<?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>IRCT20180227038888N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-09-13</date_registration>
      <primary_sponsor>Artesh University of Medical Sciences</primary_sponsor>
      <public_title>The Effect of Cooperative Care Model on Mental Health of MS Patients</public_title>
      <acronym></acronym>
      <scientific_title>The effect of participatory care model training on mental health of patients with multiple sclerosis</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-03-06</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>100</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/29934</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: In order to intervene, qualified individuals will be divided into two groups of control and test by quasi-random method with a table, Blinding description: Thus, in analyzing the scores for the control and control groups, the group code is unknown to the analyst. It is also blinded by a person who intervenes with a separate assessor.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Multiple Sclerosis.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: This study is a clinical trial study. Conditions are divided into two groups of control and test by semi-random method. Data collection tools include demographic information questionnaire and general health questionnaire. Using the demographic questionnaire, variables such as age, sex, marital status, level of education, age of diagnosis, history of other diseases and family status are collected. After completing the questionnaires in both groups, the experimental group is involved in an intervention that the participatory care model is implemented in this group and in the control group no intervention is performed by researchers.How to intervene and implement the participatory care model:1. Motivation stage: The purpose of this stage is to motivate the client. This stage was performed by the research team (one neurologist, one clinical psychologist and two nurses. In this stage (the first session for 2 hours) the patients were explained about the research process in the intervention group. Patients were identified by taking a history and paraclinical examination, which led to a list of problems in the field of treatment and care in three areas of lack of health behaviors, lack of diet and inability to control the psychological problems of the disease. The active participation of research team members (according to their areas of responsibility) and patients was discussed.2. Preparation stage: In this stage (second session for one hour), the research team explained the nature of the visits (training and follow-up sessions), the goals and duration of the visits to the patients in the intervention group and the training schedule was presented to them.3. Involvement phase (implementation): This phase included three rounds of educational participation visits and two rounds of follow-up partnerships conducted by the research team.In the participatory educational phase, three visits were made (each visit lasting 50 to 70 minutes with a two-week interval between visits). The first visit was in the nature of disease and treatment, the second visit was in the field of diet and activity, the third visit was in the field of psychological issues. In each visit, the materials were simply presented to the patients by the research team (according to the areas of responsibility) in the form of lectures, PowerPoint, pamphlets and questions and answers. In the participation phase, two visits were followed (each visit for 40-50 minutes with an interval of two weeks). These visits, while examining the problems of the clients, the positive and negative results of the educational actions and previous actions were reviewed and reviewed, and the necessary instructions were provided to correct the objections.4. Evaluation stage: Stage evaluations were performed at the beginning and end of each visit by the research team. In the final evaluation (for 50-70 minutes) to assess the effect of implementing the participatory care model on patients' mental health, three months later, the GHQ-28 questionnaire was measured in the intervention group. Then the same method of assessment and evaluation was performed for the control group simultaneously. Intervention 2: Control group: The control group received routine care, and the researchers did not take any intervention on 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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
n order to access the topics mentioned above, we will only publish general information and, subject to observance of the information of the participants, there will be no access to the information of each individual participant in the study. The informed consent form, the clinical report report, and the study protocol after the completion of the project will be available at the Vice-Chancellor for Research and Technology of the University of Medical Sciences, and there will be no time limits.

When:
Starting data access will be possible 4 months after the results are printed

To whom:
For optimal and practical use of documentation for stepping up MS patients, there will be opportunities for academic and non-academic researchers.

