<?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>IRCT20230715058789N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-09-30</date_registration>
      <primary_sponsor>Ahvaz University of Medical Sciences</primary_sponsor>
      <public_title>The effect of self-management training program on self-efficacy of disease management and quality of life of patients with scleroderma</public_title>
      <acronym></acronym>
      <scientific_title>The effect of self-management training program on self-efficacy of disease management and quality of life of patients with scleroderma</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-09-16</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>64</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/72511</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: The sampling method will be random and 16 blocks of 4. The randomization unit is individual and randomization will be done using a table of random numbers.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Scleroderma.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: The intervention is in 6 sessions of 60-75 minutes (self-management) and each session includes three parts reviewing the educational content presented in the previous session, including patients' questions and sharing their experiences, as well as presenting a new topic (40-45 minutes), drawing goals. Training and discussion will be about achieving the goal and progress towards the goals related to the sessions (20-25 minutes) and giving assignments for the next session (5-10 minutes), which will be held once a week. Intervention 2: Control group: This group will receive routine care and treatments, and before the intervention, after the intervention and three months after the intervention of the experimental group, the research questionnaires will be filled by the researcher's interview and questions and answers from the samples of the control group. According to the ethical standards of the research, the self-management program implemented in the intervention group will be given to the control group in the form of a booklet and after the questionnaires are filled by the control group in three months after the intervention.</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 further information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mohammad Sadegh Hallaj</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Golestan Blvd</address>
        <city>Ahvaz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>15794-61357</zip>
        <telephone>+98 61 3314 0000</telephone>
        <email>hallaj.ms@ajums.ac.ir</email>
        <affiliation>Ahvaz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mohammad Sadegh Hallaj</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Golestan Blvd</address>
        <city>Ahvaz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>15794-61357</zip>
        <telephone>۳۳۱۴۰۰۰۰ - 06133140000</telephone>
        <email>hallaj.ms@ajums.ac.ir</email>
        <affiliation>Ahvaz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Diagnosis of scleroderma disease based on classification indices of the American University of Rheumatology and its evaluation and confirmation by a rheumatologist
Age equal to or greater than 18 years
Ability to communicate in Farsi
Non-diagnosis of mental disorders based on the statement of the patient and family
No use of psychoactive drugs in the last three months
Ability to answer questions
Failure to participate in any self-management or rehabilitation program within the past three months
More than one year has passed since the disease</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Scleroderma patients hospitalized in wards
Simultaneously suffering from other musculoskeletal diseases such as lupus, rheumatoid arthritis, Behcet's syndrome, etc.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M00-M99</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Diseases of the musculoskeletal system and connective tissue</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: The intervention is in 6 sessions of 60-75 minutes (self-management) and each session includes three parts reviewing the educational content presented in the previous session, including patients' questions and sharing their experiences, as well as presenting a new topic (40-45 minutes), drawing goals. Training and discussion will be about achieving the goal and progress towards the goals related to the sessions (20-25 minutes) and giving assignments for the next session (5-10 minutes), which will be held once a week.</i_keyword>
      <i_keyword>Control group: This group will receive routine care and treatments, and before the intervention, after the intervention and three months after the intervention of the experimental group, the research questionnaires will be filled by the researcher's interview and questions and answers from the samples of the control group. According to the ethical standards of the research, the self-management program implemented in the intervention group will be given to the control group in the form of a booklet and after the questionnaires are filled by the control group in three months after the intervention.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The self-efficacy  of disease management score in the Self-Efficacy for Managing Chronic Disease questionnaire. Timepoint: Before the start of the intervention, after the end of the intervention and three months after the end of the intervention. Method of measurement: Self-Efficacy for Managing Chronic Disease Questionnaire.</prim_outcome>
      <prim_outcome>The quality of life score in the Systemic Sclerosis Quality of Life Questionnaire. Timepoint: Before the start of the intervention, after the end of the intervention and three months after the end of the intervention. Method of measurement: Systemic Sclerosis Quality of Life 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>Ahvaz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-08-19</approval_date>
        <contact_name>Ethics Committee of Jundi Shapur Ahvaz University of Medical Sciences</contact_name>
        <contact_address>Ahvaz, Golestan Blvd Ahvaz Khouzestan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
