<?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>IRCT20190917044802N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-02-05</date_registration>
      <primary_sponsor>Fasa University of Medical Sciences</primary_sponsor>
      <public_title>The Effect of Education on Quality of Life, Cardiac Anxiety and Adherence to Treatment in Heart Failure Patients</public_title>
      <acronym></acronym>
      <scientific_title>The Effect of Multimedia Education Based on  reflective learning on Quality of Life, Cardiac Anxiety and Adherence to therapeutic regimen in Patients with Heart Failure</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-08-06</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>120</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/42308</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Health service research, Randomization description: At first, sampling will be done by convenience method and then randomly divided into two groups of control and intervention. For this purpose, 120 cards will be provided first, 40 cards A, 40 cards B and 40 cards C, these 120 cards will be placed in an envelope and each patient will be asked to carry one card. Take a coincidence. Each card with the names A, B, C actually represents two intervention groups (multimedia learning ) , (multimedia learning with reflective learning)  and a control group).</study_design>
      <phase>4</phase>
      <hc_freetext>heart failure.</hc_freetext>
      <i_freetext>Intervention 1: In the first intervention group, multimedia education will be provided.The multimedia method will use video, slide show and educational pamphlets. The training program will be held in four two-hour sessions. The content of the training film will be produced with the advice of a cardiologist, nutritionist and psychologist and nursing faculty members. The film will be filmed at the Fasa University of Medical Sciences virtual training center and the educational content will be approved by the professors and director of the Department of Cardiology, Nutrition, Psychology and Nursing at Fasa University of Medical Sciences. Including 1- Symptoms and Symptoms of Heart Failure and Prevention of Heart Failure. Intervention 2: In the second intervention group, in addition to multimedia training, the training will be followed in a reflective learning based on the Johns model. This model consists of five steps -1. Event description: At this stage the event or experience describes the important causes and contextual factors associated with it, and in general, key issues in describing the event are addressed to clarify the experience.2. Reflection: This phase examines the thoughts and feelings of oneself and others and the consequences of the actions taken. Sample questions at this stage are: What was I trying to achieve? Why did I do it? What are the consequences of my actions [for the patient and family, for myself, for the people I work with]? When it happened, how did I feel about that experience? What was the patient feeling about it? How do I know what the patient is feeling about it?3. Investigating the influential factors: In this phase, the influence of internal, external and individual factors on the individual's decisions and actions is examined. Questions at this stage can include the following. What internal factors influenced my decision making and actions? What external factors influenced my decisions and actions? What sources of knowledge have or should have influenced my decision making and actions?4. Evaluating Alternative Strategies: At this point, the questions are: Could I handle this situation better? What other options were there for action? What were the consequences of the other choices?5. Learning: This stage describes the changes that have occurred in one's experiences, knowledge, ethical attitudes and self-awareness as a result of an event. An example of the question at this stage is: Given my past experience and future performance, how can I make sense of this experience? How do I feel about this experience right now? Am I considering taking effective action to support myself and others as a result of this experience? How has this experience changed my approach to performance? All stages of the Johns model will be discussed after viewing the film and based on the film content. Intervention 3: Control group: The control group will received a training package on heart failure.</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 consent form will be completed by the participants

When:
Complete the study and publish the article

To whom:
For researchers working in academic and scientific institutions

Conditions:
Implementation in other centers or other disease

Where to obtain:
Mostafa Bijani  Assistant Professor  Department of Nursing, School of Nursing and Midwifery Fasa University of Medical Science. bizhani _mostafa@yahoo.com

How to obtain:
Send project mananger email.  Mr. Mostafa Bijeni
bizhani_mostafa@yahoo.com

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mostafa Bijani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Fars Province, Fasa, Ibn Sina Square, Fasa University of Medical Sciences and Health Services</address>
        <city>Fasa</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>86688-74616</zip>
        <telephone>+98 71 5335 0994</telephone>
        <email>bizhani_mostafa@yahoo.com</email>
        <affiliation>Fasa University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mostafa Bijani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Fars Province, Fasa, Ibn Sina Square, Fasa University of Medical Sciences and Health Services</address>
        <city>Fasa</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>86688-74616</zip>
        <telephone>+98 71 5335 0994</telephone>
        <email>bizhani_mostafa@yahoo.com</email>
        <affiliation>Fasa University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>To under  55 years old,
Grade 1 to 3 heart failure,</inclusion_criteria>
      <agemin>40 years</agemin>
      <agemax>55 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Patients' unwillingness</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>I50.9</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>heart failure</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Lifestyle</i_code>
      <i_code>Other</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>In the first intervention group, multimedia education will be provided.The multimedia method will use video, slide show and educational pamphlets. The training program will be held in four two-hour sessions. The content of the training film will be produced with the advice of a cardiologist, nutritionist and psychologist and nursing faculty members. The film will be filmed at the Fasa University of Medical Sciences virtual training center and the educational content will be approved by the professors and director of the Department of Cardiology, Nutrition, Psychology and Nursing at Fasa University of Medical Sciences. Including 1- Symptoms and Symptoms of Heart Failure and Prevention of Heart Failure</i_keyword>
      <i_keyword>In the second intervention group, in addition to multimedia training, the training will be followed in a reflective learning based on the Johns model. This model consists of five steps -1. Event description: At this stage the event or experience describes the important causes and contextual factors associated with it, and in general, key issues in describing the event are addressed to clarify the experience.2. Reflection: This phase examines the thoughts and feelings of oneself and others and the consequences of the actions taken. Sample questions at this stage are: What was I trying to achieve? Why did I do it? What are the consequences of my actions [for the patient and family, for myself, for the people I work with]? When it happened, how did I feel about that experience? What was the patient feeling about it? How do I know what the patient is feeling about it?3. Investigating the influential factors: In this phase, the influence of internal, external and individual factors on the individual's decisions and actions is examined. Questions at this stage can include the following. What internal factors influenced my decision making and actions? What external factors influenced my decisions and actions? What sources of knowledge have or should have influenced my decision making and actions?4. Evaluating Alternative Strategies: At this point, the questions are: Could I handle this situation better? What other options were there for action? What were the consequences of the other choices?5. Learning: This stage describes the changes that have occurred in one's experiences, knowledge, ethical attitudes and self-awareness as a result of an event. An example of the question at this stage is: Given my past experience and future performance, how can I make sense of this experience? How do I feel about this experience right now? Am I considering taking effective action to support myself and others as a result of this experience? How has this experience changed my approach to performance? All stages of the Johns model will be discussed after viewing the film and based on the film content.</i_keyword>
      <i_keyword>Control group: The control group will received a training package on heart failure</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Quality of life. Timepoint: Immediately - one month later - three months later. Method of measurement: Minnesota Living with Heart Failure Questionnaire (MLHFQ).</prim_outcome>
      <prim_outcome>Cardiac Anxiety. Timepoint: Immediately - one month later - three months later. Method of measurement: The cardiac anxiety questionnaire Eifert.</prim_outcome>
      <prim_outcome>Adherence to treatment regimen. Timepoint: Immediately - one month later - three months later. Method of measurement: Morisky Medication Adherence Scale (MMAS).</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>Fasa University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-08-19</approval_date>
        <contact_name>Ethical Committee of Fasa University of Medical Sciences</contact_name>
        <contact_address>Fars Province, Fasa, Ibn Sina Square, Fasa University of Medical Sciences and Health Services Fasa Fars Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
