<?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>IRCT20230812059127N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-11-01</date_registration>
      <primary_sponsor>Bojnourd University of Medical Sciences</primary_sponsor>
      <public_title>Investigating the effect of self-care training on behavior change in blood pressure control</public_title>
      <acronym></acronym>
      <scientific_title>Investigating the effect of self-care behavior training based on the 5A model on health self-care behaviors to control blood pressure in the elderly</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-10-07</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>90</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/72474</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Other, Purpose: Education/Guidance, Randomization description: 90 people who have been diagnosed with high blood pressure by a doctor and who meet the criteria for entering the study are selected easily from among those who refer to the hospital clinic of Babol University of Medical Sciences. After that, they will be randomly divided into 2 intervention and control groups. For this purpose, the cards with the test and control written on them are put in a box and each of the samples is asked to choose a card randomly, after that people with test cards in the test group and people who have a control card, are placed in the control group.</study_design>
      <phase>N/A</phase>
      <hc_freetext>hypertension.</hc_freetext>
      <i_freetext>Intervention 1: Control group: Referees are divided into two groups of 45 people, test and control. The first group will receive common treatments or the use of common drugs. Intervention 2: Intervention group: In addition to common treatments, the second group will also receive training on self-care behaviors based on the A5 model.The self-management program will be implemented for each patient in the test group in 5 stages during 12 weeks. In the first week of the research, the first, second and third stages will be implemented in the following order:First step: Examining the awareness, behaviors and beliefs of the patientStep 2: Counseling the patient about the health risks and benefits of behavior changeThe third step: agreement with the patient in the field of setting realistic goals(The first three stages will be done during a 2-hour session in one day)Step 4: Helping to develop a practical plan (with a family member)A 2-hour group training session will be held one week after individual guidance to increase the patient's awareness of their disease.Fifth step: follow upThen the performance of the patients will be followed for 12 weeks. In order to ensure the implementation of the practical plans by the patients in the first 2 weeks, phone calls will be made three times a week and after that weekly phone calls will be made with the patients to remind them to complete the practical plans. In addition, the progress of the patient will be followed up once every 4 weeks during a face-to-face meeting. In this meeting, the agreed program and the patient's self-report book will be reviewed so that essential changes can be made if needed.After the end of 12 weeks, the aforementioned questionnaires will be provided to the patients of both groups and they will be examined in terms of the studied variables.</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>Seyedeh Sadaf Bozorgnia Hosseini</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Sharifi Blvd. 13 Sharifi</address>
        <city>Babolsar</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4741745494</zip>
        <telephone>+98 11 3536 4129</telephone>
        <email>s.bozorgnia.h@gmail.com</email>
        <affiliation>Bojnourd University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Seyedeh Sadaf Bozorgnia Hosseini</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Sharifi Blvd. 13 Sharifi</address>
        <city>Babolsar</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4741745494</zip>
        <telephone>+98 11 3536 4129</telephone>
        <email>s.bozorgnia.h@gmail.com</email>
        <affiliation>Bojnourd University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age over 60 years
Diagnosis of hypertension for at least one year based on medical records
Having hypertension diagnosed by a doctor
Speak in persian
With the possibility of access and follow-up by phone</inclusion_criteria>
      <agemin>60 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Suffering from malignant diseases based on the medical history entered in the medical record
Suffering from heart failure based on the medical history entered in the medical record
Suffering from kidney failure based on the medical history recorded in the medical record
Suffering from hyperthyroidism based on the medical history recorded in the medical record
Suffering from depression and neurological diseases based on the medical history entered in the medical record</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>Control group: Referees are divided into two groups of 45 people, test and control. The first group will receive common treatments or the use of common drugs.</i_keyword>
      <i_keyword>Intervention group: In addition to common treatments, the second group will also receive training on self-care behaviors based on the A5 model.The self-management program will be implemented for each patient in the test group in 5 stages during 12 weeks. In the first week of the research, the first, second and third stages will be implemented in the following order:First step: Examining the awareness, behaviors and beliefs of the patientStep 2: Counseling the patient about the health risks and benefits of behavior changeThe third step: agreement with the patient in the field of setting realistic goals(The first three stages will be done during a 2-hour session in one day)Step 4: Helping to develop a practical plan (with a family member)A 2-hour group training session will be held one week after individual guidance to increase the patient's awareness of their disease.Fifth step: follow upThen the performance of the patients will be followed for 12 weeks. In order to ensure the implementation of the practical plans by the patients in the first 2 weeks, phone calls will be made three times a week and after that weekly phone calls will be made with the patients to remind them to complete the practical plans. In addition, the progress of the patient will be followed up once every 4 weeks during a face-to-face meeting. In this meeting, the agreed program and the patient's self-report book will be reviewed so that essential changes can be made if needed.After the end of 12 weeks, the aforementioned questionnaires will be provided to the patients of both groups and they will be examined in terms of the studied variables.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Behavior change. Timepoint: The Hypertension-Self-care Activity Level Effects questionnaire will be completed once at the beginning of the research and again after 12 weeks for both groups (test and control). Method of measurement: Hypertension-Self-care Activity Level Effects questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Hypertension. Timepoint: The systolic and diastolic blood pressure of the client is measured and recorded by the research assistant in two stages, the first week and the twelfth week respectively. Method of measurement: Mercury 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>Bojnourd University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-08-12</approval_date>
        <contact_name>Ethics Committee of North Khorasan University of Medical Sciences</contact_name>
        <contact_address>Dolat Blvd., Central Building of North Khorasan University of Medical Sciences, Bojnourd Bojnourd North Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