Conditions:
Except for the staff of the Vice-Chancellor of Research and Technology of the University of Medical Sciences, no other person will be allowed access to unidentifiable data.
Requirements for submitting a request for access to data:
1. Researchers working in the treatment and rehabilitation of MS patients
2 MSs for exploitation and use in the treatment and rehabilitation of MS patients

Where to obtain:
Tehran, Fate mi Crossroads, Col. Etemadzadeh,    aja University of Medical Sciences, Research and Technology

How to obtain:
Referring to the Vice-Chancellor for Research and Technology of the University of Medical Sciences and the application form for consideration, which will be made available to the vice-president after examination by the deputy.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Saeed Nazari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>College Nursing Army,Shariati street kaj street,Tehran, Iran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1654883859</zip>
        <telephone>+98 21 7739 2944</telephone>
        <email>Saeed.Nazari93@yahoo.com</email>
        <affiliation>Artesh University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Saeed Nazari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Nursing, Shariati St. Kay Street,Tehran, Iran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1654883859</zip>
        <telephone>+98 21 7739 2944</telephone>
        <email>Saeed.Nazri93@yahoo.com</email>
        <affiliation>Artesh University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>• Definition of MS based on para clinical examinations 
active casework in the MS Society of Tehran
The ability to communicate verbally
Encouraging literacy at least write and read.</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>• Cognitive and mental illnesses (anxiety disorders, depression, obsessive-compulsive disorder, bipolar disorder, psychotic disorders)•
Patient's unwillingness to continue cooperation or failure to complete research tools.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>G35-G37</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Demyelinating diseases of the central nervous system</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: This study is a clinical trial study. Conditions are divided into two groups of control and test by semi-random method. Data collection tools include demographic information questionnaire and general health questionnaire. Using the demographic questionnaire, variables such as age, sex, marital status, level of education, age of diagnosis, history of other diseases and family status are collected. After completing the questionnaires in both groups, the experimental group is involved in an intervention that the participatory care model is implemented in this group and in the control group no intervention is performed by researchers.How to intervene and implement the participatory care model:1. Motivation stage: The purpose of this stage is to motivate the client. This stage was performed by the research team (one neurologist, one clinical psychologist and two nurses. In this stage (the first session for 2 hours) the patients were explained about the research process in the intervention group. Patients were identified by taking a history and paraclinical examination, which led to a list of problems in the field of treatment and care in three areas of lack of health behaviors, lack of diet and inability to control the psychological problems of the disease. The active participation of research team members (according to their areas of responsibility) and patients was discussed.2. Preparation stage: In this stage (second session for one hour), the research team explained the nature of the visits (training and follow-up sessions), the goals and duration of the visits to the patients in the intervention group and the training schedule was presented to them.3. Involvement phase (implementation): This phase included three rounds of educational participation visits and two rounds of follow-up partnerships conducted by the research team.In the participatory educational phase, three visits were made (each visit lasting 50 to 70 minutes with a two-week interval between visits). The first visit was in the nature of disease and treatment, the second visit was in the field of diet and activity, the third visit was in the field of psychological issues. In each visit, the materials were simply presented to the patients by the research team (according to the areas of responsibility) in the form of lectures, PowerPoint, pamphlets and questions and answers. In the participation phase, two visits were followed (each visit for 40-50 minutes with an interval of two weeks). These visits, while examining the problems of the clients, the positive and negative results of the educational actions and previous actions were reviewed and reviewed, and the necessary instructions were provided to correct the objections.4. Evaluation stage: Stage evaluations were performed at the beginning and end of each visit by the research team. In the final evaluation (for 50-70 minutes) to assess the effect of implementing the participatory care model on patients' mental health, three months later, the GHQ-28 questionnaire was measured in the intervention group. Then the same method of assessment and evaluation was performed for the control group simultaneously.</i_keyword>
      <i_keyword>Control group: The control group received routine care, and the researchers did not take any intervention on the control group</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Mental Health. Timepoint: The mental health is measured pre-test before intervention with the GHQ slider, and after the end of the intervention, the mental health is measured again with the GHQ questionnaire. Method of measurement: General mental health questionnaire(GHQ).</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>Artesh University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-02-25</approval_date>
        <contact_name>The Ethics Committee of the University of Medical Sciences aja</contact_name>
        <contact_address>No.77,Tehran pars Fatahi street, Tehran, Iran Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
