<?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>IRCT20190806044449N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-07-23</date_registration>
      <primary_sponsor>Esfahan University of Medical Sciences</primary_sponsor>
      <public_title>Investigating the effect of implementing the family health nurse model on Hypertension self-management</public_title>
      <acronym></acronym>
      <scientific_title>Investigating the effect of the implementation of the family health nurse model on self-management of high blood pressure in the elderly</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-08-08</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>76</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/71269</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Randomization will be done in two stages. At first, referring to Isfahan Health Network 1, a center will be selected as the intervention group by lottery, and then, for the control group to be homogeneous with the subjects of the intervention center in terms of social and economic conditions, one center will be selected as the control group by lottery among the comprehensive health service centers that are located in the vicinity of the center of the intervention group. In the second stage, in the centers selected by the researcher, through the Sib system, the head of the center will prepare a list of all the people who meet the entry criteria and systematically select the subjects, in such a way that the total number of the research population is divided by the required number of subjects to get the K number. Then randomly, the first number below ten is obtained, which is called n. Then the numbers N+K, N+2K, N+3K,... will be selected until the last subject.</study_design>
      <phase>N/A</phase>
      <hc_freetext>hypertension.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Intervention group: For this group, the steps of the localized family health nurse model, which was developed 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" 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 high blood pressure, and in the first meeting with the samples, after completing the relevant questionnaires, an initial assessment was carried out. They will be done at the center and the home visit 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 nursing diagnoses, nursing care for the affected person is planned with the help of the family and a localized model package that includes individual counseling. , educational booklets and holding training sessions, referral to a doctor, follow-up of internal referrals made by a doctor to a psychiatrist, nutritionist, or specialist doctor, 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 holding self-help group meetings and conducting monthly care and blood pressure control, he will follow up with the affected people. The evaluation stage of this model will also be done during 3 stages (during the intervention, immediately after the intervention, and 3 months after the intervention) by means of the Stafford Chronic Disease Self-Management Questionnaire and blood pressure measurement. Intervention 2: Control group: In this study, the control group after being called to the center, performing initial assessment, measuring blood pressure, and completing relevant questionnaires referred to health care providers and receive routine care at the center for 3 months, and after 3 months they complete the questionnaires and Their blood pressure 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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
Results from demographic data, questionnaires and blood tests can be shared anonymously. The study protocol will be announced.

When:
Start access period after printing results

To whom:
According to the research title, all interested people will have access to the results.

Conditions:
The results will be published in scientific journals and in addition ; the researchers' emails will be available

Where to obtain:
he way to communicate is emails:
shahshahani@nm.mui.ac.ir 
zohreh.noorollahi@gmail.com

How to obtain:
It will be answered at least 1 week after request.

Comments:
Only the results and study protocol will be presented.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Zohreh Noorollahi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Department of Community Health, School of Nursing and Midwifery, Isfahan University of Medical Sciences, Hezar Jerib Street, Azadi Square, Isfahan, Iran</address>
        <city>Esfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8174673461</zip>
        <telephone>+98 31 3668 7153</telephone>
        <email>Zohreh.noorollahi@gmail.com</email>
        <affiliation>Esfahan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Maryam Sadat Shahshahani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Nursing and Midwifery, Isfahan University of Medical Sciences, Hezar Jerib Street, Isfahan, Iran</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8174673461</zip>
        <telephone>+98 31 3668 7153</telephone>
        <email>shahshahani@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>Elderly aged 60-74 years
Willingness to participate in the study
Patients with high blood pressure above 140/90
Living in Isfahan city
Diagnosis of high blood pressure for at least 6 months
Not suffering from mental disorders
Farsi speaking participants
Doing daily activities independently
The presence of an active person in the elderly home (family health ambassador based on ambassador criteria)</inclusion_criteria>
      <agemin>60 years</agemin>
      <agemax>74 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Having chronic diabetes that leads to cardiovascular disorders.
Having untreated hypothyroidism</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>I10</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Essential (primary) hypertension</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: Intervention group: For this group, the steps of the localized family health nurse model, which was developed 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" 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 high blood pressure, and in the first meeting with the samples, after completing the relevant questionnaires, an initial assessment was carried out. They will be done at the center and the home visit 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 nursing diagnoses, nursing care for the affected person is planned with the help of the family and a localized model package that includes individual counseling. , educational booklets and holding training sessions, referral to a doctor, follow-up of internal referrals made by a doctor to a psychiatrist, nutritionist, or specialist doctor, 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 holding self-help group meetings and conducting monthly care and blood pressure control, he will follow up with the affected people. The evaluation stage of this model will also be done during 3 stages (during the intervention, immediately after the intervention, and 3 months after the intervention) by means of the Stafford Chronic Disease Self-Management Questionnaire and blood pressure measurement.</i_keyword>
      <i_keyword>Control group: In this study, the control group after being called to the center, performing initial assessment, measuring blood pressure, and completing relevant questionnaires referred to health care providers and receive routine care at the center for 3 months, and after 3 months they complete the questionnaires and Their blood pressure will be measured again.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>High blood pressure self-management score in the Stanford Self-Management Questionnaire. Timepoint: Before, immediately and 3 months after the intervention. Method of measurement: Stanford chronic disease self-management questionnaire.</prim_outcome>
      <prim_outcome>Hypertension. Timepoint: Before, immediately and 3 months after the intervention. Method of measurement: Mercury sphygmomanometer.</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>School of Nursing and Midwifery, Isfahan University of Medical Sciences, Hezar Jerib Ave., Azadi Square Esfahan Isfehan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
