<?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>IRCT20220903055859N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-09-24</date_registration>
      <primary_sponsor>Hamedan University of Medical Sciences</primary_sponsor>
      <public_title>Development of  self-care supportive Programe for family caregivers and stroke patients and its effects on quality of life and resilience</public_title>
      <acronym></acronym>
      <scientific_title>Development of  self-care supportive Programe for family caregivers and stroke patients and its effects on quality of life and resilience; A Mixed-method study</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-10-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>80</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/65722</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Before randomly assigning to two intervention and control groups, questionnaires of demographic characteristics and Barthel scale for the patient to enter the study (in case of scoring between 40-55 and moderate dependency because they must have the ability to speak and cooperate to complete the questionnaires) will be. Based on the score obtained using Barthel's index, they will be placed in two test groups (40 pairs of caregivers and patients) and control (40 pairs of caregivers and patients).Blocked randomization is for the purpose of making sure that exactly equal number of participants are included in the intervention and control groups at consecutive but equal time intervals.</study_design>
      <phase>N/A</phase>
      <hc_freetext>CVA.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Intervention group: The self-care support program designed for patients and family caregivers will be implemented in four stages:  Assessment of self-care needs in the studied units and planning based on nursing diagnoses: in this stage, needs assessment based on the survey form and capacity recognition. Self-care of stroke patients and family caregivers will be done based on the needs assessment of the adjusted self-care program of the Orem model (needs related to growth and development, general needs, usual health patterns, and needs of deviation from health). In the self-care ability section, the questions will be in the three dimensions of awareness, motivation and skill. The awareness dimension includes 11 and the motivation includes 6 questions that will be measured with "yes and no", the skill dimension includes 16 questions that will be measured with "never, rarely, sometimes, most of the time and always", completed questionnaires will be analyzed by the clients in the test group and the existing problems will be addressed based on priority and it will be determined which public needs have been met and which needs have not yet been met, what factor caused these needs not to be met and the researcher What should he do to meet these needs? For example, nursing diagnoses can include the following: 1. Lack of self-care in the field of nutrition 2. Lack of self-care in the field of mobility and activity 3. Lack of self-care in the field of basic medication use 4. Lack of self-care in the field of mental and psychological support 5. Lack of self-care in the context of social behavior. Self-care program design in the form of training sessions: in this stage, the type of training and selection and the type of nursing system depending on the deficiencies of care information that will be listed in the first stage, and the clients are selected in two educational-supportive nursing systems.  Implementation of self-care support program: holding 2 training sessions depending on the patient's condition after discharge and when visiting the clinic or home and based on the needs of patients and family caregivers, each session will be 0.5 hours. was, placing educational pamphlets at the clients' disposal, establishing telephone and face-to-face communication with clients and caregivers on specific days of the week and strengthening their morale, using self-care checklists that will be designed to be completed in the second month of hospitalization.  Evaluation : Based on the goals in the field of reducing needs and increasing abilities in performing self-care activities and by measuring self-care ability, their self-report checklists will be collected. Intervention 2: Control group: The control  group is also used according to the care plan that will be taught at the time of discharge and is the routine of the neurology department. The questionnaires of the control group will also be completed within 2 months after visiting the specialized clinic in coordination with the neurologist and family caregivers. For the people of the test group, the number and duration of self-care support program sessions will be determined based on the number of goals and wishes of family caregivers and patients during coordination (by phone or in a specialized clinic). 2 face-to-face meetings at home or at a specialized clinic will be held individually and face-to-face to examine family caregivers and patients and prioritize goals and plan self-care support for each family caregiver and patient. Then the follow-up will be done in 4 consecutive weeks, by phone or through social networks. Family caregivers will be taught how to use the authorized social network program during the face-to-face meeting. Then, 2 months after the intervention, through telephone coordination with the patient who goes to their specialist doctor's office or neurology clinic for a return visit or is under care at home, face-to-face and self-declaration of family caregivers' resilience questionnaires and The quality of life of family caregivers and their patients will be improved.</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 Because the study is three-stage and general results should be obtained.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>seyyed reza Bourzo</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahid Fahmideh St, University of Medical Sciences ,Hamadan</address>
        <city>Hamadan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6517838736</zip>
        <telephone>+98 81 3131 0000</telephone>
        <email>borzoureza@gmail.com</email>
        <affiliation>Hamedan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Ahmad Nooreddini Avaz Mohammad</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahid Fahmideh St, University of Medical Sciences ,Hamadan</address>
        <city>Hamadan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6517838736</zip>
        <telephone>+98 81 3131 0000</telephone>
        <email>ahmad.nooredini@yahoo.com</email>
        <affiliation>Hamedan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Family caregivers: Having at least primary education Age above 18 years
Having a family relationship with the patient (daughter, son, sister, brother, father, mother and wife)
The main caregiver of the patient in the family at least 4 days a week for at least 2 months
Lack of history of specific psychological illness according to self-report
Patients : Having suffered a stroke for the first time
The average degree of dependence based on Barthel's criteria (the patient has the ability to speak).
