<?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>IRCT20190305042926N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-03-14</date_registration>
      <primary_sponsor>Birjand University of Medical Sciences</primary_sponsor>
      <public_title>The impacts of a peer-led and a nurse-led self-management program on the subject well-being</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the impacts of a peer-led and a nurse-led self-management program on the subject well-being of patients with multiple sclerosis</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-12-05</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>84</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/38049</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Health service research, Randomization description: patients who have inclusion criteria will be assigned to the nurse-led and peer-led education groups using a permutation blocking method (quadruple blocks) with the help of random allocation software.</study_design>
      <phase>2-3</phase>
      <hc_freetext>Subjective well-being in multiple sclerosis patients.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: In this study, there are two nurse-led education and peer-led education groups that receive self-management program. For this, in the nurse-led education group, patients will be divided into 2 groups of 10 and 2 groups of 11 people. Then, self-management training sessions will be held by a qualified nurse for each group for 6 sessions of 2 hours each week. At the end of the second week and thereafter also a telephone follow-up on the implementation of the self-management program will be done. Intervention 2: Intervention group: The peer-led education group will be divided into 2 groups of 10 and two groups of 11 people. Then, two leaders will be selected from among patients with multiple sclerosis. For group leaders, two training sessions on how to meet the goals of peer education and its nature, the principles of communicating with patients, guiding topics in peer education group and etc. will be held. Self-management booklet for multiple sclerosis patients prepared by reputable sources and endorsed by a neurologist will also be available to peer leaders. In the next step, self-management training sessions will be held by peer leaders for each group for 6 sessions of 2 hours each week. At the end of the second week and thereafter also a telephone follow-up on the implementation of the self-management program will be done.</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 "No more information exist".</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Maryam Azizi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Nursing and Midwifery College, Birjand University of Medical Sciences, Ayatollah Ghaffari Street</address>
        <city>Brjand</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۹۷۱۷۸۵۳۵۷۷</zip>
        <telephone>+98 56 3238 1410</telephone>
        <email>azizi.m@bums.ac.ir</email>
        <affiliation>Birjand University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Maryam Azizi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Nursing and Midwifery College, Birjand University of Medical Sciences, Ayatollah Ghaffari Street,</address>
        <city>Birjand</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۹۷۱۷۸۵۳۵۷۷</zip>
        <telephone>+98 985632381410</telephone>
        <email>azizi.m@bums.ac.ir</email>
        <affiliation>Birjand University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria:Satisfaction to participate in the study
Having reading and writing skills
Ages between 20 to 45 years
Spending at least one year of diagnosis of multiple sclerosis by specialist doctors
Not having a history of participation in educational programs related to self-management and psychology
Having a recurrence-remission type disease during the study, approved by a neurologist
Expanded Disability Status Scale be between 0.5 and 5.5</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>45 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Participant dissatisfaction to attend the study
Having other acute or chronic physical, mental or psychiatric disorders such as severe depression.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>G35</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Multiple sclerosis</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>N/A</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: In this study, there are two nurse-led education and peer-led education groups that receive self-management program. For this, in the nurse-led education group, patients will be divided into 2 groups of 10 and 2 groups of 11 people. Then, self-management training sessions will be held by a qualified nurse for each group for 6 sessions of 2 hours each week. At the end of the second week and thereafter also a telephone follow-up on the implementation of the self-management program will be done.</i_keyword>
      <i_keyword>Intervention group: The peer-led education group will be divided into 2 groups of 10 and two groups of 11 people. Then, two leaders will be selected from among patients with multiple sclerosis. For group leaders, two training sessions on how to meet the goals of peer education and its nature, the principles of communicating with patients, guiding topics in peer education group and etc. will be held. Self-management booklet for multiple sclerosis patients prepared by reputable sources and endorsed by a neurologist will also be available to peer leaders. In the next step, self-management training sessions will be held by peer leaders for each group for 6 sessions of 2 hours each week. At the end of the second week and thereafter also a telephone follow-up on the implementation of the self-management program will be done.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Subjective well-being. Timepoint: Before the intervention, immediately at the end of the intervention, as well as two months after the intervention. Method of measurement: In the study of comparison of the impacts of a peer-led and a nurse-led self-management program on the subject well-being of patients with multiple sclerosis for measuring the subjective two well-being, the scale of positive and negative experience balance and satisfaction with life scale (SWLS) will be used.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Life satisfaction. Timepoint: Before the intervention, immediately at the end of the intervention, as well as two months after the intervention. Method of measurement: Satisfaction with life scale (SWLS).</sec_outcome>
      <sec_outcome>Positive and negative affect. Timepoint: Before the intervention, immediately at the end of the intervention, as well as two months after the intervention. Method of measurement: Scale of positive and negative experience balance.</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>Birjand University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-11-03</approval_date>
        <contact_name>کمیته اخلاق دانشگاه علوم پزشکی بیرجند</contact_name>
        <contact_address>خیابان آیت الله غفاری، دانشگاه علوم پزشکی بیرجند Birjand South Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
