<?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>IRCT20231206060282N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2024-01-08</date_registration>
      <primary_sponsor>Mashhad University of Medical Sciences</primary_sponsor>
      <public_title>The effect of social network support on psychological well-being and caregiving Appraisal of family caregivers</public_title>
      <acronym></acronym>
      <scientific_title>The effect of supportive intervention based on social network on psychological well-being and caregiving Appraisal in family caregivers of patients with heart failure</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2024-01-10</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>72</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/74233</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Other design features: The content of online meetings in Messenger is held as follows: Session 1: introducing people to the group members, questions and answers about heart failure disease and the care needed for these patients and their role in care, asking the group members to be ready to present their experiences in care for the next session. Session 2: Inviting the group members to share their negative and positive experiences in providing patient care, their solutions in providing care and how to deal with the patient's condition. Session 3: emphasizing the importance of physical and mental health of caregivers, asking caregivers to express how they take care of themselves, then providing self-care strategies for caregivers by the researcher. Session 4: Expressing the impact of stress on the health of caregivers and family members, asking caregivers to express their strategies to deal with caregiving stress, then presenting strategies for managing stress, anger, and depression with deep breathing techniques, relaxation, and planning to do favorite activities by researcher. Session 5: Ways to interact and communicate with other family members and others, peers, maintaining humor in difficult situations. Session 6: Emphasis on positive thinking, skills of creating and maintaining positive thoughts in daily life events, asking caregivers to express their strategies for positive thinking in caregiving and daily life. Session 7: Questions and answers from the caregivers about their experiences of using the strategies presented in the previous sessions by the peers and the researcher. Session 8: Final summary of the intervention, if necessary, refer the caregivers to available support resources in the community, such as (psychiatrist, psychologist, social worker...), Randomization description: Random allocation will be done in such a way that people will be divided into two groups through the PASS 11 software using blocks of four. In this way, after determining the sequence, we put them in the envelopes and number them in order. Caregivers take the envelope in the order of their entry into the study and are placed in the intervention or control group.</study_design>
      <phase>3</phase>
      <hc_freetext>Heart failure.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: In the intervention group, First, a half-hour to one-hour face-to-face training session with the presence of the main family caregivers of the patients will be held in one of the rooms of the aforementioned departments that in this meeting, in addition to introducing and stating the goals, explanations about how to carry out the research and messenger and help the caregiver to install it and training how to communicate in online meetings will be provided. Then, after the patient's discharge, in 8 sessions for one month (2 times a week), the researcher will communicate with the caregivers in specific groups of 5-6 people through online messenger and audio or video calls whose content includes: The care needed by the patient and the caregiver's role in care, sharing their negative and positive experiences in providing patient care, the importance of the caregiver's physical and mental health and self-care strategies, stress and anger management, methods of interacting with others, maintaining a sense of humor, strategies Positive thinking in care and daily life events and if necessary referring caregivers to support resources available in society (psychiatrist, psychologist, social worker). The researcher will be present and actively cooperate in all face-to-face and non-face-to-face meetings of messaging groups and will use the advice of a psychologist. Intervention 2: Control group: The control group will receive only usual care.</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:
All the data obtained from this research will be shared after completion.

When:
Access to the data will be possible 3 months after the results are published.

To whom:
These data will be used for researchers working in academic and scientific institutions, as well as for family caregivers of heart failure patients.

Conditions:
The data obtained from this research can be used in other scientific studies.

Where to obtain:
Copying (in any way) either from the full text or from the extracts is possible only with the coordination of the supervisor and the registered author and according to the instructions provided by the Central Library of Mashhad University of Medical Sciences. Details can be accessed through the relevant faculty library. The use of the thesis in articles or any scientific writing is subject to citing the source in compliance with the Mashhad University of Medical Sciences publishing regulations. Zahra Dalir: DalirZ@mums.ac.ir, Marzieh Kohantorabi: Kohantorabim4001@mums.ac.ir

How to obtain:
The applicant should send an email to the responsible author and register his request. After verifying the correctness of the information of the mentioned person, the required content will be provided to him by mentioning the source.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Zahra Dalir</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Azadi Square, East Gate of Ferdowsi University of Mashhad, Medical Sciences Campus, Shahid Dr. Kharazmi Educational Complex</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>‎9177949025</zip>
        <telephone>+98 51 3884 6730</telephone>
        <email>DalirZ@mums.ac.ir</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Marzieh Kohantorabi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahid Dr. Kharazmi Educational Complex, East Gate of Ferdowsi University of Mashhad, Medical Sciences Campus, Azadi Square</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>‎9177949025</zip>
        <telephone>+98 51 3884 6730</telephone>
        <email>Kohantorabim4001@mums.ac.ir</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>A patient with heart failure class 2 or higher for at least 3 months ago
Hospitalization of the patient in the ward due to heart failure
Caregiver's willingness to participate in research
Caregiver age over 18 years
Being the main caregiver of the patient in family
A history of at least 3 months of caring for a heart failure patient
Caregiver access to a smart phone and the ability to use messengers
Ability to speak and understand Persian language
Ability to read and write
Not having a history of known mental disorders and psychoactive drugs</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Caregiver's unwillingness to continue cooperation in any of the stages of the research
Non-participation of the caregiver in half of the messenger sessions
Transferring the care of the patient to someone other than the main caregiver at home
Experiencing a stressful event or severe emotional problem during the follow-up period for the caregiver
Death of the patient</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>I50</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Heart failure</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Other</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: In the intervention group, First, a half-hour to one-hour face-to-face training session with the presence of the main family caregivers of the patients will be held in one of the rooms of the aforementioned departments that in this meeting, in addition to introducing and stating the goals, explanations about how to carry out the research and messenger and help the caregiver to install it and training how to communicate in online meetings will be provided. Then, after the patient's discharge, in 8 sessions for one month (2 times a week), the researcher will communicate with the caregivers in specific groups of 5-6 people through online messenger and audio or video calls whose content includes: The care needed by the patient and the caregiver's role in care, sharing their negative and positive experiences in providing patient care, the importance of the caregiver's physical and mental health and self-care strategies, stress and anger management, methods of interacting with others, maintaining a sense of humor, strategies Positive thinking in care and daily life events and if necessary referring caregivers to support resources available in society (psychiatrist, psychologist, social worker). The researcher will be present and actively cooperate in all face-to-face and non-face-to-face meetings of messaging groups and will use the advice of a psychologist.</i_keyword>
      <i_keyword>Control group: The control group will receive only usual care.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Psychological well-being. Timepoint: The level of psychological well-being in the research units participating in the study will be measured at the beginning of the study (before the start of the intervention) and one month after the start of the intervention. Method of measurement: In this research, the level of psychological well-being will be measured using Ryff's Psychological Well-being questionnaire.</prim_outcome>
      <prim_outcome>Caregiving appraisal. Timepoint: The level of caregiving appraisal in the research units participating in the study will be measured at the beginning of the study (before the start of the intervention) and one month after the start of the intervention. Method of measurement: In this research, caregiving appraisal will be measured using revised caregiving appraisal scale(2000).</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>Mashhad University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-11-28</approval_date>
        <contact_name>Ethics Committee of Nursing and Midwifery Faculty - Mashhad University of Medical Sciences</contact_name>
        <contact_address>Shahid Dr. Kharazmi Educational Complex, East Gate of Ferdowsi University of Mashhad, Medical Sciences Campus, Azadi Square, Mashhad Razavi Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