The patient is hospitalized in the neurology department.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>G46</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Vascular syndromes of brain in cerebrovascular diseases</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Lifestyle</i_code>
      <i_code>Lifestyle</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Intervention group: The self-care support program designed for patients and family caregivers will be implemented in four stages:  Assessment of self-care needs in the studied units and planning based on nursing diagnoses: in this stage, needs assessment based on the survey form and capacity recognition. Self-care of stroke patients and family caregivers will be done based on the needs assessment of the adjusted self-care program of the Orem model (needs related to growth and development, general needs, usual health patterns, and needs of deviation from health). In the self-care ability section, the questions will be in the three dimensions of awareness, motivation and skill. The awareness dimension includes 11 and the motivation includes 6 questions that will be measured with "yes and no", the skill dimension includes 16 questions that will be measured with "never, rarely, sometimes, most of the time and always", completed questionnaires will be analyzed by the clients in the test group and the existing problems will be addressed based on priority and it will be determined which public needs have been met and which needs have not yet been met, what factor caused these needs not to be met and the researcher What should he do to meet these needs? For example, nursing diagnoses can include the following: 1. Lack of self-care in the field of nutrition 2. Lack of self-care in the field of mobility and activity 3. Lack of self-care in the field of basic medication use 4. Lack of self-care in the field of mental and psychological support 5. Lack of self-care in the context of social behavior. Self-care program design in the form of training sessions: in this stage, the type of training and selection and the type of nursing system depending on the deficiencies of care information that will be listed in the first stage, and the clients are selected in two educational-supportive nursing systems.  Implementation of self-care support program: holding 2 training sessions depending on the patient's condition after discharge and when visiting the clinic or home and based on the needs of patients and family caregivers, each session will be 0.5 hours. was, placing educational pamphlets at the clients' disposal, establishing telephone and face-to-face communication with clients and caregivers on specific days of the week and strengthening their morale, using self-care checklists that will be designed to be completed in the second month of hospitalization.  Evaluation : Based on the goals in the field of reducing needs and increasing abilities in performing self-care activities and by measuring self-care ability, their self-report checklists will be collected.</i_keyword>
      <i_keyword>Control group: The control  group is also used according to the care plan that will be taught at the time of discharge and is the routine of the neurology department. The questionnaires of the control group will also be completed within 2 months after visiting the specialized clinic in coordination with the neurologist and family caregivers. For the people of the test group, the number and duration of self-care support program sessions will be determined based on the number of goals and wishes of family caregivers and patients during coordination (by phone or in a specialized clinic). 2 face-to-face meetings at home or at a specialized clinic will be held individually and face-to-face to examine family caregivers and patients and prioritize goals and plan self-care support for each family caregiver and patient. Then the follow-up will be done in 4 consecutive weeks, by phone or through social networks. Family caregivers will be taught how to use the authorized social network program during the face-to-face meeting. Then, 2 months after the intervention, through telephone coordination with the patient who goes to their specialist doctor's office or neurology clinic for a return visit or is under care at home, face-to-face and self-declaration of family caregivers' resilience questionnaires and The quality of life of family caregivers and their patients will be improved.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Quality of life of patients, quality of life of family caregivers, resilience of family caregivers. Timepoint: Upon entering the study, two months later, four months later. Method of measurement: Standard questionnaires.</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>Hamedan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-08-23</approval_date>
        <contact_name>Ethics Committee of Hamadan University of Medical Sciences</contact_name>
        <contact_address>Hamedan University of Medical Sciences, Shahid Fahmida Street Hamadan Hamadan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
