<?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>IRCT20221024056283N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-11-09</date_registration>
      <primary_sponsor>Tehran University of Medical Sciences</primary_sponsor>
      <public_title>the impact of self-care education on loneliness and social isolation among older adults.</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the impact of self-care education through mobile learning and lecture method on loneliness and social isolation among community-dwelling older adults.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-12-06</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>144</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/66595</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: For the random allocation of samples in three groups, the method of block random assignment  from www.randomizer.org will be used. The size of the blocks will be 6. Concealment of the random allocation of samples in three groups will be done by dark-colored envelopes according to the number of samples.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Condition 1: loneliness. Condition 2: social isolation.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group 1: The intervention of the mobile learning group: The educational content of the mobile learning group, based on Mobile Health, is provided through the designed software. The application is designed and implemented by the researcher with Java programming language by Android Studio. This application is an offline educational software that can be installed on the Android operating system. The application environment will be designed according to the specific needs of the elderly, so that changes such as reduced muscle strength and limitations in performing precise tasks, reduced visual acuity, reduced color perception and greater sensitivity to staring at the screen, will be customized and adjusted in such a way that To make the elderly benefit from the educational content to the maximum, and in addition to being easy to use, it is possible to use a suitable and adjustable font and color contrast. With the aim of increasing the attention, efficiency and use of different senses of the elderly, the educational content will be in the form of multimedia (text message and/or educational video and/or audio message) and in the form of 8 training sessions and two sessions per week for The time will be about 30 minutes for each session, which will include different dimensions of self-care (including physical self-care, psycho-emotional self-care, social self-care and spiritual self-care). The first meeting will be conducted face-to-face to state the objectives of the research, explain the educational program (educational chart), how to access the researcher for questions and clear possible doubts, how to install and use the software. After installing the software, the access code for the people of this group will be entered by the researcher. so that other people under study do not have access to educational content; The login code to the software will not be shared with the mobile learning group. The second to seventh educational sessions will be provided to the elderly of the mobile learning group by mobile phone application. The order of loading the content in the application will be done according to the educational chart presented in the first session, and until the content of the previous session is not studied, the next session will not be visible to the elderly. At the end of each week, follow-up will be done to ensure that the educational content is read by the mobile learning group, through a phone call or text message. Also, during the  intervention, the researcher will be available to the people of this group by phone or via text message if they have questions or need additional explanations. The last meeting will be held in person with the purpose of summarizing the contents, questions and answering the post-test. Intervention 2: Intervention group 2: The intervention of the training group in the way of lectures: Physical self-care, psycho-emotional self-care, social self-care, and spiritual self-care training will be held in the form of group lectures, using educational aids such as marker, blackboard, and PowerPoint in small groups of 8 to 10 people. Training will be provided in 6 sessions and 2 sessions each week for a duration of approximately 45 to 60 minutes for each session. These trainings will be conducted at the selected comprehensive health service center. At the end of each session, a group discussion will be held with the participation of the members of this group. Intervention 3: Control group: There is no intervention for the control group; But at the end of the research, the content of self-care training will be given to the people of this group.</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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is "There is no further information".</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mehrnoosh Partovirad</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Tehran University of Medical Sciences Girls' Dormitory ,in front of Al-Nabi Mosque,The end of North Kargar, North Kargar.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1439957181</zip>
        <telephone>+98 51 4262 1206</telephone>
        <email>partovirad76@gmail.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mehrnoosh Partovirad</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Tehran University of Medical Sciences Girls' Dormitory ,in front of Al-Nabi Mosque,The end of North Kargar, North Kargar</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1439957181</zip>
        <telephone>+98 51 4262 1206</telephone>
        <email>partovirad76@gmail.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>1. 60-70 years old based on WHO criteria,                                 2.The ability to perform Activities of Daily Living and not having the history of Psychological disorders based on self-report and the elderly medical file,                                                                       3. Being literate,                                                                                  4. Having a smart mobile phone with the Android operating system,                                                                                                 5. The ability to use a mobile phone and educational software,    6. Not participating in similar training courses,                               7. The absence of hearing, vision, touch and speech disorders.</inclusion_criteria>
