<?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>IRCT20190127042506N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-01-08</date_registration>
      <primary_sponsor>Jahrom University of Medical Sciences</primary_sponsor>
      <public_title>The Comparison of the Effect of Self-Care Education Based on Team Members Teaching Design and lecture on Quality of Life and Self-efficacy in Patients with Multiple Sclerosis</public_title>
      <acronym></acronym>
      <scientific_title>The Comparison of the Effect of Self-Care Education Based on Team Members Teaching Design and lecture on Quality of Life and Self-efficacy in Patients with Multiple Sclerosis</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-02-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/37221</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Using computer and randomly assigned patients in one of the three groups of self-care education based on team members (intervention), self-care education is based on lecture (intervention) and control group. In random assignment, each patient is code-fed through a computer system, randomly, code one in the self-care training group based on team members (intervention), code 2 in the self-care education group based on lecture (intervention), and Code three is in the control group.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Multiple Sclerosis.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Self-Care Education Based on Team Members Teaching Design:The education plan will be held for 4-6 sessions per hour in accordance with the educational needs. The number of sessions may be more or less relevant to educational needs. 1. The patients will be divided into four teams of five people from a few days ago.2. The researcher will prepare a self-care education based on the outcome of the need assessment and share it in equal amounts and will be distributed among all patients one week before and they will be required to read the content in advance to expedite their implementation.3. On the day of the performance, according to the previous division of the members, the first persons of each of the four teams in one category, the second team of each team in a category and the third team of each team in another group, and so on, the fourth and fifth teams of each team Will be in another category. In fact, there will be four groups of five, each with a single item in their main teams.4. Then, patients are asked to discuss, discuss, and understand the contents of all five subjects with the same content in each of the categories for 10 minutes.5. After completing the first stage, all members of the team will return to their main teams and, for 10-15 minutes, they will provide their own materials in their teams, as well as ask questions and answer questions.6. At the end of the summary, the questions will be answered by the researcher. Intervention 2: Intervention group:   Effect of Self-Care Education Based on  lecture:The education plan will be held for 4-6 sessions per hour in accordance with the educational needs. The number of sessions may be more or less relevant to educational needs.Teaching in the lecture group will include presenting the Content by lecture with questions and answers, summarizing the Contents and answering the questions by the researcher. Intervention 3: Control group: They will not be given to the control group during the study, but in order to comply with the research ethics, after the patients completed the post-intervention questionnaire, for the control group the self-care education program was more efficiently based on the results of the research , Will be done by the researcher.</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 No more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr Ali Dehghani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Ostad Motahari Ave</address>
        <city>Jahrom</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7414846199</zip>
        <telephone>+98 71 5434 1501</telephone>
        <email>ali.dehghani2000@gmail.com</email>
        <affiliation>Jahrom University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr Ali Dehghani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>ostad motahari Ave</address>
        <city>jahrom</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7414846199</zip>
        <telephone>+98 71 5434 1501</telephone>
        <email>ali.dehghani@gmail.com</email>
        <affiliation>Jahrom University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>1. The patient is informed to participate in the study of satisfaction.
A definitive diagnosis of MS by a neurologist.
Patients aged 18-60 years.
Have literacy to read and write
Not in the acute phase of the disease and at least 6 weeks after the last relapse of the disease
Have the ability to take care of yourself
At least 2 years after the first diagnosis of the disease.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Absence of more than 2 sessions during the intervention will exclude them from participating in the study.
Patient for any reason not to continue to participate in the study.
The patient will not be able to implement the self-care program due to the complications of the disease.
During the intervention, there are acute and critical attacks of the disease.
There are other acute illnesses, such as heart disease, kidney, respiratory, digestive and metabolic diseases other than MS.</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>Lifestyle</i_code>
      <i_code>Lifestyle</i_code>
      <i_code>Lifestyle</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Self-Care Education Based on Team Members Teaching Design:The education plan will be held for 4-6 sessions per hour in accordance with the educational needs. The number of sessions may be more or less relevant to educational needs. 1. The patients will be divided into four teams of five people from a few days ago.2. The researcher will prepare a self-care education based on the outcome of the need assessment and share it in equal amounts and will be distributed among all patients one week before and they will be required to read the content in advance to expedite their implementation.3. On the day of the performance, according to the previous division of the members, the first persons of each of the four teams in one category, the second team of each team in a category and the third team of each team in another group, and so on, the fourth and fifth teams of each team Will be in another category. In fact, there will be four groups of five, each with a single item in their main teams.4. Then, patients are asked to discuss, discuss, and understand the contents of all five subjects with the same content in each of the categories for 10 minutes.5. After completing the first stage, all members of the team will return to their main teams and, for 10-15 minutes, they will provide their own materials in their teams, as well as ask questions and answer questions.6. At the end of the summary, the questions will be answered by the researcher.</i_keyword>
      <i_keyword>Intervention group:   Effect of Self-Care Education Based on  lecture:The education plan will be held for 4-6 sessions per hour in accordance with the educational needs. The number of sessions may be more or less relevant to educational needs.Teaching in the lecture group will include presenting the Content by lecture with questions and answers, summarizing the Contents and answering the questions by the researcher.</i_keyword>
      <i_keyword>Control group: They will not be given to the control group during the study, but in order to comply with the research ethics, after the patients completed the post-intervention questionnaire, for the control group the self-care education program was more efficiently based on the results of the research , Will be done by the researcher.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Quality of Life. Timepoint: Before intervention, immediately after intervention, 30 days after intervention. Method of measurement: Standard questionnaire Multiple sclerosis quality of life: MSQOL-54 -Barbara G. Vickrey (1995) University of California, Los Angeles.</prim_outcome>
      <prim_outcome>Self-efficacy. Timepoint: Before intervention, immediately after intervention, 30 days after intervention. Method of measurement: Multiple sclerosis Self-efficacy Scale-Rigby et al. (2003) - England.</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>Jahrom University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-03-13</approval_date>
        <contact_name>Ethics committee of jahrom university of medical sciences</contact_name>
        <contact_address>Motahari Ave Jahrom Fars Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
