<?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>IRCT2014031516997N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2014-05-17</date_registration>
      <primary_sponsor>Tehran University of Medical Sciences</primary_sponsor>
      <public_title>The effect of an education program with telephone follow-up on the health behaviors of elderly patients with hypertension</public_title>
      <acronym></acronym>
      <scientific_title>Effect of Tele-nursing-based empowerment program on self-efficacy in the elderly with hypertension</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2014-05-06</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>84</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/15752</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Other.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Hypertension.</hc_freetext>
      <i_freetext>Intervention 1: To implement empowerment program, an educational session will be provided in the form of speeches, group discussion and questions and answers (educational workshop) for both trial and control groups. The workshop will be a 2-hour session in a day for patients with hypertension. Prior to selection of subjects, patients will complete pretest questionnaire in presence of the researcher (before intervention). Then, educational subjects about nature of hypertension, complications and control methods, principles of medication therapy, medication side-effects, reinforcement of appropriate behavior in disease control and stress management, DASH diet, and appropriate exercise for hypertension are provided. It should be noted that educational subjects are presented over 50 minutes with 15 minutes rest in the middle, and educational booklets containing the subjects discussed will be issued to participants by the end of the session. Afterwards, telephone intervention will be conducted for the trial group over 12 weeks. Twice weekly telephone contacts will be made to trial group members in the first month, and once a week in the 2nd and 3rd months. Timing of calls is agreed between the researcher and the elderly, any time between 8 am and 2 pm, and each telephone conversation will last 15 minutes on average. Study subjects can call the researcher between 8 am and 2 pm if necessary. In the first part, telephone conversations will focus on verbal encouragement for health behaviors in the elderly regarding educational workshop subjects, and the second part will be based on particular requirements of each elderly in relation to hypertension self-care, and while health behaviors are encouraged, necessary advice is also provided. Content of every conversation is recorded on a form. Intervention 2: In the course of study, control group does not receive any kind of tele-nursing intervention (except receiving empowerment programs in educational workshops and routine medicinal treatment).</i_freetext>
      <results_actual_enrolment></results_actual_enrolment>
      <results_date_completed></results_date_completed>
      <results_url_link> http://unmf.umsu.ac.ir/browse.php?a_code=A-10-1693-1&amp;slc_lang=fa&amp;sid=1</results_url_link>
      <results_summary>     Background and Aim: Hypertension, with high prevalence in the elderly, is one of the most important and the most common chronic disease that require to self-care behaviors in patients. The purpose of this study was to determine the impact of the empowerment program based on the Telephone Follow-up (Tele-nurses) on Self Care Self efficacy in elderly patients with hypertension.&lt;br /&gt;&#13;
Materials and Methods: This quasi-experimental study on 88 elderly patients with hypertension was admitted to the outpatient clinic of the Sayyad Shirazi Hospital in Gorgan. The subjects was selected by sequential sampling method and divided to the experimental (n=44) and control (n=44) groups. Data were collected through a questionnaire. All the subjects in the experimental and control groups were participated in the self-care workshops. However, the experimental group received telephone counseling and follow-up intervention for 12 weeks. Data was analyzed using SPSS-16 Software and descriptive and inferential statistical.&lt;br /&gt;&#13;
Results: The study findings showed that there were no significant differences between the two groups in terms of demographic and disease-related variables. The means and standard deviations on the scores Self - Efficacy in self-care behaviors pre –post intervention were [3.5 (SD=0.4) &amp; 4.1(SD=0.3)] in the experimental and [3.4 (SD=0.3) &amp; 3.6 (SD=0.3)] control groups respectively. There was no significant difference between the groups regarding the mean scores of Self - Efficacy in self-care behaviors on before intervention (P=0.44). Whereas, at post-intervention, the elderly patients with hypertension participating in the empowerment program (workshop and telephone follow up) group showed statistically significant increases in self-efficacy (p≤ 0.05) compared with the control group.&lt;br /&gt;&#13;
Conclusion: The findings of the present study showed that empowerment program based on tele-nursing care was effective in promoting the Self - Efficacy in self-care behaviors of elderly patients with hypertension. Thus, the important role of tele-nursing in promoting Self - Efficacy in self-care behaviors in this group of the elderly was emphasized and confirmed. &lt;br /&gt;&#13;
&lt;br /&gt;&#13;
Key words: Self -efficacy, Tele-Nursing, Self- care, Older Adults, Hypertension.  &lt;br /&gt;&#13;
      </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></results_IPD_plan>
      <results_IPD_description></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Yosof Behzad</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Tehran School of Nursing and Midwifery,  Touhid Square, Tehran, Iran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1419733171</zip>
        <telephone>+98 21 6692 7171</telephone>
        <email>behzadyosof@gmail.com</email>
        <affiliation>School of Nursing and Midwifery, Tehran</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Faride Bastani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Rashid Yasemi St., Vanak Sq., Valiasr St., Tehran, Iran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1996713883</zip>
        <telephone>+98 21 8888 2885</telephone>
        <email>faridehbastani@yahoo.com</email>
        <affiliation>School of Nursing and Midwifery, Iran</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: aged between 65 and 80 years; living in Golestan province; access to telephone at home; having no dementia or cognitive impairments; no hearing or speech problems or mental disorders; no hypothyroidism or diabetes&#13;
Exclusion criteria: death; unwillingness to continue participation; discontinued telephone contact for 2 weeks in the first month of intervention; or 3 weeks in the 2nd and 3rd.</inclusion_criteria>
      <agemin>65 years</agemin>
      <agemax>80 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>110</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>High blood pressure</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Other</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>To implement empowerment program, an educational session will be provided in the form of speeches, group discussion and questions and answers (educational workshop) for both trial and control groups. The workshop will be a 2-hour session in a day for patients with hypertension. Prior to selection of subjects, patients will complete pretest questionnaire in presence of the researcher (before intervention). Then, educational subjects about nature of hypertension, complications and control methods, principles of medication therapy, medication side-effects, reinforcement of appropriate behavior in disease control and stress management, DASH diet, and appropriate exercise for hypertension are provided. It should be noted that educational subjects are presented over 50 minutes with 15 minutes rest in the middle, and educational booklets containing the subjects discussed will be issued to participants by the end of the session. Afterwards, telephone intervention will be conducted for the trial group over 12 weeks. Twice weekly telephone contacts will be made to trial group members in the first month, and once a week in the 2nd and 3rd months. Timing of calls is agreed between the researcher and the elderly, any time between 8 am and 2 pm, and each telephone conversation will last 15 minutes on average. Study subjects can call the researcher between 8 am and 2 pm if necessary. In the first part, telephone conversations will focus on verbal encouragement for health behaviors in the elderly regarding educational workshop subjects, and the second part will be based on particular requirements of each elderly in relation to hypertension self-care, and while health behaviors are encouraged, necessary advice is also provided. Content of every conversation is recorded on a form.</i_keyword>
      <i_keyword>In the course of study, control group does not receive any kind of tele-nursing intervention (except receiving empowerment programs in educational workshops and routine medicinal treatment).</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Self Efficacy. Timepoint: Before and after the intervention will be measured. Method of measurement: Efficacy Questionnaire in patients with hypertension with appropriate validation.</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>Tehran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2014-04-16</approval_date>
        <contact_name>Tehran University of Medical Sciences</contact_name>
        <contact_address>Tehran University of Medical Sciences, Tehran, Iran Tehran  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
