<?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>IRCT20231120060120N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2024-02-02</date_registration>
      <primary_sponsor>Zahedan University of Medical Sciences</primary_sponsor>
      <public_title>Effectiveness of supportive educative program on the Burden</public_title>
      <acronym></acronym>
      <scientific_title>Effectiveness of supportive educative program on the Burden in family caregivers of stroke patients</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-10-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/74197</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Supportive, Randomization description: Table of random numbers.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Ischemic stroke.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: In the intervention group, the needs assessment questionnaires, demographic information and disease information and care burden questionnaire are provided to the caregivers of the patients to be completed by them.  In the intervention group, the designed educational program is given to the caregivers of the patients and they are taught.  The method of providing educational content is individually and face-to-face to each caregiver. During each session, the training items will be taught first, then it will be practiced practically with the caregiver, and finally it will be done independently by him and after the assurance of the researcher.  Learning will be provided by the caregiver in the next training and another case. The educational program will be implemented in the form of 6 sessions with the opinion of the patient's caregiver and in a place that is comfortable for him.  6 training sessions will be held, attendance in all sessions is optional, but attendance in sessions where their problem will be known will be mandatory. After three months after the completion of the training, the questionnaires are again given to the caregivers of the patients to be completed. In the control group, the questionnaires are first given to the caregivers of the patients and according to the same routine training that they received in the hospital.  They are not given any other training, and after three months, the questionnaires are provided to the caregivers in the control group to complete.  During this study, the patients are continuously followed up by the researcher, and the researcher is informed about the patient's condition by following up and being with the caregivers and answers the questions and doubts of the caregivers.  In the end, the educational materials will be provided to the control group in order to comply with the ethical principles. Intervention 2: Intervention 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:
The data will be published as an article

When:
3 months

To whom:
Every one

Conditions:
The results will be published in the form of chapter 4 of the thesis and the results of the article

Where to obtain:
chapter 4 of the thesis and the results of the article

How to obtain:
Take a E-mail

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>hanieh dahmardeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Zahedan Meydan Mashahir FacultyOf Nursing and Midwifery</address>
        <city>Zahedan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9816743463</zip>
        <telephone>09805433442481</telephone>
        <email>haniedahmardeh@gmail.com</email>
        <affiliation>Zahedan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Hanieh dahmardeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Zahedan Meydan Mashahir FacultyOf Nursing and Midwifery</address>
        <city>Zahedan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9816743463</zip>
        <telephone>09805433442481</telephone>
        <email>haniedahmardeh@gmail.com</email>
        <affiliation>Zahedan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Entry criteria: (patients) 1- Confirmation of the diagnosis of stroke (of the ischemic type for the first time) by the attending physician 2-Consciousness level (GCS) 11 or higher when they are discharged from the intensive care unit of the ICU) Having a caregiver at home 3- According to the different needs of patients after a stroke, patients will be selected who suffer from problems of lack of self-care in the fields of self-care (such as bathing, feeding, movement problems and inability to move the body, etc.). 4- Patients will be included in the study who are in the age range of 20 years and above (because in addition to elderly people who suffer from strokes due to chronic diseases, one of the types of CVA is due to trauma and accidents and it is possible  involve young people as well) 5-Having a 3rd or 4th grade rating scale within 48 hours after a stroke (the scale for examining the level of functional disability of patients following a stroke, where the patient's disability is graded from 0 to 5) Determining the severity of patients' disability in 72 hours after the onset of stroke: Rankin's standard scale with grades 0-5 Classification of severity of disability is used: Grade zero, the patient has no abnormal neurological symptoms. Grade 1 has disability without significant symptoms.  It means the patient is capable to perform all his normal duties and activities. Grade 2 has mild disability.  It means able to do everything It is not the previous activities, but it is able to take care of itself without the help of others. Grade 3 has moderate disability.  It means that he needs the help of others, but he is able to walk without the help of others. Grade 4 has moderate to severe disability.  That is, he is unable to walk without the help of others. Grade 5 has severe disability.  It means that the patient is always in bed and needs round-the-clock nursing measures. Entry criteria: (careful) Willingness to participate in the study. (Having consent to participate in the study) Caregiver does not have experience working in the therapy team The age of the caregiver should be between 20 and 70 years.  (for the ability to care for a person with a stroke) Do not have a speech or hearing or vision impairment. Be literate in reading and writing. Physically, he should be able to take care of the patient and not have any illness or disorder. Having direct responsibility in patient care for at least 8 hours a day Having a family relationship with the patient, including wife, child, brother, sister Failure to receive payment for care</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>70 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: In the intervention group, the needs assessment questionnaires, demographic information and disease information and care burden questionnaire are provided to the caregivers of the patients to be completed by them.  In the intervention group, the designed educational program is given to the caregivers of the patients and they are taught.  The method of providing educational content is individually and face-to-face to each caregiver. During each session, the training items will be taught first, then it will be practiced practically with the caregiver, and finally it will be done independently by him and after the assurance of the researcher.  Learning will be provided by the caregiver in the next training and another case. The educational program will be implemented in the form of 6 sessions with the opinion of the patient's caregiver and in a place that is comfortable for him.  6 training sessions will be held, attendance in all sessions is optional, but attendance in sessions where their problem will be known will be mandatory. After three months after the completion of the training, the questionnaires are again given to the caregivers of the patients to be completed. In the control group, the questionnaires are first given to the caregivers of the patients and according to the same routine training that they received in the hospital.  They are not given any other training, and after three months, the questionnaires are provided to the caregivers in the control group to complete.  During this study, the patients are continuously followed up by the researcher, and the researcher is informed about the patient's condition by following up and being with the caregivers and answers the questions and doubts of the caregivers.  In the end, the educational materials will be provided to the control group in order to comply with the ethical principles.</i_keyword>
      <i_keyword>Intervention group:</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Supportive educative program. Timepoint: 3 month. Method of measurement: Novak and Gast care pressure questionnaire (1989.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Burden. Timepoint: 3 month. Method of measurement: Novak and Gast care pressure questionnaire (1989.</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>Zahedan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-11-11</approval_date>
        <contact_name>Ethics committee of zahedan University of Medical Sciences</contact_name>
        <contact_address>Zahedan Meydan Mashahir Faculty of Nursing and Midwifery Zahedan Sistan-va-Balouchestan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
