<?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>IRCT20220724055540N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-08-11</date_registration>
      <primary_sponsor>Mashhad University of Medical Sciences</primary_sponsor>
      <public_title>The effect of peer support group on the care burden and unmet needs</public_title>
      <acronym></acronym>
      <scientific_title>The effect of peer support group on the care burden and unmet needs of caregivers of hemodialysis patients</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-08-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/64970</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Other design features: The number of sessions will be 8 sessions for the intervention group, two sessions for one hour each week in groups of 5 people. The subject of the peer support group meetings is based on the needs and interests of caregivers, which will be asked in the first meeting. Caregivers' needs that are raised more frequently and in more groups during the needs assessment session will be given higher priority to be raised in the support sessions and will be planned separately for the next seven sessions. At this stage, support meetings are held based on the importance of using group dynamics during the meetings and not one person riding on the time of the meeting, based on argumentative debate and nominal group techniques, so that every problem that is raised during the support meetings is discussed by all members. The group is placed and all the members have the right to comment and participate in the discussion, and the nurse and peer caregivers are encouraged to express their experiences and comment on the problems, and the caregivers are also asked to think, examine and analyze each other's solutions and methods of adaptation. and try to improve the mentioned solutions and experiences by providing their additional comments. In each meeting, the problem is first prioritized and discussed and experiences are shared according to the needs assessment meeting, then the peers receive feedback from the previous support meetings, and the way the caregivers use the materials mentioned in the previous meetings is questioned, and if new problems arise, These problems are evaluated by the nurse and peer and suggested solutions are provided to them by other caregivers. The community health nurse is present during the meetings and examines and analyzes the experiences and proposed solutions in order to modify and adjust unreasonable methods or dangerous, superstitious, unattainable and troublesome experiences in order to prevent the transmission of harmful experiences and causing losses. and avoid secondary risks, Randomization description: This semi-experimental study will be conducted on 60 caregivers of hemodialysis patients, first of all, two hemodialysis centers will be randomly selected from among public and private hemodialysis centers in which this plan can be implemented according to the required sample size. And then we consider one of these hemodialysis centers by lottery as the intervention center and the other as the center from which the control group is selected, 30 people in each group are randomly selected according to the entry criteria from among the private hemodialysis centers. and government in the city of Mashhad, after drawing lots, two centers in Hefdeh Shahrivar and Muntasarih were selected for sampling. They are homogenous and after that, Hefdeh Shahrivar Dialysis Center was considered as the intervention center and Mantasariyeh as the control center by drawing a ball from the bag, Blinding description: Data analysts who are responsible for entering sampling data and performing statistical tests are blinded to the data they are analyzing.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Kidney failure and hemodialysis.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: The number of sessions will be 8 sessions for the intervention group, two sessions for one hour each week in groups of 5 people. The subject of the peer support group meetings is based on the needs and interests of caregivers, which will be asked in the first meeting. Caregivers' needs that are raised more frequently and in more groups during the needs assessment session will be given higher priority to be raised in the support sessions and will be planned separately for the next seven sessions. At this stage, support meetings are held based on the importance of using group dynamics during the meetings and not one person riding on the time of the meeting, based on argumentative debate and nominal group techniques, so that every problem that is raised during the support meetings is discussed by all members. The group is placed and all the members have the right to comment and participate in the discussion, and the nurse and peer caregivers are encouraged to express their experiences and comment on the problems, and the caregivers are also asked to think, examine and analyze each other's solutions and methods of adaptation. and try to improve the mentioned solutions and experiences by providing their additional comments. In each meeting, the problem is first prioritized and discussed and experiences are shared according to the needs assessment meeting, then the peers receive feedback from the previous support meetings, and the way the caregivers use the materials mentioned in the previous meetings is questioned, and if new problems arise, These problems are evaluated by the nurse and peer and suggested solutions are provided to them by other caregivers. The community health nurse is present during the meetings and examines and analyzes the experiences and proposed solutions in order to modify and adjust unreasonable methods or dangerous, superstitious, unattainable and troublesome experiences in order to prevent the transmission of harmful experiences and causing losses. and prevent secondary risks, also the nurse records the support sessions so that after the session she