<?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>IRCT20140427017454N6</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-10-06</date_registration>
      <primary_sponsor>Zanjan University of Medical Sciences</primary_sponsor>
      <public_title>Comparison of the effect of education through social networks with face-to-face teaching on adherence to treatment in patients with hypertension</public_title>
      <acronym></acronym>
      <scientific_title>A comparison of the effect of education through social networks with face-to-face teaching on adherence to treatment in patients with hypertension</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-10-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>210</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/66175</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: The distribution of patients in three groups will be by using the randomized block design. Based on this, the patients who meet the inclusion criteria will be equally distributed into three groups; Intervention group A (virtual training), B (face-to-face training), and C (control group). Since we will have three groups in this study, it is planned to have blocks of six in number. In the random distribution of patients in three groups, all possible forms of blocks with the equal presence of all three groups will be determined and placed inside separate envelopes. The project manager will randomly select the envelopes and inform the sampler of each patient's grouping order. For example, Block NO one may be arranged as AABBCC; This means that the first and second eligible patients will be assigned to intervention group A (virtual education), the following two patients to the face-to-face education group (group B), and the subsequent two patients to the control group (group C), Blinding description: Due to the study's design, only blinding will be possible for the statistical analysis stage of the data. In other words, the statistician will be unaware of the participating groups.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Hypertension.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group (face-to-face): The way of conducting the educational intervention in the face-to-face group will be that it will be done once a week on Tuesday at the appointed time for four weeks with the coordination of the patients of this group. The patients of this group attend an educational class at the scheduled time in the heart clinics of Valiasr and Ayatollah Mousavi hospitals in Zanjan city. In the first session (first week), lectures, questions, and answers will give educational information related to the nature of high blood pressure disease and the effective factors to cause it. In the second session (second week), the content taught in the previous week is reviewed, and then the patients of this group are taught how to control high blood pressure and the importance of controlling it with the help of PowerPoint.In the third session (third week), while reviewing the contents of the previous two sessions and questions and answers related to the learned content, educational information regarding the importance of following the drug and behavioral regimen and its effect on blood pressure control in the form of a lecture and using It is presented from the lecture. In the fourth session (the last week), the content taught in the previous sessions will be summarized. Then the patients will be taught how to measure blood pressure using the blood pressure device. In the next step, the volunteers will be asked to measure the blood pressure of other peers in the researcher's presence. Finally, patients are advised to teach the learned method to their family members so that family members can regularly control their blood pressure. Intervention 2: Intervention group (virtual): First, a group is created in one of the virtual software, such as WhatsApp, and sample members enter the group. Then, the educational content of the first session, which is related to the nature of hypertension and the factors affecting it, are sent to the group in the form of text and voice. The patients are told that they can discuss their problems in the group if they have any doubts or questions. Or they discuss it privately with the group manager (researcher). In the second session, educational information on how to control high blood pressure and the importance of controlling it will be sent in the form of a PowerPoint and pictures. In the third session, the importance of following the medication and behavioral regimen and its effect on controlling high blood pressure will be discussed, which will be sent to the group in the form of text, voice, and educational clips. In the last session, an educational clip related to the method of measuring systolic and diastolic blood pressure using a blood pressure device, along with additional explanations in the form of text and voice, will be sent to the group. At the end of the session, we will encourage the patients to teach the learned method to their family members so that their blood pressure can be controlled regularly by family members.</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:
All data will be shared after the de-identification of study participants and publication of results.

When:
The data availability period will start immediately after the results are published.

To whom:
Only researchers working in academic and scientific research centers and nurses working in hospitals can access the data of this study.

Conditions:
Suppose the purpose of accessing the data is to develop research projects in the future or improve services to patients. The condition of access to the data will be a written and reasonable request of the applicant.

Where to obtain:
Those who are interested in receiving the data can send an email to the project manager at Korosh@zums.ac.ir.

How to obtain:
The applicant can receive the data during an email while introducing himself and the purpose of accessing the data. The maximum response time to the requester will be one week.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Kourosh Amini</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Dr Sobouti (Gavazang) Blvd., Central Campus of Zanjan University of Medical Science., School of Nursing and Midwifery</address>
        <city>Zanjan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4513956113</zip>
        <telephone>+98 24 3314 8318</telephone>
        <email>korosh@zums.ac.ir</email>
        <affiliation>Zanjan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Kourosh Amini</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Dr Sobouti (Gavazang) Blvd., Central Campus of Zanjan University of Medical Science., School of Nursing and Midwifery</address>
        <city>Zanjan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4513956113</zip>
        <telephone>+98 24 3314 8318</telephone>
        <email>korosh@zums.ac.ir</email>
        <affiliation>Zanjan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Over 18 years of age
Having a history of hypertension for at least six months, which a cardiologist confirmed.
Being literate in reading and writing
Not having secondary, and treatment-resistant hypertension
Absence of severe mental/psychological disturbances
Having the patient's own smart cell phone and access to the Internet
Having informed consent to participate in the study</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Concurrent participation in another study or similar educational program
Impossibility to continue participating in the study for any reason
Not completing data gathering tools</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>I10</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Essential (primary) hypertension</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Behavior</i_code>
      <i_code>Behavior</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group (face-to-face): The way of conducting the educational intervention in the face-to-face group will be that it will be done once a week on Tuesday at the appointed time for four weeks with the coordination of the patients of this group. The patients of this group attend an educational class at the scheduled time in the heart clinics of Valiasr and Ayatollah Mousavi hospitals in Zanjan city. In the first session (first week), lectures, questions, and answers will give educational information related to the nature of high blood pressure disease and the effective factors to cause it. In the second session (second week), the content taught in the previous week is reviewed, and then the patients of this group are taught how to control high blood pressure and the importance of controlling it with the help of PowerPoint.In the third session (third week), while reviewing the contents of the previous two sessions and questions and answers related to the learned content, educational information regarding the importance of following the drug and behavioral regimen and its effect on blood pressure control in the form of a lecture and using It is presented from the lecture. In the fourth session (the last week), the content taught in the previous sessions will be summarized. Then the patients will be taught how to measure blood pressure using the blood pressure device. In the next step, the volunteers will be asked to measure the blood pressure of other peers in the researcher's presence. Finally, patients are advised to teach the learned method to their family members so that family members can regularly control their blood pressure.</i_keyword>
      <i_keyword>Intervention group (virtual): First, a group is created in one of the virtual software, such as WhatsApp, and sample members enter the group. Then, the educational content of the first session, which is related to the nature of hypertension and the factors affecting it, are sent to the group in the form of text and voice. The patients are told that they can discuss their problems in the group if they have any doubts or questions. Or they discuss it privately with the group manager (researcher). In the second session, educational information on how to control high blood pressure and the importance of controlling it will be sent in the form of a PowerPoint and pictures. In the third session, the importance of following the medication and behavioral regimen and its effect on controlling high blood pressure will be discussed, which will be sent to the group in the form of text, voice, and educational clips. In the last session, an educational clip related to the method of measuring systolic and diastolic blood pressure using a blood pressure device, along with additional explanations in the form of text and voice, will be sent to the group. At the end of the session, we will encourage the patients to teach the learned method to their family members so that their blood pressure can be controlled regularly by family members.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Treatment adherence. Timepoint: Before the intervention, immediately after the intervention, one month after the intervention, and three months after the intervention. Method of measurement: The Medication Adherence Questionnaire (MAQ).</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>Zanjan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-09-29</approval_date>
        <contact_name>Ethics committee of Shiraz University of Medical Sciences</contact_name>
        <contact_address>Azadi boulevard Zanjan Zanjan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
