<?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>IRCT20210307050608N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-03-14</date_registration>
      <primary_sponsor>Faculty of Psychology and Educational Sciences</primary_sponsor>
      <public_title>Developing a Family-centered Health Program and Comparing its Effectiveness with Cardiac Rehabilitation Program on Biological and Psychological Components in Individuals with Coronary Heart Disease</public_title>
      <acronym></acronym>
      <scientific_title>Developing a Family-centered Health Program and Comparing its Effectiveness with Cardiac Rehabilitation Program on Biological and Psychological Components in Individuals with Coronary Heart Disease</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-01-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>120</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/61870</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, individuals are randomly divided into two groups of intervention and one control group using random number table. In this method, the first selected number (randomly) set in the first intervention group and the next numbers assign to the second intervention and control groups respectively. Intervention group 1 receive drug treatments 8 sessions of Family-centered Health Program, intervention group 2 receive drug treatments and 8 sessions of Cardiac Rehabilitation Program and the third group as the control, only receive drug treatments.</study_design>
      <phase>1</phase>
      <hc_freetext>Coronary Heart Disease.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Drug treatments and 8 sessions of Family-centered Health Program receive 2 to 2.5 hours and one a week. Intervention 2: Intervention group: Drug treatments and 8 sessions of Cardiac Rehabilitation Program receive 2 to 2.5 hours and one a week. Intervention 3: Control group: They only receive drug treatment.</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:
All related data to participants are shared after hiding patient's name.

When:
The period of access to the present research data will be available 6 months after publication of the research results in the form of research articles.

To whom:
The present study data will be available only to researchers working in the academic and scientific institutions.

Conditions:
The output of statistical analysis will be available

Where to obtain:
Applicants can apply for documentation and data via email at negin.dorri@ut.ac.ir

How to obtain:
After completion of the research and publication of the extracted articles, it will be available for a maximum 6 months later.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Negin Dorri</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Number 3- Doulatshahi Ave- Ehteshamie Street- Darrus- Pasdaran Street Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1944965711</zip>
        <telephone>+98 21 2254 0944</telephone>
        <email>negin.dorri@ut.ac.ir</email>
        <affiliation>University of Tehran Kish International Campus Branch</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Negin Dorri</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Number 3- Doulatshahi Ave- Ehteshamie Street- Darrus- Pasdaran Street Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1944965711</zip>
        <telephone>+98 21 2254 0944</telephone>
        <email>negin.dorri@ut.ac.ir</email>
        <affiliation>University of Tehran Kish International Campus Branch</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>The criteria for admitting the subjects in this study include:-	Diagnosis of coronary heart disease patients.
-	Education level of junior high school or above
-	40 to 65 years of age
-	No history of  hospitalization in psychiatric hospitals
- History of Percutaneous Coronary Intervention
-	Being married
-	Willingness to participate in the study</inclusion_criteria>
      <agemin>40 years</agemin>
      <agemax>65 years</agemax>
      <gender>Male</gender>
      <exclusion_criteria>The exclusion criteria for the experimental group include                                                          	Reluctance to continue attending the intervention sessions
-	Patients with acute myocardial infarction or acute coronary syndrome
-	History of Coronary Artery Bypass Grafting (CABG)
-	History of inflammatory diseases such as collagen vascular disease, avascular necrosis, and chronic infectious diseases
-	Primary Percutaneous Coronary Intervention</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>I25.11</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Atherosclerotic heart disease of native coronary artery with angina pectoris</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Diagnosis</i_code>
      <i_code>Diagnosis</i_code>
      <i_code>Diagnosis</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Drug treatments and 8 sessions of Family-centered Health Program receive 2 to 2.5 hours and one a week.</i_keyword>
      <i_keyword>Intervention group: Drug treatments and 8 sessions of Cardiac Rehabilitation Program receive 2 to 2.5 hours and one a week.</i_keyword>
      <i_keyword>Control group: They only receive drug treatment.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The effectiveness of Family-centered health program Blood Pressure. Timepoint: Before an intervention, immediately after the intervention, 3 months after the end of intervention. Method of measurement: In this study, patients with coronary heart disease (CHD) will be identified by cardiologists.</prim_outcome>
      <prim_outcome>The effectiveness of Family-centered health program in Body Mass Index. Timepoint: Before an intervention, immediately after the intervention, 3 months after the end of intervention. Method of measurement: BMI is weight in kilograms divided by height in meters squared. Weight will be measured using a digital scale with 100 gram accuracy, and height will be measured accurately using a non-stretching tape measure with 0.5 accuracy.</prim_outcome>
      <prim_outcome>The effectiveness of Family-centered health program  in Awareness, attitudes, and adherence to self-care behaviors. Timepoint: Before an intervention, immediately after the intervention, 3 months after the end of intervention. Method of measurement: In this study, self-care will be determined based on the subject's score on the Health Behavior Scale (Conn et al., 1991).</prim_outcome>
      <prim_outcome>The effectiveness of Family-centered health program model in Health-related quality of life. Timepoint: Before an intervention, immediately after the intervention, 3 months after the end of intervention. Method of measurement: In this study, health-related quality of life will be determined based on the subject's score in the Health-Related Quality of Life Scale.</prim_outcome>
      <prim_outcome>The effectiveness of Family-centered health program model on depression, Anxiety and Stress. Timepoint: Before an intervention, immediately after the intervention, 3 months after the end of intervention. Method of measurement: In this study, depression, Anxiety and Stress level will be determined based on t The Depression, Anxiety and Stress Scale - 21 Items.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Heart Rate. Timepoint: Before an intervention, immediately after the intervention, 3 months after the end of intervention. Method of measurement: In this study, heart rate will be determined by heart rate monitor device.</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>Faculty of Psychology and Educational Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-09-25</approval_date>
        <contact_name>Faculty of Psychology and Educational Sciences</contact_name>
        <contact_address>No. 3. Doulatshahi Ave., Rastvan Ave., Darrus., Pasdaran Ave. Tehran Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
