<?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>IRCT20221006056103N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-11-22</date_registration>
      <primary_sponsor>Bagheiat-allah University of Medical Sciences</primary_sponsor>
      <public_title>The effect of family health literacy in controlling delayed complications of covid-19</public_title>
      <acronym></acronym>
      <scientific_title>The Effectiveness Of Health Literacy Promotion Based On Family-Centered Empowerment Model On Common Delayed Outcomes Of Patients With Covid 19</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-10-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>70</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/66191</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: In this research, at the beginning, sampling will be done as available. The samples included in the study will be placed into two groups, test and control, through random allocation with classified blocks. The blocks used in this research are four blocks in It is considered that the houses of each block are marked with Latin letters A (test) and B (control group). All the possible possibilities regarding the arrangement of the blocks are determined and placed in the basket, and randomly the blocks are taken out and based on that, the samples are placed in two control and test groups. This process continues until we reach the desired sample size, Blinding description: In this research, the participants in the control and intervention groups receive both interventions and routine trainings, but the intervention group samples are also trained by the researcher in addition to receiving routine trainings, and each of the participants from They do not know whether they are in the intervention group or the control group.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Covid19.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: After people are placed in the control and test groups, a demographic questionnaire is given to the samples of the test group using random allocation, and then after the first-degree family member who was responsible for taking care of the patient, it is determined that Using a health literacy questionnaire, the level of family health literacy in the test group is examined, and in the next step, using questionnaires to measure the delayed complications of Covid-19 patients, which includes the assessment of the patients' fatigue and shortness of breath, the basic condition of the test group samples. After the discharge of the patients in the test group, the care package according to the latest standard recipes and approved by the experts in this field is given to the same person from the family who takes care of the patient in a group method based on A family-oriented model will be presented. In the first step, meetings (usually the first and second meeting) with the aim of the perceived threat through increasing the level of knowledge and understanding about the problems threatening the patient, as well as the nature, complications, process, prognosis and symptoms of the disease will be held face to face and in person. At the end of the session, educational cards containing a summary of the topics raised in the sessions will be given to the participants to review the material. In the second step of the session, to solve the problems and problems of the patients, training on functional matters such as how to perform effective breathing, planning activity and rest periods, methods Correctly performing the activities and movements by the method of problem solving and group discussion and transfer of experiences will be done in the form of virtual video call with the members, and the goal is to identify the issues and problems by the research units and provide solutions on their behalf and improve self-efficacy. In the third step, the participants teach the patient about the issues raised and participate as a health liaison in patient care, which increases self-confidence. In the last step, the evaluation will be done one week as a process evaluation and 6 weeks later as a brain evaluation by questionnaire. In total, 30-40 minutes of time will be considered for 3-5 sessions. After 1 week (process evaluation) and 6 weeks (brain evaluation), the level of shortness of breath and fatigue will be checked again. Intervention 2: Control group: The working method is that after selecting the samples of the participants in the study and after placing the people in the control groups using random allocation, a demographic questionnaire is given to the samples of both groups, and then Since the first degree family member who was responsible for the patient's care, it was determined that the level of family health literacy in the control group was investigated using the health literacy questionnaire, and in the next step, using questionnaires to measure the delayed complications of Covid-19 patients. It includes checking the level of fatigue and shortness of breath of the patients. The basic condition of the control group samples is checked. The control group is also trained with the routine training of the department. Braindy's evaluation) again, the degree of shortness of breath and fatigue will be examined.</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>Dr.Rababe Khalili</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Sheikh Bahai St</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1435916471</zip>
        <telephone>+98 21 8755 5250</telephone>
        <email>khalili1120@gmail.com</email>
        <affiliation>Bagheiat-allah University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Rababe Khalili</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Sheikh Bahai St</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1435916471</zip>
        <telephone>+98 21 8755 5250</telephone>
        <email>khalili1120@gmail.com</email>
        <affiliation>Bagheiat-allah University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Criteria for inclusion in the study are patients with COVID-19 who have been admitted to hospital wards and have been diagnosed with COVID-19 through a positive PCR and CT Scan report.
