<?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>IRCT20230303057597N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-10-25</date_registration>
      <primary_sponsor>Esfahan University of Medical Sciences</primary_sponsor>
      <public_title>Effect of a supportive educational program on the burden of care and quality of life in family care provider</public_title>
      <acronym>COPE</acronym>
      <scientific_title>Investigating The effect of a supportive educational program based on COPE model on the burden of care and quality of life in family care provider with Ischemic Stroke dischared of intensive care units of selected hospitals</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-06-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>32</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/69516</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Supportive, Randomization description: The samples are selected in an easy continuous method from among the family caregivers of patients with ischemic cerebral stroke discharged from the intensive care unit in need of family care who meet the entry criteria for the study. Then they are randomly assigned to two control and test groups. In order to randomly assign the samples using a computerized random number table, a code is first assigned to each of the participants, then the first 32 codes are assigned to the control group and the next 32 codes are assigned to the intervention group.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Ischemic Stroke.</hc_freetext>
      <i_freetext>Intervention group: For the people who entered the intervention group, first a face-to-face meeting will be held at the hospital, where the method of solving the problem will be explained based on the Koop model. In the creativity component, care problems are taught from different perspectives to develop new strategies to solve them. (For example, "I will be creative in my patient's daily activities.") In optimism, families should have a positive but realistic attitude toward the problem-solving process. As much as possible in planning, they convey realistic optimism to the patient (eg, "I believe that daily activities can be done.") In planning, reasonable care goals are set and steps are taken. What is necessary to achieve those goals is determined in advance (for example, "I plan my patient's daily activities so that he can also be present in the crowd."). In professional information, families are taught what nonprofessionals need to know about the nature of the problem, when to seek professional help, and what family caregivers can do on their own to cope (eg, I use available resources). I will use). Then a booklet about common problems and necessary training is given to the caregiver and he is asked to choose a problem and teach how to use the model and booklet to solve the problem. In this meeting, educational needs assessment is done by the individual and the family. The educational content and goals in the first session include: greetings, expressing goals and needs assessment, familiarizing the person with the disease, signs and symptoms, and at the end of the first session, an agreement is made about a phone call with him. Based on the patient's condition, face-to-face sessions will be between one and two hours, and phone sessions will last between 15 and 20 minutes.Three days after the first session, the researcher made a reminder phone call to the caregiver and read the booklet and asked questions about the implementation of the care according to the training program and agreed on a face-to-face meeting with the caregiver at the hospital to review the results of the previous session/fix the problems. be madeIn the second face-to-face meeting on the 16th day, the process is reviewed again and the caregiver is discussed about another problem and the use of models and booklets, and the time of the next phone call with him to teach new educational concepts is determined.In the next phone call, which will be made two days later, the carer's questions will be answered and he will be encouraged to use the model, and the time to complete the questionnaire will be agreed with him one month after the start of the program.The control group only receives hospital training at the time of discharge and follow-ups from the relevant hospital's health education unit, and after one month, the questionnaire is completed for them..</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 There is no further information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Masoumeh Raeesi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 22, No. 4 Alley, Kaveh Ave, Aboureyhan St, Isfahan</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8193761925</zip>
        <telephone>+98 913 227 1978</telephone>
        <email>raeesi63@nm.mui.ac.ir</email>
        <affiliation>Esfahan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Masoumeh Raeesi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 22, No. 4 Alley, Kaveh Ave, Aboureyhan St, Isfahan</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8193761925</zip>
        <telephone>+98 913 227 1978</telephone>
        <email>raeesi63@nm.mui.ac.ir</email>
        <affiliation>Esfahan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Family caregivers of people with ischemic stroke
One month has passed since the time of providing care</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Caregiver's age shouldn't be below  18 years and above 60 years
Not to participate in another similar study at the same time
Take care of two patients at the same time</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>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: For the people who entered the intervention group, first a face-to-face meeting will be held at the hospital, where the method of solving the problem will be explained based on the Koop model. In the creativity component, care problems are taught from different perspectives to develop new strategies to solve them. (For example, "I will be creative in my patient's daily activities.") In optimism, families should have a positive but realistic attitude toward the problem-solving process. As much as possible in planning, they convey realistic optimism to the patient (eg, "I believe that daily activities can be done.") In planning, reasonable care goals are set and steps are taken. What is necessary to achieve those goals is determined in advance (for example, "I plan my patient's daily activities so that he can also be present in the crowd."). In professional information, families are taught what nonprofessionals need to know about the nature of the problem, when to seek professional help, and what family caregivers can do on their own to cope (eg, I use available resources). I will use). Then a booklet about common problems and necessary training is given to the caregiver and he is asked to choose a problem and teach how to use the model and booklet to solve the problem. In this meeting, educational needs assessment is done by the individual and the family. The educational content and goals in the first session include: greetings, expressing goals and needs assessment, familiarizing the person with the disease, signs and symptoms, and at the end of the first session, an agreement is made about a phone call with him. Based on the patient's condition, face-to-face sessions will be between one and two hours, and phone sessions will last between 15 and 20 minutes.Three days after the first session, the researcher made a reminder phone call to the caregiver and read the booklet and asked questions about the implementation of the care according to the training program and agreed on a face-to-face meeting with the caregiver at the hospital to review the results of the previous session/fix the problems. be madeIn the second face-to-face meeting on the 16th day, the process is reviewed again and the caregiver is discussed about another problem and the use of models and booklets, and the time of the next phone call with him to teach new educational concepts is determined.In the next phone call, which will be made two days later, the carer's questions will be answered and he will be encouraged to use the model, and the time to complete the questionnaire will be agreed with him one month after the start of the program.The control group only receives hospital training at the time of discharge and follow-ups from the relevant hospital's health education unit, and after one month, the questionnaire is completed for them.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Care burden score. Timepoint: Measurement of care burden score before and immediately and one month after the intervention. Method of measurement: Zarit Caregiver Burden Scale.</prim_outcome>
      <prim_outcome>The overall quality of life score before and immediately and one month after the intervention. Timepoint: Measuring the overall quality of life score before and immediately and one month after the intervention. Method of measurement: World Health Organization 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>Esfahan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-12-26</approval_date>
        <contact_name>Ethics Committees of Nursing, Rehabilitation and Management schools- Isfahan University of m</contact_name>
        <contact_address>Faculty of Nursing and Midwifery, Isfahan University of Medical Sciences and Health Services, Hazar Jarib St Isfahan Isfehan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
