<?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>IRCT20180527039870N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-07-04</date_registration>
      <primary_sponsor>The University of Tarbiat modares</primary_sponsor>
      <public_title>The effect of self-care program on hypertension</public_title>
      <acronym></acronym>
      <scientific_title>The effect of activity and spiritual health based self-care program on hypertension among the Kahrizak elderly people in the Alborz province.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-03-05</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>90</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/31807</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Factorial, Purpose: Supportive, Blinding description: Participants in the study were placed in separate groups so that they did not deal with each other.</study_design>
      <phase>3</phase>
      <hc_freetext>hypertension in the elderly.</hc_freetext>
      <i_freetext>Intervention 1: Control group: For 30 elderly people in the control group consent to participate in research and demographic, complete with Shd.fsharkhvn systolic and diastolic pressure gauge Japanese Yamasv in the morning and afternoon on three consecutive days to measure and record blood pressure at the Czech medical records and in the last 1.5 months without intervention seniors again in the morning and evening blood pressure measurements were recorded in the Czech list. Intervention 2: Intervention group: For the 30 aged people in the activity group, at first, the satisfaction of the company in the research and the demographic information questionnaire, the daily routine life questionnaire was completed for elderly in terms of physical activity and resting time during physical or physical activity. Then, elderly blood pressure at two times in the morning The age of measurement was recorded in the blood pressure check list. In the implementation section, the items of the daily life activity questionnaire were explained to the elderly in 5 dimensions and they were asked to perform their duties and duties according to the items of the daily life activities questionnaire. And register in the self-report checklist. In the follow up section, the researcher's presence was followed up within 3 weeks of the elderly's performance. At the end of the first 1.5 months, the questionnaire was completed daily living and elderly blood pressure was measured at two times in the morning and in the evening and recorded in the checklist. Intervention 3: Intervention group: For the 30 elderly in the self-care program group (spiritual activity), the consent of the company in the research and the demographic information questionnaire, the daily living practice questionnaire for assessing the elderly in terms of physical activities and resting time during physical or physical activity, as well as the questionnaire Spiritual health was completed. In the implementation section, the activities were followed in the same way as the second intervention group, and the spiritual health program was presented in different fields such as values (encouragement to help others), connecting point (listening to the verses of the verse, 3 times a week). 1.5 months later. The intervention was again completed and scaled.</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>Saeedeh Khalili</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Nasr briddge, Jalal All Ahmad St., Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>14115-111</zip>
        <telephone>+98 21 8288 3108</telephone>
        <email>saeedehkhalili@modares.ac.ir</email>
        <affiliation>Tarbiat Modares University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Saeedeh Khalili</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Nasr Briddge, Jalal All Ahmad St., Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>14115-111</zip>
        <telephone>+98 82883108</telephone>
        <email>saeedehkhalili@modares.ac.ir</email>
        <affiliation>Tarbiat Modares University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Elderly diagnosed as hypertensive disease by a specialist physician residing in center.
The age of the patient is 65 to 90 years old.
Older people have read and write literacy or ability to interview.
Have a tendency to participate and collaborate in research.</inclusion_criteria>
      <agemin>65 years</agemin>
      <agemax>90 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Illnesses caused by complications of hypertension or myocardial infarction during the study.
 Elderly death or leaving the sanatorium for any reason during the study</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>110</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Essential (primary) hypertension</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Control group: For 30 elderly people in the control group consent to participate in research and demographic, complete with Shd.fsharkhvn systolic and diastolic pressure gauge Japanese Yamasv in the morning and afternoon on three consecutive days to measure and record blood pressure at the Czech medical records and in the last 1.5 months without intervention seniors again in the morning and evening blood pressure measurements were recorded in the Czech list.</i_keyword>
      <i_keyword>Intervention group: For the 30 aged people in the activity group, at first, the satisfaction of the company in the research and the demographic information questionnaire, the daily routine life questionnaire was completed for elderly in terms of physical activity and resting time during physical or physical activity. Then, elderly blood pressure at two times in the morning The age of measurement was recorded in the blood pressure check list. In the implementation section, the items of the daily life activity questionnaire were explained to the elderly in 5 dimensions and they were asked to perform their duties and duties according to the items of the daily life activities questionnaire. And register in the self-report checklist. In the follow up section, the researcher's presence was followed up within 3 weeks of the elderly's performance. At the end of the first 1.5 months, the questionnaire was completed daily living and elderly blood pressure was measured at two times in the morning and in the evening and recorded in the checklist.</i_keyword>
      <i_keyword>Intervention group: For the 30 elderly in the self-care program group (spiritual activity), the consent of the company in the research and the demographic information questionnaire, the daily living practice questionnaire for assessing the elderly in terms of physical activities and resting time during physical or physical activity, as well as the questionnaire Spiritual health was completed. In the implementation section, the activities were followed in the same way as the second intervention group, and the spiritual health program was presented in different fields such as values (encouragement to help others), connecting point (listening to the verses of the verse, 3 times a week). 1.5 months later. The intervention was again completed and scaled.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Percentage of people with hypertension above 140/90. Timepoint: Measuring hypertension at the beginning of the study three consecutive days at two times in the morning and at night, and then at the end of the study three consecutive days at two times in the morning and evening after the presentation of the training program. Method of measurement: Yamasu counter barometer.</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>The University of Tarbiat modares</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2016-12-11</approval_date>
        <contact_name>Ethics Committee of Tarbiat Modarres University</contact_name>
        <contact_address>Tehran Jalal Al Ahmad Nasr Bridge Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
