<?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>IRCT20181122041720N4</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2025-03-27</date_registration>
      <primary_sponsor>Islamic Azad University</primary_sponsor>
      <public_title>The impact of the Coop care model on family caregivers of elderly diabetics</public_title>
      <acronym></acronym>
      <scientific_title>The effect of an intervention program based on the family-centered model on the level of health literacy, understanding of the disease and the quality of life of family caregivers of the elderly with type 2 diabetes</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2025-04-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>90</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/82557</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Ninty caregivers of patients with type 2 diabetes 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 are not introduced to each other at all before, during, and after the intervention, and they do not meet each other until the end of the study, so they do not know which group the caregiver is in. Rather, the project administrator is only informed of which caregivers are in which group until the end of the study. Only people in the intervention group will be given the necessary supplementary materials and the necessary arrangements for holding the meetings in the WhatsApp groups, while these materials and arrangements will not be informed to the control group.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Type 2 diabetes.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Caregivers in the intervention group will participate in 6 training sessions designed based on the COOP model (reference). These sessions will be conducted by the researcher in nine groups of five people, with two sessions in the health centers of Shahrekord for 60 minutes and four sessions in the form of telephone calls for 30 minutes, along with follow-ups through WhatsApp groups over a period of one month. The scheduling of these sessions will be done in agreement with the researcher and the caregivers. In these sessions, the three main problems of each caregiver in relation to patient care, such as the patient's activity level, strategies for improving resilience, and other issues, will be examined based on the COOP model. In-person sessions, lecture techniques, question and answer, educational images, and educational booklets will be used according to the needs of the patients' caregivers. Intervention 2: Control group: Control group: In the control group, caregivers were provided with the necessary care and training, and no intervention was performed.</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>Shirin Madadkar Dehkordi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahrekord - Rahmatieh - Islamic Azad University</address>
        <city>Shahrekord</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8813733395</zip>
        <telephone>+98 38 3336 1001</telephone>
        <email>shirinmadadkar@gmail.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Shirin Madadkar Dehkordi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahrekord - Rahmatieh - Islamic Azad University</address>
        <city>Shahrekord</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8813733395</zip>
        <telephone>+98 38 3336 1001</telephone>
        <email>shirinmadadkar@gmail.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Willing to participate in research.
Be careful not to be a member of the health team
Must be able to read and write in Persian.
Do not simultaneously care for someone with another chronic illness.
A person is designated by the patient as the primary caregiver.
The patient under elderly care has type 2 diabetes.
The caregiver must be over 18 years of age and under 65 years of age.
Self-declares that he/she does not have a known psychiatric disorder</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Participate in a similar training program</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>E11</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Non-insulin-dependent diabetes mellitus</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: Caregivers in the intervention group will participate in 6 training sessions designed based on the COOP model (reference). These sessions will be conducted by the researcher in nine groups of five people, with two sessions in the health centers of Shahrekord for 60 minutes and four sessions in the form of telephone calls for 30 minutes, along with follow-ups through WhatsApp groups over a period of one month. The scheduling of these sessions will be done in agreement with the researcher and the caregivers. In these sessions, the three main problems of each caregiver in relation to patient care, such as the patient's activity level, strategies for improving resilience, and other issues, will be examined based on the COOP model. In-person sessions, lecture techniques, question and answer, educational images, and educational booklets will be used according to the needs of the patients' caregivers.</i_keyword>
      <i_keyword>Control group: Control group: In the control group, caregivers were provided with the necessary care and training, and no intervention was performed.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Resilience. Timepoint: Before the intervention, after the intervention and three months after the intervention. Method of measurement: Connor and Davidson Resilience Questionnaire (CD-RISC).</prim_outcome>
      <prim_outcome>Health literacy. Timepoint: Before the intervention, after the intervention and three months after the intervention. Method of measurement: TOFLA Health Literacy Questionnaire (TOFHLA).</prim_outcome>
      <prim_outcome>Illness Perception (IPQ-R). Timepoint: Before the intervention, after the intervention and three months after the intervention. Method of measurement: Illness Perception Questionnaire (IPQ-R).</prim_outcome>
      <prim_outcome>Minnesota Quality of Life. Timepoint: Before the intervention, after the intervention and three months after the intervention. Method of measurement: Minnesota Quality of Life 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>Islamic Azad University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2025-03-17</approval_date>
        <contact_name>Islamic Azad University, Shahrekord Branch</contact_name>
        <contact_address>Islamic Azad University, Shahrekord Branch Shahrekord Chahar-Mahal-va-Bakhtiari Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
