<?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>IRCT20230516058206N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-07-26</date_registration>
      <primary_sponsor>Esfahan University of Medical Sciences</primary_sponsor>
      <public_title>Investigating the effect of the family health nurse model on glycemic and anthropometric indicators</public_title>
      <acronym></acronym>
      <scientific_title>The survey on the effect of implementing an intervention based on the family health nurse model on glycemic and anthropometric indicators in middle-aged people with pre-diabetes</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-08-08</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>72</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/70176</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention.</study_design>
      <phase>N/A</phase>
      <hc_freetext>prediabetes.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: For this group, the steps of the localized family health nurse model, which was designed by Keshvari et al. in 2013 under the title "Explaining the process of providing health services to families covered by rural health centers in Isfahan city: Designing a suitable model for providing family health care", will be implemented. This model will include three stages (pre-intervention, intervention, evaluation). The pre-intervention stage includes two preliminary stages and the first meeting with the samples, during the preliminary stage, the necessary measures will be taken to meet the people with pre-diabetes and in the first meeting with the samples, after completing the relevant questionnaires, their initial assessment will be done at the center and the time of the home visit will be coordinated with them. In the intervention stage, which includes (home visit, implementation at the center and presentation of the service package of the localized family health model, formation of self-help groups and follow-up for 3 months), during at least two home visit sessions and the selection of a family health ambassador, using the relevant forms to assess the family's educational needs with the help of family members, and after identifying the identified problems of the patient, based on the nursing diagnoses, planning nursing care for the affected person with the help of the family, and the localized model package, which includes individual counselling, training booklets and holding training sessions, is referred to The doctor will follow up the internal referrals made by the doctor to the psychiatrist, nutritionist, specialist doctor and follow up the external referrals according to the needs and problems of each patient. Then, for 3 months, in the form of holding self-help group meetings and conducting monthly care and blood sugar control, he will follow up the affected people. The evaluation stage of this model will also be done during 3 stages (during the intervention, immediately after the intervention, 3 months after the intervention) by measuring blood sugar. Intervention 2: Control group: In this study, the control group after being called to the center, performing an initial assessment, measuring blood sugar and completing related questionnaires, were referred to health care providers and received routine care at the center for 3 months, including monthly follow-up and fasting blood sugar checks. They will receive referrals to nutrition and psychological experts, and after 3 months, the questionnaires will be completed again and their blood sugar will be measured again.</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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is no more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mohammad Azadmanesh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Isfahan Province, Isfahan, Hazarjarib St., Isfahan University of Medical Sciences, Faculty of Nursing and Midwifery</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8174673461</zip>
        <telephone>+98 911 410 8703</telephone>
        <email>m.azadmanesh19@gmail.com</email>
        <affiliation>Esfahan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Atefe Afshari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Isfahan Province, Isfahan, Hazarjarib St., Isfahan University of Medical Sciences, Faculty of Nursing and Midwifery</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8174673461</zip>
        <telephone>+98 913 222 7796</telephone>
        <email>afshar.atefe@yahoo.com</email>
        <affiliation>Esfahan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>For the client, the diagnosis of pre-diabetes has been registered in the Sib system by the doctor of the center in the last one-month through the Hba1c test.
Have the desire and informed consent to participate in the research.
Having consent for home visit.
Farsi speaking.
Be between the ages of 30 and 59.
Have minimum reading and writing literacy.</inclusion_criteria>
      <agemin>30 years</agemin>
      <agemax>59 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Reluctance to continue cooperation
Not completing the questionnaire or completing it incompletely
Disease progression to diabetes
Death of the patient or caregiver or causing problems in such a way that the patient and caregiver are unable to continue participating in the study.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>R73.01</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Impaired fasting glucose</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: For this group, the steps of the localized family health nurse model, which was designed by Keshvari et al. in 2013 under the title "Explaining the process of providing health services to families covered by rural health centers in Isfahan city: Designing a suitable model for providing family health care", will be implemented. This model will include three stages (pre-intervention, intervention, evaluation). The pre-intervention stage includes two preliminary stages and the first meeting with the samples, during the preliminary stage, the necessary measures will be taken to meet the people with pre-diabetes and in the first meeting with the samples, after completing the relevant questionnaires, their initial assessment will be done at the center and the time of the home visit will be coordinated with them. In the intervention stage, which includes (home visit, implementation at the center and presentation of the service package of the localized family health model, formation of self-help groups and follow-up for 3 months), during at least two home visit sessions and the selection of a family health ambassador, using the relevant forms to assess the family's educational needs with the help of family members, and after identifying the identified problems of the patient, based on the nursing diagnoses, planning nursing care for the affected person with the help of the family, and the localized model package, which includes individual counselling, training booklets and holding training sessions, is referred to The doctor will follow up the internal referrals made by the doctor to the psychiatrist, nutritionist, specialist doctor and follow up the external referrals according to the needs and problems of each patient. Then, for 3 months, in the form of holding self-help group meetings and conducting monthly care and blood sugar control, he will follow up the affected people. The evaluation stage of this model will also be done during 3 stages (during the intervention, immediately after the intervention, 3 months after the intervention) by measuring blood sugar.</i_keyword>
      <i_keyword>Control group: In this study, the control group after being called to the center, performing an initial assessment, measuring blood sugar and completing related questionnaires, were referred to health care providers and received routine care at the center for 3 months, including monthly follow-up and fasting blood sugar checks. They will receive referrals to nutrition and psychological experts, and after 3 months, the questionnaires will be completed again and their blood sugar will be measured again.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>HbA1c. Timepoint: At the beginning of the study and after the end of the intervention and 3 months after the end of the intervention. Method of measurement: HbA1c test.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Anthropometric indexes. Timepoint: Begin, at the end of intervention, 3 months after intervention. Method of measurement: meter.</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>Esfahan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-07-08</approval_date>
        <contact_name>Research Ethics Committees of Nursing, Rehabilitation and Management schools- Isfahan University of </contact_name>
        <contact_address>Hezar Jerib street, Isfahan, Iran isfahan Isfehan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