      <agemin>60 years</agemin>
      <agemax>70 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>1. Non-participation of research samples for at least two sessions,                                                                                              2. Suffering from a severe illness or disability.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>Z60</hc_code>
      <hc_code>Z60.4</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Problems related to social environment</hc_keyword>
      <hc_keyword>Social exclusion and rejection</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Lifestyle</i_code>
      <i_code>Lifestyle</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group 1: The intervention of the mobile learning group: The educational content of the mobile learning group, based on Mobile Health, is provided through the designed software. The application is designed and implemented by the researcher with Java programming language by Android Studio. This application is an offline educational software that can be installed on the Android operating system. The application environment will be designed according to the specific needs of the elderly, so that changes such as reduced muscle strength and limitations in performing precise tasks, reduced visual acuity, reduced color perception and greater sensitivity to staring at the screen, will be customized and adjusted in such a way that To make the elderly benefit from the educational content to the maximum, and in addition to being easy to use, it is possible to use a suitable and adjustable font and color contrast. With the aim of increasing the attention, efficiency and use of different senses of the elderly, the educational content will be in the form of multimedia (text message and/or educational video and/or audio message) and in the form of 8 training sessions and two sessions per week for The time will be about 30 minutes for each session, which will include different dimensions of self-care (including physical self-care, psycho-emotional self-care, social self-care and spiritual self-care). The first meeting will be conducted face-to-face to state the objectives of the research, explain the educational program (educational chart), how to access the researcher for questions and clear possible doubts, how to install and use the software. After installing the software, the access code for the people of this group will be entered by the researcher. so that other people under study do not have access to educational content; The login code to the software will not be shared with the mobile learning group. The second to seventh educational sessions will be provided to the elderly of the mobile learning group by mobile phone application. The order of loading the content in the application will be done according to the educational chart presented in the first session, and until the content of the previous session is not studied, the next session will not be visible to the elderly. At the end of each week, follow-up will be done to ensure that the educational content is read by the mobile learning group, through a phone call or text message. Also, during the  intervention, the researcher will be available to the people of this group by phone or via text message if they have questions or need additional explanations. The last meeting will be held in person with the purpose of summarizing the contents, questions and answering the post-test.</i_keyword>
      <i_keyword>Intervention group 2: The intervention of the training group in the way of lectures: Physical self-care, psycho-emotional self-care, social self-care, and spiritual self-care training will be held in the form of group lectures, using educational aids such as marker, blackboard, and PowerPoint in small groups of 8 to 10 people. Training will be provided in 6 sessions and 2 sessions each week for a duration of approximately 45 to 60 minutes for each session. These trainings will be conducted at the selected comprehensive health service center. At the end of each session, a group discussion will be held with the participation of the members of this group.</i_keyword>
      <i_keyword>Control group: There is no intervention for the control group; But at the end of the research, the content of self-care training will be given to the people of this group.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Loneliness score in the elderly, which is measured by the loneliness inventory for older adults. Timepoint: The measurement of loneliness in the elderly will be at the beginning of the study (before the start of the intervention) and after the end of the intervention and then 3 months after the end of the intervention. Method of measurement: The way to measure the feeling of loneliness in the elderly is the self-report tool of the loneliness inventory for older adults made by Bandari (2021) in Iran.</prim_outcome>
      <prim_outcome>The score of social isolation in the elderly, which is measured by the Lubben Social Network Scale (LSNS). Timepoint: The measurement of social isolation in the elderly will be at the beginning of the study (before the start of the intervention) and after the end of the intervention and then 3 months after the end of the intervention. Method of measurement: The way to measure the social isolation in the elderly is the self-report tool of the Lubben Social Network Scale for older adults made by Lubben (2006) in Switzerland.</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>Tehran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-09-28</approval_date>
        <contact_name>Ethics committee of Tehran University of Medical Sciences</contact_name>
        <contact_address>Tehran University of Medical Sciences Girls' Dormitory ,in front of Al-Nabi Mosque,The end of North Kargar, North Kargar Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
