<?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>IRCT2016061728502N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2016-09-09</date_registration>
      <primary_sponsor>Babol University of Medical Sciences</primary_sponsor>
      <public_title>The effect of family-centered empowerment model on elderlies with diabetes who are at falling risk in Bojnourd city</public_title>
      <acronym></acronym>
      <scientific_title>Determination the effect of family-centered empowerment model on elderlies with diabetes who are at falling risk in Bojnourd city</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2016-08-05</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/23114</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention.</study_design>
      <phase>N/A</phase>
      <hc_freetext>diabet.</hc_freetext>
      <i_freetext>Intervention 1: For groups, family-centered empowerment model based on the four-step threat perceived self-efficacy, educational participation and evaluation should be. Intervention 2: For routine care control group and a training session was conducted.</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></results_IPD_plan>
      <results_IPD_description></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Sakine Parvareshan</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Bojnurd, Takhti stadum, Kalate Av 1/2, NO12</address>
        <city>Bojnurd</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 58 3272 2145</telephone>
        <email>afsane_parvareshan@yahoo.com</email>
        <affiliation>North Khorasan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Abbas Shamsalinia</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Ramsar School of Nursing and Midwifery Fatemeh,  Zahra</address>
        <city>Ramsar</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>47745-47176</zip>
        <telephone>+98 11 5522 5151</telephone>
        <email>abbasshamsalinia@yahoo.com</email>
        <affiliation>Babol University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>elderly Inclusion criteria: Willingness to participate in research;60 years old elderly and older, The definitive diagnosis of type 2 diabetes with at least six months experience (tested and approved according to the doctor);having a case in related doctor's office; without having hearing and cognitive disorders based on AMT scale; reading and writing ability, Living with a family and residents of the city; Willing and able to make phone calls to elderly and active family members; Without having debilitating complications of diabetes such as blindness, low vision, joint disease (arthritis, Rheumatoid arthritis);Completing screening questionnaire of falling and earning score of 7 or higher; Inclusion criteria of patients' families: active Family members who want to participate in its research and collaboration; reading and writing ability of active members (a family member; wife or husband, Daughter or a relative or close relative), A person who has the constant care of the elderly and elderly is comfortable with him, Exclusion criteria for this study: Unwillingness to continuing the corporate (the patient with family) in the empowerment program and Completing research tools, Nervous system such as Parkinson's disease and paralysis defects and musculoskeletal disorders of the patient, passing Diabetes Education courses by the patient and family</inclusion_criteria>
      <agemin>60 years</agemin>
      <agemax>90 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>E11</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Non-insulin-dependent diabetes mellitus</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>For groups, family-centered empowerment model based on the four-step threat perceived self-efficacy, educational participation and evaluation should be</i_keyword>
      <i_keyword>For routine care control group and a training session was conducted.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Fall. Timepoint: 1 month. Method of measurement: Screening Questionnaire fall.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Family-centered empowerment aspects, including the perceived threat (perceived severity, perceived susceptibility), problem solving, educational participation and evaluation methods. Timepoint: Before the intervention, the empowerment questionnaire has been given . Then, for 1.5 months empowerment model has been done in 8 sessions of 45 minutes. One week and three months after the empowerment program, the questionnaire will be given again. Method of measurement: questionnaire of family-centered empowerment.</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>Babol University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2016-06-18</approval_date>
        <contact_name>Babol University of Medical Sciences</contact_name>
        <contact_address>-Babol University of Medical Sciences, Gangafrooz Street,  Babol Babol  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
