<?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>IRCT20210910052427N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-09-17</date_registration>
      <primary_sponsor>Tehran University of Medical Sciences</primary_sponsor>
      <public_title>The Effect of Fall Prevention Education with Video on the Occurrence of Fall and Fear of it (Fall) in Hospitalized Elderly</public_title>
      <acronym></acronym>
      <scientific_title>Evaluation of the Effect of Fall Prevention Education with Video on Fall Occurrence and Fear of it (Fall) among Older Hospital Inpatients</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-09-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>132</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/58657</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: the samples are allocated by the block random allocation method in two groups of control and intervention. Depending on the sample size, 33 blocks of 4 are required for random allocation. The intervention group will be displayed with A and the control group with B. The website https://www.Randomization.com will be used to randomly determine the blocks, Blinding description: In order to hide the random allocation from the researcher, a dark envelope sample size is prepared and each of the random sequences created is recorded on a card and placed inside the envelope. At the beginning of the registration of individuals, according to the order of arrival of the samples, one of the envelopes is opened in order and the assigned group of that sample is specified.</study_design>
      <phase>N/A</phase>
      <hc_freetext>fall occurrence and fear of it.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: The intervention in the form of two short educational videos is less than 15 minutes in total. In these videos, the patient gets acquainted with the importance of the fall and its prevalence, the consequences of the fall, the risk factors for the fall, and how to use these mobility devices, as well as how to adjust the risk factors. The film is provided to the intervention group with the help of the researcher's mobile phone. Intervention 2: Control group: The control group will not receive any intervention and will benefit from the usual training in the ward. But at the end of the study, in order to observe the ethics in the research and if the educational video is effective on the fall occurrence and the fear of it, this video will be provided to the control group via WhatsApp.</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:
In this study, all the information obtained after completing the fall and fear of falling questionnaire and after not identifying people can be shared.

When:
Access period starts 6 months after the results are published

To whom:
Researchers working in academic and scientific institutions

Conditions:
All researchers working in academic and scientific institutes can use the results of this study without any preconditions

Where to obtain:
Shahzad Pashaeipour, Associate Professor of Nursing, Department of Community Health Nursing and Elderly Nursing, School of Nursing and Midwifery, Tehran University of Medical Sciences 00989124913843
sh-pashaeipour@tums.ac.ir Postal code: 1419733171

How to obtain:
Without providing any specific documentation, the information will be available to them as soon as possible in the form of set instructions

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Shahzad Pashaeypoor</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Tehran, Tohid Square,  Nosrat Sharghi St, School of Nursing and Midwifery, Tehran University of Medical Sciences</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1419733171</zip>
        <telephone>+98 21 6105 4207</telephone>
        <email>sh-pashaeipour@tums.ac.ir</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Shahzad Pashaeypoor</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Tehran, Tohid Square,  Nosrat Sharghi St, School of Nursing and Midwifery, Tehran University of Medical Sciences</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1419733171</zip>
        <telephone>+98 21 6105 4207</telephone>
        <email>sh-pashaeipour@tums.ac.ir</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients over 60 years of age
Patients who have the ability to walk and move in the ward
Patients who have the ability to communicate and speak in Persian
Patients who have at least one history of falls before hospitalization
Patients who have been hospitalized for more than a week</inclusion_criteria>
      <agemin>60 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Patients with functional dependence
Patients with psychological memory impairment
Patients who have a history of participating in fall prevention education programs</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: The intervention in the form of two short educational videos is less than 15 minutes in total. In these videos, the patient gets acquainted with the importance of the fall and its prevalence, the consequences of the fall, the risk factors for the fall, and how to use these mobility devices, as well as how to adjust the risk factors. The film is provided to the intervention group with the help of the researcher's mobile phone</i_keyword>
      <i_keyword>Control group: The control group will not receive any intervention and will benefit from the usual training in the ward. But at the end of the study, in order to observe the ethics in the research and if the educational video is effective on the fall occurrence and the fear of it, this video will be provided to the control group via WhatsApp.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Fear of Falling in the International Scale of Fall Efficiency. Timepoint: Before the start of the study, at the time of discharge, one and three months after discharge will be completed by the two control and test groups. Method of measurement: Questionnaire International Fall Efficiency Scale.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Percentage of people who have fallen. Timepoint: Before the start of the study, at the time of discharge, one and three months after discharge will be completed by the two control and test groups. Method of measurement: Fall Questionnaire.</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>Tehran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-08-04</approval_date>
        <contact_name>Working Group / Research Ethics Committee School of Nursing and Midwifery and School of Rehabilitati</contact_name>
        <contact_address>Faculty of Nursing and Midwifery, Tehran University of Medical Sciences, Tohid Square, East Nosrat St., Tehran Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
