<?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>IRCT20220223054111N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2024-02-25</date_registration>
      <primary_sponsor>Mashhad University of Medical Sciences</primary_sponsor>
      <public_title>Investigating the role of education with family cooperation and its impact on the quality of life of pulmonary tuberculosis patients</public_title>
      <acronym>ندارد</acronym>
      <scientific_title>The effect of education based on family participation on the health-related quality of life of patients with pulmonary tuberculosis</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2024-03-02</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>62</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/71905</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Other design features: Allocation concealment method: the method of closed envelopes will be used in such a way that the random sequence generated in the closed envelope will be kept until the entry of each research unit into the study, Randomization description: Randomized Blocked Clustering Design
Equation Design: Cluster
No layers
Type of Trial: Parallel

Individuals who have entry criteria should provide information to randomizer.org website. Initially, the size of each block must be determined. Then, the list of blocks should be written, numbers assigned to them, random numbers selected, and the assignment list to the numbers pre-determined.

Concealment: The batch packet method will be used in a way that the randomly generated sequence will be kept in the batch packet until each research unit enters the study.

To prevent information leakage between intervention and control groups, based on the coordination with the health center, the patient referral program for the control group will be arranged in such a way that they will not be present at the health center during educational classes. Patients in the control and intervention groups are divided in a way that the control group will visit the health center on even days of the week and the intervention group will visit on odd days (Sunday and Tuesday), Blinding description: The analysts of this study perform data analysis without knowledge and bias towards the people allocated in different groups.</study_design>
      <phase>N/A</phase>
      <hc_freetext>pulmonary tuberculosis.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: receiving training with the participation of the patient's caregiver in virtual and face-to-face training sessions (activity, nutrition, familiarity with the disease and complications caused by the disease and its impact on the life of the patient and the family) and receiving 4 motivational text messages with the importance of the role of the family in health and acceleration A short paragraph is sent to the patient's caregiver for 4 weeks during the patient's recovery and taking responsibility. 4 face-to-face sessions for 45-60 minutes and virtual sessions as a separate group of patients and families on the ITA platform in the form of messages, clips and digital educational pamphlets. Intervention 2: Control group: routine care patients of the health center include receiving educational pamphlets and training in the form of an in-person meeting at the beginning of filing and answering the patient's questions when visiting the center to receive oral medications.</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>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is There is no further information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Sadaf Naseri</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Mashhad University of Medical Sciences. Kharazmi Educational Complex. Nursing school</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9137913199</zip>
        <telephone>3-38591511 051</telephone>
        <email>Naseris4001@mums.ac.ir</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Hamid Reza Zendehtalab</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Mashhad University of Medical Sciences. Kharazmi Educational Complex. Nursing school</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9137913199</zip>
        <telephone>+98 51 3859 1511</telephone>
        <email>ZendehtalabHR@mums.ac.ir</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>1-No hospitalization (patient)
2- Two weeks have passed since the start of treatment (patient)
3- The patient has informed consent and completed the form (patient)
4- Must be over 18 years old (patient)
5- Does not have learning problems (auditory-visual-mental) (patient)
6- The patient or family (one person or both) should have a phone and know how to work with it (patient).
7- Be of Iranian origin and have the ability to read and write in Persian (patient)
1- The family has given informed consent and completed the form (family).
2- Must be over 18 years old (family)
3- Does not have learning problems (auditory-visual-mental) (family)
4- The patient or family (one person or both) should have a phone and know how to use it (family).
5- The patient should be satisfied with her presence in the study and be selected as a family member with the patient's agreement
6- Shouldn't be majoring in one of the professions in the field of medical sciences (family)
7- Be of Iranian origin and have the ability to read and write in Persian (family)</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Tuberculosis resistant to treatment and extrapulmonary tuberculosis (patient)
Suffering from a chronic disease (heart-kidney-pulmonary-AIDS) at the same time (patient)
Does not want to participate in the research (patient)
Not able to participate in training sessions for any reason (patient)
Attending another study at the same time (patient)
A family member is suffering from a chronic heart-pulmonary-kidney disease or tuberculosis (family)
Does not want to participate in the research (family)
Does not have the ability to participate in training sessions for any reason (family)
Attending another study at the same time (family)</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>A15</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Respiratory tuberculosis</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: receiving training with the participation of the patient's caregiver in virtual and face-to-face training sessions (activity, nutrition, familiarity with the disease and complications caused by the disease and its impact on the life of the patient and the family) and receiving 4 motivational text messages with the importance of the role of the family in health and acceleration A short paragraph is sent to the patient's caregiver for 4 weeks during the patient's recovery and taking responsibility. 4 face-to-face sessions for 45-60 minutes and virtual sessions as a separate group of patients and families on the ITA platform in the form of messages, clips and digital educational pamphlets.</i_keyword>
      <i_keyword>Control group: routine care patients of the health center include receiving educational pamphlets and training in the form of an in-person meeting at the beginning of filing and answering the patient's questions when visiting the center to receive oral medications.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Quality of life related to the health of patients with pulmonary tuberculosis. Timepoint: before the intervention and one month after the intervention. Method of measurement: Questionnaire of the quality of life of patients with pulmonary tuberculosis.</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>Mashhad University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-07-10</approval_date>
        <contact_name>Ethics Committee of Mashhad Nursing and Midwifery Faculty</contact_name>
        <contact_address>Mashhad University of Medical Sciences, Shahid Kharazmi Educational Complex, School of Nursing Mashhad Razavi Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
