<?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>IRCT20191223045868N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-05-27</date_registration>
      <primary_sponsor>Gonabad University of Medical Sciences</primary_sponsor>
      <public_title>Evaluation of follow-up nurse plan and its effect on disease severity and dyspnea in patients with chronic obstructive pulmonary disease (COPD)</public_title>
      <acronym></acronym>
      <scientific_title>Evaluation of follow-up nurse plan and its effect on disease severity and dyspnea in patients with chronic obstructive pulmonary disease (COPD)</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-06-10</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>88</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/63658</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Health service research, Randomization description: Random permutation blocks of sizes 2 and 4 will be used for randomization. The analyzer will determine the randomization list based on a web-based randomization program. The allocation will be concealed using opaque sealed envelopes with a random sequence, Blinding description: Blinding will be done for the data analyzer. For the study groups, A and B codes are considered, and the data analyzer is not told the type of intervention.</study_design>
      <phase>N/A</phase>
      <hc_freetext>chronic obstructive pulmonary disease.</hc_freetext>
      <i_freetext>Intervention 1: The intervention group: The follow-up nurse care plan for the intervention group includes: 1- Safe discharge procedures; 2- Introduce the patient to the follow-up nurse and send a summary of the patient history; 3- Initial evaluation of the patient by the nurse to continue the necessary training after discharge and 4- The main phase of follow-up, which will be called to the patient by phone 3 to 7 days after discharge according on the checklist. Then the nurse introduces him/herself, the appropriate follow-up is performed based on the relevant checklist, and recommendations are offered if the patient requires additional training. Also, if the patient needs support resources such as outpatient clinics, hospital self-care clinics, health centers, psychologists, addiction and smoking cessation centers, nutrition counselors, and home care centers, will refer the patient to the mentioned institutions. The frequency of follow-up of patients is determined based on the severity of the disease and the symptoms from three days to three months after discharge as follows: 1. The "Green area": once a month; 2. The "Yellow area": once a week; 3. The "Red area": Advising to go to the hospital emergency department immediately; follow-up by phone up to 6 hours later; follow-up twice a week after discharge from the hospital until they will be set at the "Green area". Note: The relevant doctor's order could determine the frequency of follow-up. Intervention 2: Control group: The control group will receive routine hospital training and follow-up. In order to preserve ethics, at least one routine follow-up will be done in the control 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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is There is no more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Elham Saberi Noghabi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Parstar Ave., Gonabad University of Medical Sciences</address>
        <city>Gonabad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9691793718</zip>
        <telephone>+98 51 5722 3028</telephone>
        <email>saberi.e@gmu.ac.ir</email>
        <affiliation>Gonabad University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Elham Saberi Noghabi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Parstar St., Gonabad University of Medical Sciences</address>
        <city>Gonabad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9691793718</zip>
        <telephone>+98 51 5722 3028</telephone>
        <email>saberi.e@gmu.ac.ir</email>
        <affiliation>Gonabad University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients with definitive diagnosis of COPD by a specialist
Referring to the hospital's self-care and follow-up unit after discharge
Being conscious
Moderate to severe shortness of breath (Shortness of breath score more than 3 on the Borg scale)
Informed consent
Resident of Gonabad city
Access to landline or mobile</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Speech, hearing, and vision disorders and the disability to understand and answer questions
History of mental illness based on self-reporting or patient records data</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>J44.9</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Chronic obstructive pulmonary disease, unspecified</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>The intervention group: The follow-up nurse care plan for the intervention group includes: 1- Safe discharge procedures; 2- Introduce the patient to the follow-up nurse and send a summary of the patient history; 3- Initial evaluation of the patient by the nurse to continue the necessary training after discharge and 4- The main phase of follow-up, which will be called to the patient by phone 3 to 7 days after discharge according on the checklist. Then the nurse introduces him/herself, the appropriate follow-up is performed based on the relevant checklist, and recommendations are offered if the patient requires additional training. Also, if the patient needs support resources such as outpatient clinics, hospital self-care clinics, health centers, psychologists, addiction and smoking cessation centers, nutrition counselors, and home care centers, will refer the patient to the mentioned institutions. The frequency of follow-up of patients is determined based on the severity of the disease and the symptoms from three days to three months after discharge as follows: 1. The "Green area": once a month; 2. The "Yellow area": once a week; 3. The "Red area": Advising to go to the hospital emergency department immediately; follow-up by phone up to 6 hours later; follow-up twice a week after discharge from the hospital until they will be set at the "Green area". Note: The relevant doctor's order could determine the frequency of follow-up.</i_keyword>
      <i_keyword>Control group: The control group will receive routine hospital training and follow-up. In order to preserve ethics, at least one routine follow-up will be done in the control group.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Disease severity. Timepoint: Before and three months after intervention. Method of measurement: COPD Assessment Test (CAT).</prim_outcome>
      <prim_outcome>ِDyspnea. Timepoint: Before and three months after intervention. Method of measurement: Borg scale.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Satisfaction of patients. Timepoint: Three months after intervention. Method of measurement: percentage- questionnaire.</sec_outcome>
      <sec_outcome>Percentage of unscheduled referrals of discharged patients to hospital emergencies. Timepoint: Three months after intervention. Method of measurement: Hospital file.</sec_outcome>
      <sec_outcome>Physical complications after discharge in relation to self-care at home. Timepoint: Three months after intervention. Method of measurement: Percentage of physical complications-questionnaire.</sec_outcome>
      <sec_outcome>Re-hospitalization after discharge. Timepoint: Three months after intervention. Method of measurement: Percentage of Re-hospitalization after discharge-questionnaire.</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>Gonabad University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-04-11</approval_date>
        <contact_name>Research Ethics Committee of Gonabad University of Medical Sciences</contact_name>
        <contact_address>Gonabad University of Medical Sciences, Asian Road Border Gonabad Razavi Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
