<?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>IRCT20220216054044N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-03-10</date_registration>
      <primary_sponsor>Tehran University of Medical Sciences</primary_sponsor>
      <public_title>The impact of a health care-based care program based on health expectation in  low vision patients with diabetes</public_title>
      <acronym></acronym>
      <scientific_title>Designing And Implementation Of The Caring Program Based On  Health Expectation In Low Vision Patients With Diabetes: A Mixed Method Study</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-04-09</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>48</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/62015</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Health service research, Other design features: The care plan is designed based on the health expectation of these patients and then implemented, Randomization description: Simple randomization method and use of patient code from hospitalization file. After introducing herself and the purpose of the study, the researcher examined the individual's desire to participate in the study and obtain informed written and oral consent, selected samples from the research community as available and randomly using a patient code in one of the two The group will intervene and control. The method of randomization is such that if the patient code is even, the patient will be in the intervention group and if it is an Odd in the control group.</study_design>
      <phase>N/A</phase>
      <hc_freetext>diabetes mellitus and low vision.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Receive self-care training in 4 sessions per week. They also receive nursing care based on the individual's needs in accordance with the principles of ethical values. Access to vital sign control and blood sugar control equipment is provided by the hospital to the researcher and samples, and access to hospital well-being is facilitated for the patient and his companion. In this study, patients in need of financial support are introduced to a social worker in coordination with the hospital. Intervention 2: Control group: Receive routine care. Routine care includes nursing care and self-care training in postoperative eye care provided by hospital nurses.</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:
Publication will be through articles and dissertations.

When:
From the end of June 1401

To whom:
University researchers

Conditions:
For training and judging

Where to obtain:
corresponding author

How to obtain:
After receiving the request, the request will be sent to the supervisor and if she agrees, the documents will be sent.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mahnaz Atapour</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Unit 9, 6th floor, East Almas Tower A, behind the metro station, El Goli Square, Tabriz, Iran</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>516868714</zip>
        <telephone>+98 41 3389 1084</telephone>
        <email>m-atapour@razi.tums.ac.ir</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Shahrzad Ghiyasvandian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Nursing and Midwifery, Tehran University of Medical Sciences, Dr. Mirkhani St. (Nosrat Sharghi), Tohid Square, Tehran, Iran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1419733171</zip>
        <telephone>+98 21 6105 4000</telephone>
        <email>shghiyas@tums.ac.ir</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Having type 1 or 2 diabetes, which is declared by the patient himself and the patient's tests and medical record also confirm this.
Hospitalization in eye surgery wards
Being 18 to 75 years old
Existence of ocular complications due to diabetes such as cataracts, glaucoma and retinopathy with the approval of the relevant physician and can be obtained from the patient's history from the file.
Visual impairment and reduction with visual acuity less than 6/12 or 10/5
Absence of cognitive, psychological and other problems related to mental processes
Having the ability to communicate and no hearing problems
No history of diseases other than diabetes that affect vision.
No history of taking drugs that affect a person's vision, which does not include the use of drugs that lower blood sugar.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>75 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Having type 1 or 2 diabetes, which is declared by the patient himself and the patient's tests and medical record also confirm this.
Hospitalization in eye surgery wards
Being 18 to 75 years old
Existence of ocular complications due to diabetes such as cataracts, glaucoma and retinopathy with the approval of the relevant physician and can be obtained from the patient's history from the file.
Visual impairment and reduction with visual acuity less than 6/12 or 10/5
Absence of cognitive, psychological and other problems related to mental processes
Having the ability to communicate and no hearing problems
No history of diseases other than diabetes that affect vision.
No history of taking drugs that affect a person's visio</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>E08.3</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Diabetes mellitus due to underlying condition with ophthalmic complications</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: Receive self-care training in 4 sessions per week. They also receive nursing care based on the individual's needs in accordance with the principles of ethical values. Access to vital sign control and blood sugar control equipment is provided by the hospital to the researcher and samples, and access to hospital well-being is facilitated for the patient and his companion. In this study, patients in need of financial support are introduced to a social worker in coordination with the hospital.</i_keyword>
      <i_keyword>Control group: Receive routine care. Routine care includes nursing care and self-care training in postoperative eye care provided by hospital nurses.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Self Care using with Summary of Diabetes Self Care Activities. Timepoint: Beginning of the study, 2 weeks after the end of the intervention, 1 month after the end of the intervention. Method of measurement: Self-care of patients with low vision due to diabetes is assessed using a Summary of Diabetes Self Care Activities questionnaire. This questionnaire developed by Tobert et al. (2000) examines a person's self-care activities over the past 7 days.</prim_outcome>
      <prim_outcome>General Health with using General Health Questionnaire. Timepoint: It is evaluated at the beginning of the study and 1 month after the intervention. Method of measurement: General Health Questionnaire. This questionnaire has four subscales of physical symptoms, anxiety, dysfunction and social function and depression, and the total score of each person is obtained from the sum of the scores of the four subscales. The General Health Questionnaire was first developed by Goldberg (1972).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Patient satisfaction. Timepoint: When discharging the studied samples from the hospital. Method of measurement: Patient Satisfaction Questionnaire that this questionnaire by Ameryoun ‎et al. (2017), in two dimensions of the health sector with 21 questions and three dimensions of health and Cleaning, nursing and doctors and non-medical department with 27 questions and six dimensions of admission Staff, nutrition, welfare and facilities, religious issues and discharge were localized.</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>Tehran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-05-05</approval_date>
        <contact_name>Ethics Committee of Tehran University of Medical Sciences</contact_name>
        <contact_address>School  of Nursing and Midwifery, Tehran University of Medical Sciences, Dr. Mirkhani St. (Nosrat Sharghi), Tohid Square, Tehran, Iran Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
