<?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>IRCT20170731035424N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-09-19</date_registration>
      <primary_sponsor>Esfahan University of Medical Sciences</primary_sponsor>
      <public_title>The effect of an educational-supportive program on self-efficacy and quality of life of patients with ulcerative colitis</public_title>
      <acronym></acronym>
      <scientific_title>The effect of an educational-supportive program based on chronic care model on self-efficacy and health related quality of life of patients with ulcerative colitis</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-08-02</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>70</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/54337</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Before entering the study, the samples are divided into 8 groups, which are 4 groups of women with age group under 30 years, 30 to 40 years, 40 to 50 years, 50 years and above and 4 groups of men with the same division classification in terms of age. Then, randomly in each of the 8 groups, individuals are assigned to the control or intervention group, Blinding description: The data analyzer will not know which of the two intervention and control groups the data under analysis belongs to.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Ulcerative Colitis.</hc_freetext>
      <i_freetext>Intervention 1: The intervention group: the intervention group has a program containing 4 components of the chronic care model, including redesign of the care delivery system, self-management support, decision support, and the clinical information system or system which includes interventions such as delegating training and reminders and monitoring the practice of training, Answering questions and taking patients' histories, from doctor to nurse, in addition to following up on tests, procedures, patient status between visits and active management of the doctor's appointment with the nurse, educating the patient and providing various educational resources and psychosocial support Through conversations with peers, answering patients' questions is based on the results of recent studies in the field of ulcerative colitis and attention to their preferences for decisions about treatment and care and electronic recording of patient information and history. Intervention 2: Control group:  the control group will have only regular visits to the doctor as usual.</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:
By maintaining the confidentiality of participants' personal characteristics, the results of the study are shared based on the objectives of the study.

When:
Access will start immediately after the results are published in reputable journals

To whom:
If a request is sent to the responsible author of the article, due to the confidentiality of the participants' information, the decision on access to the results will be made.

Conditions:
If a request is sent to the responsible author of the article, due to the confidentiality of the participants' information, the use of the data will be decided.

Where to obtain:
people can correspond with the responsible author via the email contained in the article to receive data.

How to obtain:
A request can be made by correspondence with the responsible author of the article via email.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr. Sedigheh Farzi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Isfahan Faculty of Nursing and Midwifery, Department of Adult Health Nursing</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>81746-73461</zip>
        <telephone>+98 31 3792 7589</telephone>
        <email>Sedighehfarzi@nm.mui.ac.ir</email>
        <affiliation>Esfahan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Sedigheh Farzi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Isfahan Faculty of Nursing and Midwifery, Department  of Adult Health Nursing</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>81746-73461</zip>
        <telephone>+98 31 3792 7589</telephone>
        <email>Sedighehfarzi@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>Definitive diagnosis of ulcerative colitis With the approval of a specialist doctor and the results of colonoscopy and pathology
6 months after the diagnosis of ulcerative colitis and the stability of the drug phase during the study according to the doctor diagnose
Willingness to participate in the study
Not participating in the same study at the same time
The ability to use WhatsApp software by the patient or his primary caregiver
The possibility of making a telephone call to the patient
Age 18 to 65 years
Having the ability to understand Persian language</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>having confirmed mental illnesses (according to the patient and family statements)
Having other chronic diseases
Having Primary sclerosing cholangitis (inflammation of bile ducts)</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>K51</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Ulcerative colitis</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Lifestyle</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>The intervention group: the intervention group has a program containing 4 components of the chronic care model, including redesign of the care delivery system, self-management support, decision support, and the clinical information system or system which includes interventions such as delegating training and reminders and monitoring the practice of training, Answering questions and taking patients' histories, from doctor to nurse, in addition to following up on tests, procedures, patient status between visits and active management of the doctor's appointment with the nurse, educating the patient and providing various educational resources and psychosocial support Through conversations with peers, answering patients' questions is based on the results of recent studies in the field of ulcerative colitis and attention to their preferences for decisions about treatment and care and electronic recording of patient information and history.</i_keyword>
      <i_keyword>Control group:  the control group will have only regular visits to the doctor as usual.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Self-efficacy score based on Strategies Used by People to Promote Health questionnaire. Timepoint: Before the intervention, immediately and 3 months after the end of the intervention. Method of measurement: Strategies Used by People to Promote Health questionnaire.</prim_outcome>
      <prim_outcome>Health-related quality of life score based on Inflammatory Bowel Disease Questionnaire(IBDQ-9). Timepoint: Before the intervention, immediately and 3 months after the end of the intervention. Method of measurement: Inflammatory Bowel Disease Questionnaire (IBDQ-9).</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>2021-07-14</approval_date>
        <contact_name>Ethics committee of Isfahan University of Medical Science</contact_name>
        <contact_address>Hezar-Jerib Ave Isfahan Isfehan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
