<?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>IRCT20220131053901N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-05-06</date_registration>
      <primary_sponsor>Mashhad University of Medical Sciences</primary_sponsor>
      <public_title>Effect of family-centered reminiscence on elder abuse</public_title>
      <acronym></acronym>
      <scientific_title>Effect of family-centered reminiscence on elder abuse</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-06-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>68</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/61840</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: Participants in the study are assigned to the control and intervention groups after the inclusion criteria are established using the permutation block method. In this method, first the volume of each block is determined, then the list of blocks is written and numbers are assigned to them, and then random numbers are selected from them, and finally the list is specified.</study_design>
      <phase>N/A</phase>
      <hc_freetext>elderly abuse.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Initially, the assessment of Homes tic Elder Abuse Questionnaire for assessing elder abuse in the family will be asked by the researcher to the elderly themselves by telephone in two or three telephone calls (according to the elderly) and in the absence of the caregiver. Caregivers will also complete the Caregiver Abuse Screen online after receiving the link. Then, for the intervention group, a virtual group will be formed in one of the selected internal messengers of family caregivers or Whats-app. The main caregivers of the elderly will be in the intervention group and under the guidance and leadership of the researcher. In the education section, during the first two sessions, the researcher will teach the concepts of aging, elder abuse and how to communicate effectively with the elderly. The educational content is selected from reputable geriatric education resources, and with the guidance of professors specializing in this field, and is shared virtually in the group formed in cyberspace, and to ensure the study and understanding of topics by group members, questions and answers The active participation of group members is also considered. The primary caregiver is then asked to include at least one 5- to 7-minute audio file (with the consent of the elderly and family) each week for 6 weeks from a memory whose subject matter is determined each week according to a family-centered reminiscence program. Defines, send to the researcher to be shared by the researcher in the group if it does not conflict with the research rules. The topics of the family-centered reminiscence program each week include: life events, family history, family-related professional memories, experiences with stress or feelings of belonging, and meaningful and purposeful memories of life. The family caregiver will evaluate his or her memories (pleasant and unpleasant) with the support and guidance of the researcher. Intervention 2: Control group: For the elderly and caregivers of the control group, at the beginning of the study, the questionnaires will be completed according to the intervention group. During the study, routine measures of the health center will be performed for them. It should be noted that health centers do not provide any special services in the field of elder abuse, but routinely monitor and follow the health status of the elderly referred to the center or the elderly covered by them. Done. One week after the reminiscence sessions of the intervention group, the questionnaires will be completed online by the caregiver and by telephone by the researcher for the elderly and in the absence of the primary caregiver. If the elderly abuse score of the control group is high, they will be referred to a psychiatrist at the health center.</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 I will make a decision after the study</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Fatemeh Shahsavand</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Nursing and midwifery college of Mashhad University of Medical Science, Ebne-Sina Street, Dotora Intersection, Mashhad, Iran</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9137913199</zip>
        <telephone>+98 51 3859 1511</telephone>
        <email>shahsavandf992@mums.ac.ir</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Fatemeh Esmaeilzadeh Noghabi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Nursing and midwifery college of Mashhad University of Medical Science, Ebne-Sina Street, Dotora Intersection, Mashhad, Iran</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9137913199</zip>
        <telephone>+98 51 3859 1511</telephone>
        <email>Esmaeilzadehf@mums.ac.ir</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Conscious consent to participate in this research
Age over 60
Ability to speak Persian and no deafness
Score above seven on the cognitive shortened test (AMT)
Having a spouse or child who is in contact with the elderly at least once a week
2) Inclusion criteria for the family caregiver:
Conscious consent to participate in this study
Caring for the elderly for more than three months
Using social networks with a smartphone
Not receiving money to provide care</inclusion_criteria>
      <agemin>60 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Death of the elderly or main family caregiver
the reluctance of any elderly or family caregiver to continue working with the researcher</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>Yo7.2</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Other maltreatment By acquaintance or friend</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Initially, the assessment of Homes tic Elder Abuse Questionnaire for assessing elder abuse in the family will be asked by the researcher to the elderly themselves by telephone in two or three telephone calls (according to the elderly) and in the absence of the caregiver. Caregivers will also complete the Caregiver Abuse Screen online after receiving the link. Then, for the intervention group, a virtual group will be formed in one of the selected internal messengers of family caregivers or Whats-app. The main caregivers of the elderly will be in the intervention group and under the guidance and leadership of the researcher. In the education section, during the first two sessions, the researcher will teach the concepts of aging, elder abuse and how to communicate effectively with the elderly. The educational content is selected from reputable geriatric education resources, and with the guidance of professors specializing in this field, and is shared virtually in the group formed in cyberspace, and to ensure the study and understanding of topics by group members, questions and answers The active participation of group members is also considered. The primary caregiver is then asked to include at least one 5- to 7-minute audio file (with the consent of the elderly and family) each week for 6 weeks from a memory whose subject matter is determined each week according to a family-centered reminiscence program. Defines, send to the researcher to be shared by the researcher in the group if it does not conflict with the research rules. The topics of the family-centered reminiscence program each week include: life events, family history, family-related professional memories, experiences with stress or feelings of belonging, and meaningful and purposeful memories of life. The family caregiver will evaluate his or her memories (pleasant and unpleasant) with the support and guidance of the researcher.</i_keyword>
      <i_keyword>Control group: For the elderly and caregivers of the control group, at the beginning of the study, the questionnaires will be completed according to the intervention group. During the study, routine measures of the health center will be performed for them. It should be noted that health centers do not provide any special services in the field of elder abuse, but routinely monitor and follow the health status of the elderly referred to the center or the elderly covered by them. Done. One week after the reminiscence sessions of the intervention group, the questionnaires will be completed online by the caregiver and by telephone by the researcher for the elderly and in the absence of the primary caregiver. If the elderly abuse score of the control group is high, they will be referred to a psychiatrist at the health center.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Elderly abuse score from the perspective of the elderly and family caregivers ،Results of  Assessment of Homestic Elder Abuse questionnaire and  Caregiver Abuse Screen. Timepoint: Beginning of the study (before the intervention) - End of the study (one week after the last session of the family-centered reminiscence intervention). Method of measurement: "Assessment of Homestic Elder Abuse questionnaire" and  "Caregiver Abuse Screen".</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>2022-03-15</approval_date>
        <contact_name>Ethics Committee of Mashhad University of Medical Sciences</contact_name>
        <contact_address>School of Nursing and Midwifery, Ibn Sina St., Doctora Crossroads, Daneshgah St, Mashhad, Khorasan Razavi. Mashhad Razavi Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
