<?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>IRCT20180726040606N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-01-05</date_registration>
      <primary_sponsor>Iran University of Medical Sciences</primary_sponsor>
      <public_title>The Effect of Pender’s Health Promotion Model on Life Style And Self Efficacy</public_title>
      <acronym></acronym>
      <scientific_title>The Effect of Pender’s Health Promotion Model on Life Style And Self Efficacy of Clients With Diabetic Foot</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-09-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>70</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/32894</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: In the process of selecting samples from a continuous method and Assignment of samples to the test and control group Blocked randomization method will be used. The researcher designed a 4-part package and Based on sample count, Possibilities of the test and control group in that package. The selection of samples from the test and control group is on the responsibility of the Nurses Which does not know the flow of the study. With her choice The distribution of samples is randomly assigned to the test and control group, Blinding description: This study will be done in two blind ways. As a researcher when collecting information, The presence of samples in the test and control group is not known. On the other hand, samples are also unaware of being in the test and control group. This method increases the power of study.</study_design>
      <phase>3</phase>
      <hc_freetext>Clients with Diabetic Foot.</hc_freetext>
      <i_freetext>Intervention 1: "Intervention group":  For this group by lecturing and giving booklets training was done. The main dimensions of Pender’s model as nutrition, exercise, responsibility about his health, stress management (Identify Stress Resources, Stress management actions), Interpersonal support( Maintaining relationships with proximity), self actualization(Having a sense of purpose, Looking for personal progress and Self-knowledge and satisfaction experience). In the lecture method, firstly the test group is in the clinic classroom, Training related to Pender Health Promotion Model, Using Whiteboard and Powerpoint (The educational sessions were 4 and each 2 hours which were held in 2 weeks). At the end of sessions the booklet was given to the samples.In the first and fourth sessions the HPLP 2 and self efficacy instrument for diabetic foot patients were completed. Every 15 days Questions will be asked by the researcher on the educational materials of the samples(Within 50 days after intervention, The researcher will call you three times). After 50 days, samples in the dates that the researcher co-ordinated with them, They go back to the treatment centers. The mentioned tools will be completed again by the intervention group. Intervention 2: "Control Group": In this group also completes the mentioned forms(HPLP 2 and self efficacy instrument for diabetic foot patients), Common trainings will be received by clinic staff before discharge. The group also returned to the clinic after 50 days, with previous coordination and The forms will be completed and Finally, the instruction book will be delivered to this group as well.</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:
I will share some of the data

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

To whom:
Researchers working in academia and academia

Conditions:
To improve self-efficacy and lifestyle of patients with diabetic foot ulcer

Where to obtain:
Perya Vakilian, Faculty of Nursing and Midwifery, Tehran, p.vakilian1395@gmail.comn

How to obtain:
Applying through the researcher's personal email from the supervisor

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Parya Vakilian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 1, 13 Ave., Asgari Street., North Shahran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1478738933</zip>
        <telephone>+98 21 4435 5764</telephone>
        <email>p.vakilian1395@gmail.com</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Alice Khachian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 5, 11 Ave., Asgari Street.,North Shahran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1478738944</zip>
        <telephone>+98 21 8888 2885</telephone>
        <email>alicekhachian@hotmail.com</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients with type 1 diabetes or 2 with medical diagnosis included in the case
Patients with diabetic foot ulcers
Literacy reading and writing
Aged 18 years and older
Unemployment or Graduate in Health Care
Ability to communicate
No history of diabetic foot scars</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Not attending even in a training session
Vascular Disease</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>E08</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Diabetes mellitus due to underlying condition</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Lifestyle</i_code>
      <i_code>Lifestyle</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>"Intervention group":  For this group by lecturing and giving booklets training was done. The main dimensions of Pender’s model as nutrition, exercise, responsibility about his health, stress management (Identify Stress Resources, Stress management actions), Interpersonal support( Maintaining relationships with proximity), self actualization(Having a sense of purpose, Looking for personal progress and Self-knowledge and satisfaction experience). In the lecture method, firstly the test group is in the clinic classroom, Training related to Pender Health Promotion Model, Using Whiteboard and Powerpoint (The educational sessions were 4 and each 2 hours which were held in 2 weeks). At the end of sessions the booklet was given to the samples.In the first and fourth sessions the HPLP 2 and self efficacy instrument for diabetic foot patients were completed. Every 15 days Questions will be asked by the researcher on the educational materials of the samples(Within 50 days after intervention, The researcher will call you three times). After 50 days, samples in the dates that the researcher co-ordinated with them, They go back to the treatment centers. The mentioned tools will be completed again by the intervention group.</i_keyword>
      <i_keyword>"Control Group": In this group also completes the mentioned forms(HPLP 2 and self efficacy instrument for diabetic foot patients), Common trainings will be received by clinic staff before discharge. The group also returned to the clinic after 50 days, with previous coordination and The forms will be completed and Finally, the instruction book will be delivered to this group as well.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Study of lifestyle in diabetic foot ulcers. Timepoint: The beginning of the study (before the intervention) and 50 days after the intervention. Method of measurement: Health Promoting Lifestyle Profile II.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Self-efficacy study in diabetic foot ulcers. Timepoint: The beginning of the study (before the intervention) and 50 days after the intervention. Method of measurement: Diabetic Foot Care Self Efficacy Scale.</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>Iran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-04-07</approval_date>
        <contact_name>Ethics Committee of Iran University of Medical Sciences</contact_name>
        <contact_address>No. 1, 13 Ave., Asgari Street., North Shahran Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