can extract the topics of the session and make them available to the participants. Also, the nurse helps the peer in setting up the meeting on time, the order of the meeting, and observing the health protocols for the prevention of covid during the meeting, which peer support includes three dimensions:1- Emotional support: During the course of a person's life, self-confidence is faced with threats that increase doubts about their abilities, social attractiveness, or job performance, having someone to discuss personal problems with is a powerful resource between A person is responsible for dealing with threats to self-confidence, and this task is called emotional support and includes: means of care, encouragement, listening carefully, responding, reassurance, and avoiding advice and criticism.2- Informational support: If a person's problem is not easily solved, he looks for new information to solve it. This support is provided through recommendation mechanisms, suggestions, real words, problem-solving knowledge, and requires access to resources, independent assessment of etiology, intermittent course of action, and guidance on efficacy.3- Evaluation support: It requires the exchange of information related to self-evaluation and includes expressions that emphasize the appropriateness of feelings, cognition and behaviors. Its mechanism includes motivational aspects such as encouraging to persist in solving the problem, assuring the results of the efforts, helping to tolerate disappointment and optimism in the relationship, and these interactions create future positive expectations (22).In fact, the peer support system is a system of giving and receiving help based on key rules, including respect, responsibility sharing, and mutual empathy on a topic that is useful. The purpose of providing emotional support, information and assessment of the situation by those who were in the same situation before and experienced it. In this study, we use all three types of support, so that every person who needs help in any area will be supported and will be re-evaluated by peers to investigate new problems. In this study, we hold peer support group meetings, and after the meeting, the contents of each meeting will be available to the intervention group through pamphlets and from the platform of virtual space, and they can review the contents of the support meetings, the list of needs and problems. And the interests of the caregivers prepared in the first meeting are updated during the following meetings so that new needs are identified and the programs are updated and modified. In the peer support group, the nurse as a facilitator creates group effectiveness and the main role in holding meetings will be the responsibility of the peers, and the role of the nurse is mostly to correct the informational blind spots of the peers, provide supplementary and needed information to the peers, and increase the peer's ability to establish proper communication. With other caregivers, creating and producing appropriate content in the form of pamphlets and the content of support sessions, paying attention to the guidelines and health protocols regarding the covid disease during the sessions. Intervention 2: Control group: For the participants in Muntasarih hospital, who are the control group of the study, nursing training will be conducted according to the approvals of the patient education committee, and none of the participants in the study will be deprived of routine 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>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 Sampling has not been done yet</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Masoud Zare</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>dotors four  way</address>
        <city>mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>111111111</zip>
        <telephone>+98 51 3333 3333</telephone>
        <email>naderghenaati@gmail.com</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Masoud Zare</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>doctors four way</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>11111111</zip>
        <telephone>+98 51 1111 1111</telephone>
        <email>zaremd@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>The criteria for entering the research of caregivers: 1- Willingness to participate in the study and informed consent 2- Being the main caregiver of the patient 3- History of at least 6 months of regular dialysis of the patient 4- Reading and writing literacy 5- Absence of speech and hearing problems 6- Ability to make phone calls 7- Absence of mental problems Specific knowledge 8- Not being a part of the health team 9- Lack of support from the support group Peer entry criteria: 1- Acceptable and acceptable among other group members 2- Having interest and motivation to play a role 3- Ability to speak and conduct meetings with eloquent expression 4- Being a volunteer to teach others 5- Not having a history of mental and cognitive disorders 6- Having higher health literacy 7- More compatibility with care problems 8- Having proper communication skills</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Having a history of mental and cognitive disorders
Support by another support group
Being part of the health team
