<?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>IRCT20160704028781N4</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-05-14</date_registration>
      <primary_sponsor>Tehran University of Medical Sciences</primary_sponsor>
      <public_title>The effect of self-management on anxiety and depression of people with chronic obstructive pulmonary disease</public_title>
      <acronym></acronym>
      <scientific_title>The effect of self-management program on anxiety and depression of people with chronic obstructive pulmonary disease</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-06-09</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>100</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/47488</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Allocation of samples in groups will be by random blocks without being replaced  in each center. For this purpose, first the letter A for the control group and the letter B for the intervention group are considered and different modes of the two groups are written on the cards and each of them is placed in a closed and opaque envelope. These envelopes are placed in a box and before selecting the card, the researcher does not know the participants  will be palace in what group. The statistician (unaware of the study and the groups) with picking up one of the envelopes from the box, will  determines  the patients entering the study will be in which group, respectively. This process is continued until all the cards are taken out of the box and the cards are returned to the box again and this random selection is repeated to provide the desired sample size. To cover the random allocation, the blocks with different numbers will be used, ie six blocks and two blocks will be entered into the blocks. The six blocks can be a combination of ABBABA and so on. Double blocks can also include AB, BA, Blinding description: Outcome evaluators and data analysts are unaware of the allocation of study groups.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Chronic obstructive pulmonary disease.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: The researcher will educates the self-management skills to the intervention group members. In this group, the education will be given face-to-face. Educational aids such as displaying images and videos on a laptop or mobile phone and various forms of pills and inhalers will also be used for training. Educational content includes self-management training for chronic obstructive pulmonary disease, which includes introducing the patient, introducing and expressing the importance of self-management, drug information required in this disease, prevention and management of relapses, exercise and physical activity in the disease, reduction methods. Shortness of breath, energy-saving techniques, airway cleansing techniques, and proper nutrition in chronic obstructive pulmonary disease. The content of the training program will be guided by the guidelines for patients with chronic lung obstruction written by the Australian Lung Association, which has been approved by faculty members of the Department of Surgery, School of Nursing and Midwifery, Iran. The number of education sessions will include four two-hour sessions on consecutive days. After the first session in each session, first, the contents of the previous session will be reviewed for 30 minutes and answer the patients' questions, and then new content will be presented. Intervention group members will be contacted every two weeks to ensure that they perform the self-management interventions correctly. Intervention 2: Control group: They will only receive routine care and will not receive any additional education.</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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is Is confidential</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Farshad Heidari-Beni</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Nursing Midwifery ,Tehran University of Medical Sciences, Nosrat st. Tohid sq. Tehran I.IRAN</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>141973317</zip>
        <telephone>+98 21 6691 4368</telephone>
        <email>Heidarifarshad70@yahoo.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr Nahid Dehghan Nayeri</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Nursing Midwifery ,Tehran University of Medical Sciences, Nosrat st. Tohid sq. Tehran I.IRAN</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>141973317</zip>
        <telephone>+98 21 6691 4368</telephone>
        <email>nahid.nayeri@gmail.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Confirmation of the disease by the specialist physician
having the ability to understand and speak and read and write in Persian
having the physical ability to interview and complete the questionnaire
not participating in previous self-management programs for chronic obstructive pulmonary disease
lack of hearing problems and problems Disruption of communication
non-use of anti-anxiety or anti-depressant drugs
45 to 70 years age</inclusion_criteria>
      <agemin>45 years</agemin>
      <agemax>70 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Having a life-threatening illness</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>J44</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Other chronic obstructive pulmonary disease</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: The researcher will educates the self-management skills to the intervention group members. In this group, the education will be given face-to-face. Educational aids such as displaying images and videos on a laptop or mobile phone and various forms of pills and inhalers will also be used for training. Educational content includes self-management training for chronic obstructive pulmonary disease, which includes introducing the patient, introducing and expressing the importance of self-management, drug information required in this disease, prevention and management of relapses, exercise and physical activity in the disease, reduction methods. Shortness of breath, energy-saving techniques, airway cleansing techniques, and proper nutrition in chronic obstructive pulmonary disease. The content of the training program will be guided by the guidelines for patients with chronic lung obstruction written by the Australian Lung Association, which has been approved by faculty members of the Department of Surgery, School of Nursing and Midwifery, Iran. The number of education sessions will include four two-hour sessions on consecutive days. After the first session in each session, first, the contents of the previous session will be reviewed for 30 minutes and answer the patients' questions, and then new content will be presented. Intervention group members will be contacted every two weeks to ensure that they perform the self-management interventions correctly.</i_keyword>
      <i_keyword>Control group: They will only receive routine care and will not receive any additional education.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The level of depression. Timepoint: Before the intervention, Six months after the intervention and Twelve months after the intervention. Method of measurement: Hospital Anxiety and Depression Questionnaire (HADS).</prim_outcome>
      <prim_outcome>The level of anxiety. Timepoint: Before the intervention, Six months after the intervention and Twelve months after the intervention. Method of measurement: Hospital Anxiety and Depression Questionnaire (HADS).</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>Tehran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-12-05</approval_date>
        <contact_name>Ethics committee of School of Nursing and Midwifery &amp; Rehabilitation - Tehran University of Medical </contact_name>
        <contact_address>School of Nursing Midwifery ,Tehran University of Medical Sciences, Nosrat st. Tohid sq. Tehran I.IRAN Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
