<?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>IRCT20100829004655N7</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-01-22</date_registration>
      <primary_sponsor>Kashan University of Medical Sciences</primary_sponsor>
      <public_title>Effect of use health promotion Pender's Model on Adherence to Treatment and Blood Pressure in Patients with Hypertension</public_title>
      <acronym></acronym>
      <scientific_title>Effect of use health promotion Pender's Model on Adherence to Treatment and Blood Pressure in Patients with Hypertension</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-01-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>80</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/4991</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Other design features: Individuals in the intervention and control groups, randomly allocated blocks (blocks 4-procurement and selection will be based on them), Randomization description: The sampling method is continuous and patients are divided into 4 randomized blocks between intervention and control groups, Blinding description: Patients are invited to participate in the study and as knowledge and purpose of the study are aware, after obtaining informed consent in the intervention and control groups sorted but they are not aware of this classification in the control or intervention group.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Hypertension.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Education Based on Pender Health Promotion Model. The content of perceived cessation of blood pressure control from valid sources is based on the Pender Health Promotion Model constructs and  Validated by 10 nursing and cardiologists.  In this group, educational intervention according to Pender model with routine care during 6 sessions of 45-60 minutes for 6 weeks in groups of 4 to 6 people with group discussion and question and answer in Shahid Beheshti Medical Center will be done.The center's routine training also includes the presentation of an educational pamphlet based on the Guideline on Blood Pressure Control in Iran. Intervention 2: Control group: Routine training in medical center. The routine training of the center includes the presentation of an educational pamphlet based on the Guideline on Blood Pressure Control in Iran.</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:
The total potential data can be shared after unidentifiable people

When:
Start the access period 6 months after printing the results

To whom:
Only available to scholars working in academia and academia.

Conditions:
If you observe the trust and mention the source, data is available for researchers.

Where to obtain:
Send the following e-mail to the following address:
taghadosi_m@kaums.ac.ir

How to obtain:
After receiving the letter via email, your request will be reviewed within 2 weeks and the data will be sent to the applicant at the discretion.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mohsen Taghadosi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Ravandi Ghotb Blvd</address>
        <city>Kashan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>87159/81151</zip>
        <telephone>+98 36 1555 0021</telephone>
        <email>taghadosi_m@kaums.ac.ir</email>
        <affiliation>Kashan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mohsen Taghadosi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Ravandi Ghotb Blvd</address>
        <city>Kashan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8715988141</zip>
        <telephone>+98 36 1555 0021</telephone>
        <email>taghadosi_m@kaums.ac.ir</email>
        <affiliation>Kashan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Being a citizen of Iranian and Persian languages
The ability to communicate verbally
Age 20 to 65 years old
Having a primary hypertension with cardiologist confirmed
At least 6 months have passed since the diagnosis of the disease
Patients who score questionnaire based on their adherence to treatment adherence is less than 86.
The lack of physical and mental debilitating diseases known for example, MR, depression and cancer
Location in Kashan
Along the patient is literate
The desire and informed consent to participate in the study</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Unwillingness to continue cooperation during the study
The absence of training sessions (more than one session)
Changes in the course of illness and patient's therapies so that the type of drug or dose of his medication changes.
Having a disease or complication that leads to hospitalization during the study, such as heart attacks, stroke, kidney failure, etc.</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: Education Based on Pender Health Promotion Model. The content of perceived cessation of blood pressure control from valid sources is based on the Pender Health Promotion Model constructs and  Validated by 10 nursing and cardiologists.  In this group, educational intervention according to Pender model with routine care during 6 sessions of 45-60 minutes for 6 weeks in groups of 4 to 6 people with group discussion and question and answer in Shahid Beheshti Medical Center will be done.The center's routine training also includes the presentation of an educational pamphlet based on the Guideline on Blood Pressure Control in Iran.</i_keyword>
      <i_keyword>Control group: Routine training in medical center. The routine training of the center includes the presentation of an educational pamphlet based on the Guideline on Blood Pressure Control in Iran.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Adherence to Treatment. Timepoint: Baseline, 1 and 2 months after completion of intervention. Method of measurement: treatment adherence questionnaire for patients with hypertension (TAQPH) Persian version.</prim_outcome>
      <prim_outcome>Blood pressure. Timepoint: Baseline, weeks 1, 3, 5 and 1and 2 month after the intervention. Method of measurement: In compliance with all standards of JNC 7 using a mercury manometer adults model F.BOSCH (GERMANY), which was calibrated with mercury healthy.</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>Kashan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-01-08</approval_date>
        <contact_name>Kashan University of Medical Sciences</contact_name>
        <contact_address>Ghotb Ravandi Blvd, Kashan Kashan Isfehan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