Having speech and hearing problems</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>N18.5</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Chronic kidney disease, stage 5</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: The number of sessions will be 8 sessions for the intervention group, two sessions for one hour each week in groups of 5 people. The subject of the peer support group meetings is based on the needs and interests of caregivers, which will be asked in the first meeting. Caregivers' needs that are raised more frequently and in more groups during the needs assessment session will be given higher priority to be raised in the support sessions and will be planned separately for the next seven sessions. At this stage, support meetings are held based on the importance of using group dynamics during the meetings and not one person riding on the time of the meeting, based on argumentative debate and nominal group techniques, so that every problem that is raised during the support meetings is discussed by all members. The group is placed and all the members have the right to comment and participate in the discussion, and the nurse and peer caregivers are encouraged to express their experiences and comment on the problems, and the caregivers are also asked to think, examine and analyze each other's solutions and methods of adaptation. and try to improve the mentioned solutions and experiences by providing their additional comments. In each meeting, the problem is first prioritized and discussed and experiences are shared according to the needs assessment meeting, then the peers receive feedback from the previous support meetings, and the way the caregivers use the materials mentioned in the previous meetings is questioned, and if new problems arise, These problems are evaluated by the nurse and peer and suggested solutions are provided to them by other caregivers. The community health nurse is present during the meetings and examines and analyzes the experiences and proposed solutions in order to modify and adjust unreasonable methods or dangerous, superstitious, unattainable and troublesome experiences in order to prevent the transmission of harmful experiences and causing losses. and prevent secondary risks, also the nurse records the support sessions so that after the session she can extract the topics of the session and make them available to the participants. Also, the nurse helps the peer in setting up the meeting on time, the order of the meeting, and observing the health protocols for the prevention of covid during the meeting, which peer support includes three dimensions:1- Emotional support: During the course of a person's life, self-confidence is faced with threats that increase doubts about their abilities, social attractiveness, or job performance, having someone to discuss personal problems with is a powerful resource between A person is responsible for dealing with threats to self-confidence, and this task is called emotional support and includes: means of care, encouragement, listening carefully, responding, reassurance, and avoiding advice and criticism.2- Informational support: If a person's problem is not easily solved, he looks for new information to solve it. This support is provided through recommendation mechanisms, suggestions, real words, problem-solving knowledge, and requires access to resources, independent assessment of etiology, intermittent course of action, and guidance on efficacy.3- Evaluation support: It requires the exchange of information related to self-evaluation and includes expressions that emphasize the appropriateness of feelings, cognition and behaviors. Its mechanism includes motivational aspects such as encouraging to persist in solving the problem, assuring the results of the efforts, helping to tolerate disappointment and optimism in the relationship, and these interactions create future positive expectations (22).In fact, the peer support system is a system of giving and receiving help based on key rules, including respect, responsibility sharing, and mutual empathy on a topic that is useful. The purpose of providing emotional support, information and assessment of the situation by those who were in the same situation before and experienced it. In this study, we use all three types of support, so that every person who needs help in any area will be supported and will be re-evaluated by peers to investigate new problems. In this study, we hold peer support group meetings, and after the meeting, the contents of each meeting will be available to the intervention group through pamphlets and from the platform of virtual space, and they can review the contents of the support meetings, the list of needs and problems. And the interests of the caregivers prepared in the first meeting are updated during the following meetings so that new needs are identified and the programs are updated and modified. In the peer support group, the nurse as a facilitator creates group effectiveness and the main role in holding meetings will be the responsibility of the peers, and the role of the nurse is mostly to correct the informational blind spots of the peers, provide supplementary and needed information to the peers, and increase the peer's ability to establish proper communication. With other caregivers, creating and producing appropriate content in the form of pamphlets and the content of support sessions, paying attention to the guidelines and health protocols regarding the covid disease during the sessions.</i_keyword>
      <i_keyword>Control group: For the participants in Muntasarih hospital, who are the control group of the study, nursing training will be conducted according to the approvals of the patient education committee, and none of the participants in the study will be deprived of routine care.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Care burden. Timepoint: Before the intervention and one month after the intervention. Method of measurement: Zarit Care Burden Questionnaire.</prim_outcome>
      <prim_outcome>Unmet needs. Timepoint: Before the intervention and one month after the intervention. Method of measurement: Questionnaire of support care needs of caregivers (SCNS-P&amp;C45).</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 ,Research assistant</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-11-30</approval_date>
        <contact_name>Ethics Committee of Faculty of Nursing and Midwifery , Mashhad University of Medical Sciences</contact_name>
        <contact_address>College of Nursing and Midwifery, Chaharrah Doktra, Ibn Sina Street, University of Mashhad, Razavi Khorasan Mashhad Razavi Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
