<?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>IRCT20100811004548N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-02-02</date_registration>
      <primary_sponsor>Yazd University of Medical Sciences</primary_sponsor>
      <public_title>Thesis Title:	Investigating the effect of nurse -led telephone based follow-up on the participation rate of firstdegree relatives of elderly patients with glaucoma in screening program</public_title>
      <acronym></acronym>
      <scientific_title>Thesis Title:	Investigating the effect of nurse -led telephone based follow-up on the participation rate of firstdegree relatives of elderly patients with glaucoma in screening program</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-01-10</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>110</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/60769</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Screening, Randomization description: A list of the number of first-degree high-risk individuals in each family and their contact numbers are prepared in order of identification time until the sample size is completed, and first-degree members of the patient's family are assigned to one of the two intervention or control groups. To ensure the equality of the number of people in the two groups, the list is prepared using the method of quadruple random block blocks and with the guidance of a methodology consultant.</study_design>
      <phase>3</phase>
      <hc_freetext>Glaucoma.</hc_freetext>
      <i_freetext>Intervention group: First-degree relatives of an elderly person over 35 years of age with newly diagnosed glaucoma will be examined by telephone through a pre-arranged letter for three consecutive months.A telephone call is once a month during which a needs assessment is performed and information and education is given about glaucoma and its treatment and prevention..</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:
The results of the screening questionnaire of first-degree relatives of elderly patients with glaucoma will be statistically analyzed and reported after non-identification of individuals.

When:
The access period will start six months after the results are published.

To whom:
Access to the data of this study is free.

Conditions:
Studying the documents and using the questionnaire and data obtained from the study is free

Where to obtain:
Corresponding author:
Farahnaz Farnia, PhD; Research Center for Nursing and Midwifery Care, Nursing- Midwifery School of 
Shahid Sadoughi University, Boali St, Safaeeye, Postal code 8916877391, Yazd, Iran
Tel: +98 35 38245777; Fax: +98 351 8249705; Email: far.farnia@yahoo.com

How to obtain:
The applicant can receive the documents after sending the application by email and also by phone and coordination.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Seyd Aliasghar Mosavi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 57، Arasteh Alley، Manzarieh</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1914853185</zip>
        <telephone>+98 21 2260 5915</telephone>
        <email>a_a_mosavi@gmail.com</email>
        <affiliation>Semnan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Farahnaz Farnia</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Nursing and Midwifery، Bouali St، Commander Fallahi, Safaieh neighborhood</address>
        <city>yazd</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8916877391</zip>
        <telephone>+98 35 3824 1751</telephone>
        <email>far.farnia@yaho.com</email>
        <affiliation>Yazd University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>First-degree relatives (parents, children, siblings) of regular clients of  Mahde kramat Semnan Ophthalmology Clinic who have been diagnosed with glaucoma for the first time in the last three months
Elderly glaucoma has recently been confirmed by a clinic ophthalmologist
Be at least one first-degree family member 35 years of age or older
Have access to the telephone at home</inclusion_criteria>
      <agemin>35 years</agemin>
      <agemax>90 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Oblivion of a patient with glaucoma  and not remembering the phone number of any family member
Participation of the patient's family member in other studiesClinical glaucoma screening
Hearing and speech disorders cause problems for telephone interaction
Has a history of mental, intellectual, forgetfulness problems and treated with sedatives,Hypnotic and psychoactive</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>H40.05</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Ocular hypertension</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: First-degree relatives of an elderly person over 35 years of age with newly diagnosed glaucoma will be examined by telephone through a pre-arranged letter for three consecutive months.A telephone call is once a month during which a needs assessment is performed and information and education is given about glaucoma and its treatment and prevention.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Participate in the glaucoma screening test. Timepoint: Measurement  will be at the beginning of the study and three months later. Method of measurement: questionnaire.</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>Yazd University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-11-17</approval_date>
        <contact_name>Ethics Committee of Shahid Sadoughi University of Medical Sciences, Yazd</contact_name>
        <contact_address>Shahid Sadoughi University of Medical Sciences, Central Building, Shahid Bahonar Boulevard, Yazd Yazd Yazd Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
