<?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>IRCT20260215068868N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2026-02-16</date_registration>
      <primary_sponsor>Jeeroft University of Medical Sciences</primary_sponsor>
      <public_title>Evaluating the Effectiveness of a Problem-Solving Skills Educational Intervention on Caregiver Burden and Resilience among Family Caregivers of Elderly Hemodialysis Patients Referred to Healthcare Centers</public_title>
      <acronym></acronym>
      <scientific_title>Evaluating the Effectiveness of a Problem-Solving Skills Educational Intervention on Caregiver Burden and Resilience among Family Caregivers of Elderly Hemodialysis Patients Referred to Healthcare Centers</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2026-02-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>68</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/89128</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Other, Purpose: Supportive, Randomization description: Participants are allocated to either the intervention or control group through simple randomization using the last two digits of their national ID numbers. Specifically, if the last two digits of the national ID number are even, the individual is assigned to the intervention group, and if they are odd, they are assigned to the control group.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Caregiver Burden and Resilience among Family Caregivers of Elderly Hemodialysis Patients.</hc_freetext>
      <i_freetext>Intervention 1: Intervention Group:In this group, 34 caregivers will be allocated through simple randomization (based on whether the last two digits of their national ID number are even or odd). Participants will attend five weekly problem-solving skills training sessions over five consecutive weeks (each session lasting approximately one hour). The sessions will be conducted by the nurse researcher and will include a combination of brief lectures with PowerPoint presentations, group discussions, and question-and-answer segments. At the end of the first session, an educational booklet will be provided to participants. Questionnaires will be completed at three time points: before the intervention, immediately after completion of the sessions, and one month after the end of the intervention. Intervention 2: Control group: Another 34 caregivers who are randomly assigned to the control group will receive no training or intervention during the study period and will only complete the questionnaires at the same three time points as the intervention group. To adhere to research ethics principles, after the completion of the study, the educational content will be delivered to this group in a two-hour session, and the educational booklet will also be provided to them.</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:
Based on the findings of the study, educational content tailored to the needs of family caregivers of older adults undergoing hemodialysis will be developed. This content will be designed in the form of simple, easy-to-understand educational brochures using non-technical language and practical instructional images.

In addition, a short educational video focusing on problem-solving skills training and strategies to enhance caregivers’ resilience will be produced. This video can be presented in dialysis centers, health education programs, and health-related social media platforms. In developing these materials, the scientific findings of the study and the real needs of caregivers will be utilized to ensure that the content is practical, effective, and understandable for the general public.

When:
After completion of the study

To whom:
Submission of the research findings to Shiraz University of Medical Sciences 
Presentation of the findings at meetings of Clinical Ethics Committees and Quality Improvement Committees in healthcare centers
Publication of the article in reputable national or international scientific journals
Sharing the findings with associations related to older adults, caregivers, and patients with kidney disease

Conditions:
Follow-up and evaluation of learning through questionnaires and home-based exercises

Designing simple and practical tools (such as brochures and problem-solving checklists) for caregivers to use in the home setting

Where to obtain:
Submission of the research findings to Shiraz University of Medical Sciences 
Presentation of the findings at meetings of Clinical Ethics Committees and Quality Improvement Committees in healthcare centers
Publication of the article in reputable national or international scientific journals
Sharing the findings with associations related to older adults, caregivers, and patients with kidney disease

How to obtain:
Submission of the research findings to Shiraz University of Medical Sciences 
Presentation of the findings at meetings of Clinical Ethics Committees and Quality Improvement Committees in healthcare centers
Publication of the article in reputable national or international scientific journals
Sharing the findings with associations related to older adults, caregivers, and patients with kidney disease

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Shaghayegh Yadollahi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Unit 23, Block A, Pasargad Building, Molana 5 Street, Molana Boulevard, Sadra, Shiraz, Iran</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7199885943</zip>
        <telephone>009871336436892</telephone>
        <email>shaghayeghyadollahi547@gmail.com</email>
        <affiliation>Jeeroft University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr Motahare Faramarzpoor</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Jiroft University of Medical Sciences, Shahed Square, Bargh Township, Jiroft</address>
        <city>Jiroft</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7861756447</zip>
        <telephone>+98 34 4331 9085</telephone>
        <email>mfaramarzpor61@gmail.com</email>
        <affiliation>Jeeroft University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria for caregivers:
having no diagnosed psychiatric disorders
Willingness to participate in the study.
Ability to read and write.
Age between 18 and 65 years
No participation in similar educational programs during the past six months
Inclusion criteria for older adults:
Age 65 years or older
No severe cognitive impairment or dementia
Having no more than two diagnosed chronic diseases.
No history of kidney transplantation
Having a primary family caregiver for home care</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Patient death
Caregiver absence from two educational sessions
Diagnosis of a new illness in the patient
Caregiver’s unwillingness to continue participation during the study
Occurrence of a family crisis (such as divorce, financial crisis, or death of a first-degree family member) during the study period</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>N19</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Unspecified kidney failure</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:In this group, 34 caregivers will be allocated through simple randomization (based on whether the last two digits of their national ID number are even or odd). Participants will attend five weekly problem-solving skills training sessions over five consecutive weeks (each session lasting approximately one hour). The sessions will be conducted by the nurse researcher and will include a combination of brief lectures with PowerPoint presentations, group discussions, and question-and-answer segments. At the end of the first session, an educational booklet will be provided to participants. Questionnaires will be completed at three time points: before the intervention, immediately after completion of the sessions, and one month after the end of the intervention.</i_keyword>
      <i_keyword>Control group: Another 34 caregivers who are randomly assigned to the control group will receive no training or intervention during the study period and will only complete the questionnaires at the same three time points as the intervention group. To adhere to research ethics principles, after the completion of the study, the educational content will be delivered to this group in a two-hour session, and the educational booklet will also be provided to them.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Resilience. Timepoint: Data will be analyzed using descriptive statistics, independent t-test, paired t-test, and, if necessary, non-parametric tests. Method of measurement: The Connor- Davidson Resilience Scale, and the Zarit Burden Interview.</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>Jeeroft University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2025-09-23</approval_date>
        <contact_name>Research Ethics Committee of Jiroft University of Medical Sciences</contact_name>
        <contact_address>Research and Technology Vice-Chancellery Building, Pasdaran Blvd, Jiroft, Iran Jiroft Kerman Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
