<?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>IRCT20211128053202N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-02-20</date_registration>
      <primary_sponsor>Esfahan University of Medical Sciences</primary_sponsor>
      <public_title>The effect of supportive-educational program based on Cope care model on resilience, care burden and quality of life</public_title>
      <acronym></acronym>
      <scientific_title>Evaluation of the effectiveness of supportive-educational program based on Cope care model on resilience, care burden and quality of life of family caregivers of patients with heart failure</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-01-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>90</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/61165</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Other, Purpose: Supportive, Randomization description: Ninty caregivers of patients with heart failure who were eligible for the study are randomly assigned (by card method) to the experimental and control groups, so that 45 cards with number one and 45 cards Number two will be placed in a package in an envelope. And on the day of random division of research units, caregivers will be asked to choose a card. People who belong to number one are in the test group. And the people assigned to number two will be in the control group, Blinding description: The people in the intervention and control groups do not get to know each other before, during and after the intervention and do not meet until the end of the study so that they do not know which group the caregiver is in.Rather, only by the end of the study do the facilitator and the student know which caregivers are in which group.
Only those in the intervention group in the WhatsApp groups will be given the necessary additional information and coordination to hold meetings, while these materials and coordination will not be notified to the control group.
 The booklet provided at the time of sampling to individuals in both intervention and control groups has the same content.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Cope model, Family caregivers of patients with heart failure.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Selection of three major common problems among caregivers during the care of a patient with heart failure, then during the sessions, all three problems of individuals based on the coupe model are addressed. In this way, the booklet (which is based on the common problems of caregivers) is given to them in the introductory session. 1. Based on the priority of problems in each session, the coupe model is used(Apply the problem-solving process based on the coup model to each problem(According to the components of the model, this model is implemented, which includes: In the creative component: Since it is an intellectual and motivational activity, in this regard, the caregiver is encouraged to be able to see different aspects of the problem and by using his abilities and characteristics, he can come up with new and appropriate ideas and solutions for the problems and gaps. Compile with difficulty.In the optimism component: take care to have a positive yet realistic attitude and flexibility in relation to the guided problem solving process, which, In addition to accepting himself and recognizing his value, he can be encouraged to control his thoughts and feelings and maintain a sense of competence and efficiency. Caregivers are also encouraged to establish an intimate and optimistic relationship with the patient and to gain trust and show their understanding and hope in this regard. In addition, he encourages the patient to take care of himself with empathy. In the planning component: in order to solve problems, the caregiver is guided to follow a regular and accurate approach to identify, solve problems, review and follow the specified program. In the specialized information component: the caregiver seeks to receive information from health professionals in order to understand different aspects of the disease, situations, problems and care needs for the patient, as well as to increase information, understand emotions and how to deal with it, as a caregiver. Follows)). Be sure to copy the caregivers before, during and after the sessions to encourage the use of the booklet in accordance with the problem under consideration in each session to complete the implementation of the model. Intervention 2: Control group: Coupe model booklet and informed consent questionnaire, demographic information form and questionnaires of other variables were given to them in the first meeting with caregivers (before the intervention for the experimental group) and after three months (three months after the intervention) will be completed by the caregivers.</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 this study has not been done yet and I will decide about it when it is done.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Sima Babaei</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Nursing and Midwifery; Isfahan University of Medical Sciences; Hezar Jerib Street</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>81746-73461</zip>
        <telephone>+98 31 3792 7543</telephone>
        <email>babaee@nm.mui.ac.ir</email>
        <affiliation>Esfahan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Sima Babaei</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Nursing and Midwifery; Isfahan University of Medical Sciences; Hezar Jerib Street</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>81746-73461</zip>
        <telephone>+98 31 3792 7543</telephone>
        <email>babaee@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>The age of the caregiver is over 18 years and less than 65 years.
Not participating in another similar study at the same time.
Not taking care of another person with a chronic disease at the same time.
The person declares that the psychiatric disorder is not known
The person should be appointed from the patient as the main caregiver
The person under his care must be a patient with heart failure and have already referred to the center for treatment.
Ability to use virtual networks.
Being able to read and write in Persian.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>The unwillingness of the person to participate in the study
Caregiver be a member of the health team.</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>Other</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Selection of three major common problems among caregivers during the care of a patient with heart failure, then during the sessions, all three problems of individuals based on the coupe model are addressed. In this way, the booklet (which is based on the common problems of caregivers) is given to them in the introductory session. 1. Based on the priority of problems in each session, the coupe model is used(Apply the problem-solving process based on the coup model to each problem(According to the components of the model, this model is implemented, which includes: In the creative component: Since it is an intellectual and motivational activity, in this regard, the caregiver is encouraged to be able to see different aspects of the problem and by using his abilities and characteristics, he can come up with new and appropriate ideas and solutions for the problems and gaps. Compile with difficulty.In the optimism component: take care to have a positive yet realistic attitude and flexibility in relation to the guided problem solving process, which, In addition to accepting himself and recognizing his value, he can be encouraged to control his thoughts and feelings and maintain a sense of competence and efficiency. Caregivers are also encouraged to establish an intimate and optimistic relationship with the patient and to gain trust and show their understanding and hope in this regard. In addition, he encourages the patient to take care of himself with empathy. In the planning component: in order to solve problems, the caregiver is guided to follow a regular and accurate approach to identify, solve problems, review and follow the specified program. In the specialized information component: the caregiver seeks to receive information from health professionals in order to understand different aspects of the disease, situations, problems and care needs for the patient, as well as to increase information, understand emotions and how to deal with it, as a caregiver. Follows)). Be sure to copy the caregivers before, during and after the sessions to encourage the use of the booklet in accordance with the problem under consideration in each session to complete the implementation of the model.</i_keyword>
      <i_keyword>Control group: Coupe model booklet and informed consent questionnaire, demographic information form and questionnaires of other variables were given to them in the first meeting with caregivers (before the intervention for the experimental group) and after three months (three months after the intervention) will be completed by the caregivers.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Caregiver burden based on Zariat questionnaire. Timepoint: Before intervention, after intervention and three months after intervention. Method of measurement: Zariat questionnaire.</prim_outcome>
      <prim_outcome>Quality of life score based on SF-36 questionnaire. Timepoint: Before intervention, after intervention and three months after intervention. Method of measurement: Quality of Life Questionnaire SF-36.</prim_outcome>
      <prim_outcome>Caregiver resilience score based on Conner and Davidson questionnaire. Timepoint: Before intervention, after intervention and three months after intervention. Method of measurement: Conner and Davidson 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>2021-12-25</approval_date>
        <contact_name>Isfahan University of Medical Sciences</contact_name>
        <contact_address>School of Nursing and Midwifery; Isfahan University of Medical Sciences; Hezar Jerib Street Isfahan Isfehan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
