<?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>IRCT20230522058256N1</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 implementing the Family Health Nurse Model on Self-management and Glycosylated Hemoglobin</public_title>
      <acronym></acronym>
      <scientific_title>Investigating the Effect of Implementing the Family Health Nurse Model on Self-management and Glycosylated Hemoglobin of Middle-aged Women with Type 2 Diabetes</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-08-08</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>84</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/70566</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Type 2 diabetes.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: For this group, the steps of the localized family health nurse model, which was developed by Kishori 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" It has been designed and will be implemented. This model will include three stages (before intervention, intervention, and evaluation). The pre-intervention stage included two preliminary stages and the first meeting with the samples, during the preliminary stage, the necessary measures were taken to meet the people with diabetes, and in the first meeting with the samples, after completing the relevant questionnaires, their initial evaluation in The home visit center and time will be coordinated with them. In the intervention stage, which includes (home visits, implementation in the center and provision of a localized family health model service package, formation of self-help groups, and follow-up for 3 months), at least during two home visit sessions and the selection of a family health ambassador, with Use the relevant forms to assess the educational needs of the family with the help of family members and after identifying the identified problems of the patient, based on the nursing diagnoses, plan nursing care for the affected person with the help of the family and a localized model package that includes (counseling Individual, educational booklet and holding training sessions, referral to the doctor, follow-up of internal referrals made by the doctor (to a psychiatrist, nutritionist, internal specialist) and follow-up of external referrals) will be provided according to the needs and problems of each patient. Then, for 3 months, in the form of self-help group meetings and monthly care, and fasting blood sugar control, he will follow up with the affected people. The evaluation stage of this model will be done in 3 stages (during the intervention, immediately after the intervention, and 3 months after the intervention by diabetes self-management questionnaire and glycosylated hemoglobin test). Intervention 2: Control group:Control group: In this study, the control group after being called to the center, performing the initial assessment, glycosylated hemoglobin test, and completing the relevant questionnaires, will be referred to the health care providers and will receive the center's routine care for 3 months, and after 3 months, the questionnaires will be re-administered. Completion and testing of their glycosylated hemoglobin will be done.</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>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is There is no further information.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Tayebeh Karimi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Hazar Jarib St., Isfahan University of Medical Sciences and Health Services, Nursing and Midwifery College</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8174673461</zip>
        <telephone>+98 31 3668 7153</telephone>
        <email>tkarimi@nm.mui.ac.ir</email>
        <affiliation>Esfahan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Tayyaba Karimi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Hazar Jarib St., Isfahan University of Medical Sciences and Health Services, Nursing and Midwifery College</address>
        <city>Esfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8174673461</zip>
        <telephone>+98 31 3668 7153</telephone>
        <email>tkarimi@nm.mui.ac.ir</email>
        <affiliation>Esfahan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Have an active file in the center
At least one year has passed since the diagnosis of their disease
There should be no restrictions on entering the house and visiting the house.
HbA1C should be considered uncontrolled according to the patient's medical record and the doctor's opinion
Willingness and informed consent to participate in the research
Have Iranian nationality</inclusion_criteria>
      <agemin>30 years</agemin>
      <agemax>59 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Suffering from chronic and advanced complications of diabetes such as nephropathy, proliferative retinopathy, amputation
Suffering from cognitive problems including mental retardation or known psychological disorders
Failure to complete HBA1c questionnaires and tests or their incomplete completion</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>E11.00</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Type 2 diabetes mellitus with hyperosmolarity without nonketotic hyperglycemic-hyperosmolar coma (NKHHC)</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: For this group, the steps of the localized family health nurse model, which was developed by Kishori 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" It has been designed and will be implemented. This model will include three stages (before intervention, intervention, and evaluation). The pre-intervention stage included two preliminary stages and the first meeting with the samples, during the preliminary stage, the necessary measures were taken to meet the people with diabetes, and in the first meeting with the samples, after completing the relevant questionnaires, their initial evaluation in The home visit center and time will be coordinated with them. In the intervention stage, which includes (home visits, implementation in the center and provision of a localized family health model service package, formation of self-help groups, and follow-up for 3 months), at least during two home visit sessions and the selection of a family health ambassador, with Use the relevant forms to assess the educational needs of the family with the help of family members and after identifying the identified problems of the patient, based on the nursing diagnoses, plan nursing care for the affected person with the help of the family and a localized model package that includes (counseling Individual, educational booklet and holding training sessions, referral to the doctor, follow-up of internal referrals made by the doctor (to a psychiatrist, nutritionist, internal specialist) and follow-up of external referrals) will be provided according to the needs and problems of each patient. Then, for 3 months, in the form of self-help group meetings and monthly care, and fasting blood sugar control, he will follow up with the affected people. The evaluation stage of this model will be done in 3 stages (during the intervention, immediately after the intervention, and 3 months after the intervention by diabetes self-management questionnaire and glycosylated hemoglobin test).</i_keyword>
      <i_keyword>Control group:Control group: In this study, the control group after being called to the center, performing the initial assessment, glycosylated hemoglobin test, and completing the relevant questionnaires, will be referred to the health care providers and will receive the center's routine care for 3 months, and after 3 months, the questionnaires will be re-administered. Completion and testing of their glycosylated hemoglobin will be done</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Diabetes self-management score in the Schmitt diabetes self-management questionnaire. Timepoint: Before, immediately and 3 months after the intervention. Method of measurement: Diabetes Self-Management Questionnaire.</prim_outcome>
      <prim_outcome>The percentage of people who have glycosylated hemoglobin above 7.7. Timepoint: Before and 3 months after the intervention. Method of measurement: Glycosylated hemoglobin blood test.</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>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>Ethical Committee of Isfahan University of Medical Sciences</contact_name>
        <contact_address>Hazar Jarib Street, Isfahan University of Medical Sciences, School of Nursing and Midwifery Esfahan Isfehan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