Patients should not have fever for 3 consecutive days at the time of discharge
Include level 2 and 3 patients of the classification of Covid 19 patients based on the instructions issued by the Ministry of Health
The patient's spo2 should be between 85 and 93 during discharge
Involvement of more than 50% in lung CT scan
During the clearance of inflammatory markers, the proportion of early stages has decreased
COVID 19 through positive PCR and CT Scan report..Patient caregiver inclusion criteria The patient's caregiver is the person with whom the patient lives and is responsible for taking care of the patient
The health literacy level of the patient's family member (participant) should be less than 66 based on the health literacy
Willingness to participate in the study
Having minimum literacy in reading and writing
The patient's caregiver should have the ability to learn and communicate effectively</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>History of underlying disease such as lung disease, cardiac disorders, and skeletal-muscular disorders</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>U07.1</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>COVID-19, virus identified</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: After people are placed in the control and test groups, a demographic questionnaire is given to the samples of the test group using random allocation, and then after the first-degree family member who was responsible for taking care of the patient, it is determined that Using a health literacy questionnaire, the level of family health literacy in the test group is examined, and in the next step, using questionnaires to measure the delayed complications of Covid-19 patients, which includes the assessment of the patients' fatigue and shortness of breath, the basic condition of the test group samples. After the discharge of the patients in the test group, the care package according to the latest standard recipes and approved by the experts in this field is given to the same person from the family who takes care of the patient in a group method based on A family-oriented model will be presented. In the first step, meetings (usually the first and second meeting) with the aim of the perceived threat through increasing the level of knowledge and understanding about the problems threatening the patient, as well as the nature, complications, process, prognosis and symptoms of the disease will be held face to face and in person. At the end of the session, educational cards containing a summary of the topics raised in the sessions will be given to the participants to review the material. In the second step of the session, to solve the problems and problems of the patients, training on functional matters such as how to perform effective breathing, planning activity and rest periods, methods Correctly performing the activities and movements by the method of problem solving and group discussion and transfer of experiences will be done in the form of virtual video call with the members, and the goal is to identify the issues and problems by the research units and provide solutions on their behalf and improve self-efficacy. In the third step, the participants teach the patient about the issues raised and participate as a health liaison in patient care, which increases self-confidence. In the last step, the evaluation will be done one week as a process evaluation and 6 weeks later as a brain evaluation by questionnaire. In total, 30-40 minutes of time will be considered for 3-5 sessions. After 1 week (process evaluation) and 6 weeks (brain evaluation), the level of shortness of breath and fatigue will be checked again.</i_keyword>
      <i_keyword>Control group: The working method is that after selecting the samples of the participants in the study and after placing the people in the control groups using random allocation, a demographic questionnaire is given to the samples of both groups, and then Since the first degree family member who was responsible for the patient's care, it was determined that the level of family health literacy in the control group was investigated using the health literacy questionnaire, and in the next step, using questionnaires to measure the delayed complications of Covid-19 patients. It includes checking the level of fatigue and shortness of breath of the patients. The basic condition of the control group samples is checked. The control group is also trained with the routine training of the department. Braindy's evaluation) again, the degree of shortness of breath and fatigue will be examined.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Tiredness. Timepoint: 7 and 42 days. Method of measurement: Fatigue Severity Scale Questionnaire.</prim_outcome>
      <prim_outcome>Shortness of breath. Timepoint: 7 and 42 days. Method of measurement: Borg scale.</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>Bagheiat-allah University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-08-14</approval_date>
        <contact_name>Ethics Committee of Baqiyatullah University of Medical Sciences</contact_name>
        <contact_address>Ba'ath Township, Fakhrizadeh Street,Nobonyad Square Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
