<?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>IRCT20201105049279N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-12-25</date_registration>
      <primary_sponsor>Deputy of research  and technology of Sabzevar University of Medical Sciences</primary_sponsor>
      <public_title>Effect of Tele- Nursing on blood pressure control and Self-care behaviors</public_title>
      <acronym></acronym>
      <scientific_title>The effect of Tele-Nursing on blood pressure control and Self-care behaviors in patients with chronic hypertension referred to comprehensive urban and rural health service centers in Garmeh- in 2020.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-12-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>41</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/52148</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: First, by coin tossing randomly select 5 centers by cluster approach among 10 comprehensive urban health service centers (6 centers) and rural (4 centers). In this way, among the 5 clusters, the samples are randomly divided into two group of control and intervention based on permuted random blocks sampling (urban and rural). That is, we can randomly select samples by making 20 *4 blocks. In this part, we can also choose the two groups of control and intervention by dropping coins.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Hypertension.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: in the intervention group, in addition to the virtual training session that is held for all research samples, remote nursing (counseling and telephone follow-up) will be performed by researchers for 3 months. In this way, telephone calls are made to follow up blood pressure control and self-care behaviors twice a week in the first month and once a week during the second and third months, with members of the intervention group.The duration of the conversation will be estimated at an average of 15 minutes and the researcher will be able to contact patients during office hours. The content of the conversations included introducing themselves, asking about the general health status of the participants, encouraging them to follow the recommendations and aspects of public and private care, following up on training needs based on their training needs, providing suggested solutions and answering questions. They will be. Phone calls and their content will be recorded for each participant in specific tabs to be re-evaluated in subsequent calls. Intervention 2: Control group: During the intervention, the control group will receive standard treatment. This treatment includes medication and training on how to take medication and adhere to a changing diet, lifestyle and physical activity.</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 No decision has been made yet</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Fatemeh Talebi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Nurse Street - between Nurse 3 and 5</address>
        <city>Garmeh</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9431644166</zip>
        <telephone>+98 58 3250 3545</telephone>
        <email>Amir.talebi325035@gmail.com</email>
        <affiliation>Sabzevar University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Fatemeh Talebi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Nurse Street - between Nurse 3 and 5</address>
        <city>Garmeh</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9431644166</zip>
        <telephone>+98 58 3250 3545</telephone>
        <email>Amir.talebi325035@gmail.com</email>
        <affiliation>Sabzevar University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Being between 30 and 75 years old
Indigenous (resident of Garmeh city)
Phone access
Confirmation of high blood pressure by a family doctor and having a file in the Comprehensive Health Service Center
At least 6 months of history of hypertension (duration of the disease is more than 6 months)
Taking at least one anti hypertensive drug by the patient
Do not have dialysis patients
No debilitating disease
Lack of cognitive impairment
No substance abuse
Ability to speak and understand Persian by the patient and her companion
Have reading and writing literacy to complete the questionnaire
Willingness and satisfaction to participate in the study</inclusion_criteria>
      <agemin>30 years</agemin>
      <agemax>75 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Having speech and hearing impairments
Participating in a similar training course during the last 6 months</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>Other</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: in the intervention group, in addition to the virtual training session that is held for all research samples, remote nursing (counseling and telephone follow-up) will be performed by researchers for 3 months. In this way, telephone calls are made to follow up blood pressure control and self-care behaviors twice a week in the first month and once a week during the second and third months, with members of the intervention group.The duration of the conversation will be estimated at an average of 15 minutes and the researcher will be able to contact patients during office hours. The content of the conversations included introducing themselves, asking about the general health status of the participants, encouraging them to follow the recommendations and aspects of public and private care, following up on training needs based on their training needs, providing suggested solutions and answering questions. They will be. Phone calls and their content will be recorded for each participant in specific tabs to be re-evaluated in subsequent calls.</i_keyword>
      <i_keyword>Control group: During the intervention, the control group will receive standard treatment. This treatment includes medication and training on how to take medication and adhere to a changing diet, lifestyle and physical activity.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Blood pressure control. Timepoint: pre and post intervention. Method of measurement: Use of self-care questionnaire and Abbreviated Mental Test(AMTs).</prim_outcome>
      <prim_outcome>Self-care behaviors. Timepoint: pre and post intervention. Method of measurement: Self-care behavior control.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Blood pressure control. Timepoint: Pre and post intervention. Method of measurement: By sphygmomanometer.</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>Deputy of research  and technology of Sabzevar University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-12-20</approval_date>
        <contact_name>Ethics Committee of Sabzevar University of Medical Sciences</contact_name>
        <contact_address>Sabzevar, Nuclear Martyrs Boulevard, Above the Unknown Martyrs, Campus of the University of Medical Sciences, Office of the Vice President for Research and Technology Sabzevar Razavi Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
