<?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>IRCT20191127045524N4</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-09-15</date_registration>
      <primary_sponsor>Shahroud University of Medical Sciences</primary_sponsor>
      <public_title>The Effect of Training Health Volunteers on Ageing Abuse</public_title>
      <acronym></acronym>
      <scientific_title>The Effect of the Training Program for Health Volunteers to the Ageing on Ageing Abuse: A Parallel Randomized Clinical Trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-09-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>80</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/72429</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: The random allocation sequence is obtained by the methodology consultant with the software. Eligible patients are registered by two people trained by the researcher. Allocation of participants to interventions is done by a trained nurse. In order to hide the random allocation, the names of the groups will be placed in a sealed envelope in the sequence of random allocation. Envelopes are numbered. People get a code in the order of their entry into the study, and an envelope is opened for each person and assigned to the desired group. It will be determined by SPSS software to create a random allocation sequence from the block method to quadruple volume. Patients will be selected based on the researcher's desired criteria and will be randomly placed in two groups A (test) and B (control group) based on the order determined by Spss software. The order of randomization will be done secretly; It means that there are 80 envelopes in the package, each of which contains code A and B. After obtaining informed consent and determining that the desired person participates in the study, the person trained by the researcher takes the desired envelope in the specified order and acts according to the group registered in the envelope.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Ageing Abuse.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: The first, related training such as the definition of ageing abuse, its recognition, its types, and prevention and notification strategies are given to the health volunteers by the researcher and a nurse trained by the researcher during a session, and then with the coordination of the health volunteers with During two face-to-face and group sessions for one hour, the elderly provide training on the issue of ageing abuse and its dimensions, as well as ways to prevent and report it. At the end of the second session, people will be given an educational pamphlet about ageing abuse. After selecting the people of the test group based on the entry criteria and obtaining informed consent, the trainings are conducted in the same comprehensive health service centers. Health volunteers in comprehensive health centers will talk to the ageing on a weekly basis through phone calls to investigate and answer their questions. After 4 weeks, the people of the test and control groups are again asked to be evaluated by a questionnaire related to ageing abuse. Intervention 2: Control group: Ageing people who refer to community health centers receive care and routine training of the 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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
Part of the patient's demographic information is shared after people have not been identified. All information related to measuring worry and blood pressure in patients can be shared after people have not been identified.

When:
Access starts 6 months after results are published

To whom:
Researchers and students of academic and scientific institutions

Conditions:
Raw data for correlation studies

Where to obtain:
amirheidari770@gmail.com

How to obtain:
Clear explanation of the reason for the need to access data and provide data after two weeks

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Amirheidar Bakhshiarab</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>7th Square, Research and Technology, Shahroud University Medical Science, Shahroud Town</address>
        <city>Shahroud</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3614773955</zip>
        <telephone>+98 23 3222 4816</telephone>
        <email>amirheidari770@gmail.com</email>
        <affiliation>Shahroud University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Amirheidar Bakhshiarab</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>7th Square, Research and Technology, Shahroud University Medical Science, Shahroud Town</address>
        <city>Shahroud</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3614773955</zip>
        <telephone>+98 23 3222 4816</telephone>
        <email>amirheidari770@gmail.com</email>
        <affiliation>Shahroud University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age 60 years and older
understanding and speaking Persian language
history of or being abused by the elderly based on the Vulnerability to Abuse Screening Scale (VASS-21) questionnaire score
obtaining a cognitive ability score based on the Mental Status Assessment of Older Adults (Mini-Cog) test
obtaining an individual independence score on the Activities of Daily Living (ADL) test</inclusion_criteria>
      <agemin>60 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Having a background of depression based on the Geriatric Depression Scale (GDS-15) test</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>Y07.9</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Unspecified perpetrator of maltreatment and neglect</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: The first, related training such as the definition of ageing abuse, its recognition, its types, and prevention and notification strategies are given to the health volunteers by the researcher and a nurse trained by the researcher during a session, and then with the coordination of the health volunteers with During two face-to-face and group sessions for one hour, the elderly provide training on the issue of ageing abuse and its dimensions, as well as ways to prevent and report it. At the end of the second session, people will be given an educational pamphlet about ageing abuse. After selecting the people of the test group based on the entry criteria and obtaining informed consent, the trainings are conducted in the same comprehensive health service centers. Health volunteers in comprehensive health centers will talk to the ageing on a weekly basis through phone calls to investigate and answer their questions. After 4 weeks, the people of the test and control groups are again asked to be evaluated by a questionnaire related to ageing abuse.</i_keyword>
      <i_keyword>Control group: Ageing people who refer to community health centers receive care and routine training of the center.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Investigation of Ageing Abuse with Vulnerability to Abuse Screening Scale (VASS-21) questionnaire. Timepoint: At the beginning of the study (before the intervention) and 4 weeks after the intervention. Method of measurement: The VASS-21Ageing Abuse Questionnaire and the cut point score of 3 and above indicates the potential risk of elder abuse.</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>Shahroud University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-09-04</approval_date>
        <contact_name>Ethics Committee in Research of Shahroud University of Medical Sciences</contact_name>
        <contact_address>7th Square, Research and Technology, Shahroud University of Medical Science, Shahroud Town Shahroud Semnan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
