</approval_date>
        <contact_name>Ethics Committee Kerman University of Medical Sciences</contact_name>
        <contact_address>Kerman, the beginning of the Compus University of Medical Sciences, beginning around Seven Gardens Alavi, kerman Boulevard Haft Bagh Alavi, Medical Sciences Campus Kerman Kerman Kerman Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
