<?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>IRCT20210420051024N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-07-07</date_registration>
      <primary_sponsor>Yasouj University of Medical Sciences</primary_sponsor>
      <public_title>The effect of self-care program training in two methods of SMS service and face-to-face training on coping styles of patients undergoing hemodialysis</public_title>
      <acronym></acronym>
      <scientific_title>The effect of self-care program training in two methods of SMS service and face-to-face training on coping styles of patients undergoing hemodialysis</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-09-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>80</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/56782</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Random block allocation in such a way that first by multiplying the number of studied groups (two groups) by 2, the number of samples of each block is calculated equal to 4, then by factorial calculation, the number of samples of each block (4!= 4×3×2×1=24), the number of blocks resulting from all the modes of arrangement of individuals, 24 blocks are calculated, then, since the number of individuals in each block was 4, so using the Sample Randomizer software, how to arrange the research sample and assign each number One of the intervention groups 1 (SMS service) and intervention 2 (face to face) will be identified and a random block allocation list will be compiled. Then, qualified research samples will be selected and based on the time priority of the referral, a code will be assigned to each of them. By matching that number with the block random allocation list, the patients participating in the study will be assigned to One of the intervention groups 1 (SMS service) and intervention 2 (face to face) will be assigned.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Patients undergoing hemodialysis.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group 1: SMS service: Training in this group will be such that messages related to self-care will be sent via mobile phone. Patients' mobile phones will be checked for the Persian menu and how to use the SMS service will be explained to them and the existing problems and questions will be answered. Also, one of the prepared messages will be sent to those present. To ensure that the messages are sent, the researcher will activate the option on his / her mobile phone and the phrase "delivered" by checking the message received by the patients, will ensure the timely and correct receipt of the message by the participants. One message will be sent to the research units every day, so that 60 short messages will be sent in 2 months. The maximum text of each message will not be more than 160 characters. Each message will be numbered and will be marked in front of the message for each message delivered to patients. If no more than two messages are sent, the patient's landline number will be contacted and the cause will be sought, and if necessary, another mobile number will be received from the patient or a family member living with him or her. A short message will be sent to the new number. Intervention 2: Intervention group 2: Face to face: Training in this group will be in 8 sessions, the duration of each session will be one hour and one session per week (on days when patients are not on dialysis). Individuals will be categorized into groups of 5 to 10 people. Intervention 3: Control group: Non-intervention: This training group will not be given.</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 No more information.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Ali Torabiasl</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Unit 6, Baran Building, Iman St., next to Imam Khomeini Mosque, Yasuj</address>
        <city>Yasuj</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7591794857</zip>
        <telephone>+98 74 3322 4721</telephone>
        <email>ali.torabi1155@gmail.com</email>
        <affiliation>Yasouj University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Ali Torabiasl</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Unit 6, Baran Building, Iman St., next to Imam Khomeini Mosque, Yasuj</address>
        <city>Yasuj</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7591794857</zip>
        <telephone>+98 74 3322 4721</telephone>
        <email>ali.torabi1155@gmail.com</email>
        <affiliation>Yasouj University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Ability to communicate and answer questions by patients or with the patient
Being over 18 years old
Consent to participate in the study and sign the informed consent form
No anxiety disorders
At least 3 months after hemodialysis
Having a mobile phone</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Taking anti-anxiety and anti-depressant drugs
Previous participation in studies similar to current research
Diagnosed with self-reported mental illness and other chronic physical illnesses</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>N18.5</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Chronic kidney disease, stage 5</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Lifestyle</i_code>
      <i_code>Lifestyle</i_code>
      <i_code>Lifestyle</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group 1: SMS service: Training in this group will be such that messages related to self-care will be sent via mobile phone. Patients' mobile phones will be checked for the Persian menu and how to use the SMS service will be explained to them and the existing problems and questions will be answered. Also, one of the prepared messages will be sent to those present. To ensure that the messages are sent, the researcher will activate the option on his / her mobile phone and the phrase "delivered" by checking the message received by the patients, will ensure the timely and correct receipt of the message by the participants. One message will be sent to the research units every day, so that 60 short messages will be sent in 2 months. The maximum text of each message will not be more than 160 characters. Each message will be numbered and will be marked in front of the message for each message delivered to patients. If no more than two messages are sent, the patient's landline number will be contacted and the cause will be sought, and if necessary, another mobile number will be received from the patient or a family member living with him or her. A short message will be sent to the new number.</i_keyword>
      <i_keyword>Intervention group 2: Face to face: Training in this group will be in 8 sessions, the duration of each session will be one hour and one session per week (on days when patients are not on dialysis). Individuals will be categorized into groups of 5 to 10 people.</i_keyword>
      <i_keyword>Control group: Non-intervention: This training group will not be given.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Coping styles. Timepoint: The extent of patients' coping styles at the beginning of the study (before the intervention) and one month after the start of the study. Method of measurement: Jalowiec Coping Scale.</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>Yasouj University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-05-15</approval_date>
        <contact_name>Ethics committee of Yasuj University of Medical Sciences</contact_name>
        <contact_address>Yasuj University of Medical Sciences, Shahid Motahari Blvd., Yasuj, Kohgiluyeh and Boyer-Ahmad, Islamic Republic of Iran Yasuj Kohgilouyeh-va-Boyrahmad Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
