<?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>IRCT20180519039710N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-07-29</date_registration>
      <primary_sponsor>Mashhad University of Medical Sciences</primary_sponsor>
      <public_title>Cost-effectiveness of peer education on treatment adherence among elderly hypertensive client</public_title>
      <acronym></acronym>
      <scientific_title>Cost-effectiveness of peer education on treatment adherence among elderly hypertensive client</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-08-01</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>50</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/31597</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Assigned with random spss numbers, in intervention or control groups, randomly, Blinding description: Elderly people with Hypertension Grade 2 and above who take anti-hypertensive medications for 6 months are randomly divided into intervention and control groups. While they are in the group, they do not know.</study_design>
      <phase>N/A</phase>
      <hc_freetext>treatment adherence among Elderly Hypertensive client.</hc_freetext>
      <i_freetext>Intervention group: first, an elderly person with hypertension who has controlled his or her blood pressure in the last six months, means that there is no systolic pressure greater than 16 years old and has a specific problem associated with hypertension or hospitalization due to HTN. Selected as a peer. Then, 3 sessions of 45 minutes, with the contents of the standard educational package, are communicated by the Ministry of Health regarding the control of blood pressure and its importance in reducing costs. In the intervention group, 45-minute training sessions with standard educational package content are provided by peer group for other elderly once a week for 6 weeks..</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:
Evaluating the Effectiveness of Peer Education on Adherence to Treatment of Elderly With Hypertension, Compared to Routine Training

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

To whom:
Researchers and  patients with hypertension

Conditions:
After collecting data and encoding and logging into the computer, using spss 11 software, data analysis is done using descriptive and inferential statistics. To describe the characteristics of the research units in the two groups, descriptive statistics including frequency distribution and percentages, and central inclination and dispersion, mean, and standard deviations are used. In the analytical statistics, a quantitative data test was performed using Kolmogorov-Smynov and Shapiro Wilk tests. To determine the homogeneity of data in two groups, Chi-square or Fisher test for qualitative variables and independent t-test for quantitative variables and if the abnormality is used, the Mann-Whitney test will be used. Also, intra-group comparisons based on whether data are normal or not, paired t-test or Kruskal-Wallis tests will be used. To determine the relationship between the underlying and interventional variables, two groups of variance analysis or covariance analysis will be used in three groups. To compare the cost-effectiveness of the two methods of peer-to-peer training, with the help of a statistic expert, Tree Age's decision tree model and software will be used. For all tests, the confidence coefficient will be 95%

Where to obtain:
Faculty of Nursing and Midwifery, Ibn Sina Avenue,Doktora st.Mashhad, Iran   Phone:0098 5138591511   Fax: 0098 5138597313   Zip Code: 9137913199   E-mail: NMS.IT@mums.ac.ir

How to obtain:
Referring to the library of Mashhad Nursing and Midwifery Faculty and presenting the identification card to this unit and receiving the existing documentation

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Kobra Sadeghi vazin</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Nursing and Midwifery,Ebne Sina Ave.,Doktora Intersection, Mashhad, Iran</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9166987</zip>
        <telephone>+98 51 3841 2810</telephone>
        <email>sadeghivk951@mums.ac.ir</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Kobra Sadeghi Vazin</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Nursing and Midwifery, Ebne Sina Ave., Doktora Intersection, Mashhad, Iran</address>
        <city>Mashhaf</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9166987</zip>
        <telephone>+98 51 3841 2810</telephone>
        <email>sadeghivk951@mums.ac.ir</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>The desire to participate in the study
History of at least 6 months of hypertension
GRID 2 and higher hypertension
Lack of Cyrus hypertension
Age 60 and older
Ability to speak Persian
Literacy reading and writing
Treated with anti hypertensive drugs
Iranian and resident of Mashhad
Lack of physical and cognitive disorder preventing intervention
Lack of training in hypertension education over the past 6 months</inclusion_criteria>
      <agemin>60 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Missing more than 1 session at training sessions
Deaths of research units
Acute illness or hospitalization
Unwillingness to cooperate or refuse to attend training sessions</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>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: first, an elderly person with hypertension who has controlled his or her blood pressure in the last six months, means that there is no systolic pressure greater than 16 years old and has a specific problem associated with hypertension or hospitalization due to HTN. Selected as a peer. Then, 3 sessions of 45 minutes, with the contents of the standard educational package, are communicated by the Ministry of Health regarding the control of blood pressure and its importance in reducing costs. In the intervention group, 45-minute training sessions with standard educational package content are provided by peer group for other elderly once a week for 6 weeks.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Cost-effectiveness of peer education. Timepoint: three month after intervention. Method of measurement: Measuring Adherence to treatment using the Murisky scale.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Adherence to drug treatment. Timepoint: Before intervention, end of intervention, three and six weeks after the end intervention. Method of measurement: Murisky eight-questions questionnaire related to adherence to drug treatment.</sec_outcome>
      <sec_outcome>Adherence to diet treatment. Timepoint: Before intervention, end of intervention, three and six weeks after the end intervention. Method of measurement: Researchers' made ten-questions questionnaire related to adherence to diet treatment.</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>Mashhad University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-06-30</approval_date>
        <contact_name>Regional Research Ethics Committee Mashhad University of Medical Sciences</contact_name>
        <contact_address>Department of Medical-Surgical Nursing, Nursing and Midwifery Faculty, Doctra Crossroad, Daneshgah Street, Mashhad, Iran Mashhad Razavi Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
