<?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>IRCT20200411047028N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-06-15</date_registration>
      <primary_sponsor>Sanandaj University of Medical Sciences</primary_sponsor>
      <public_title>Collaborative Care Model in Heart Failure</public_title>
      <acronym></acronym>
      <scientific_title>The Effect of Training Based on Collaborative Care Model on Health Promotion Behaviors and Self-Efficacy in Heart Failure Patients Referred to Imam Khomeini Hospital in Saghez, 2019.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-01-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/47443</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: After preparing a list of all patients with inclusion criteria, a simple random sampling method of a random number table will be used. Thus members of the community are numbered from 1 to N, then a row and a column are randomly selected, the intersection of the row and the column is the starting point for sampling. From this point and at the choice of the researcher, one direction (top, bottom, right or left) will continue to select the samples until the desired number (60) is reached.Because the samples were obtained from a larger population and based on the allocation of numbers to individuals, they are placed in the table from the beginning, and even the researcher himself does not know from the beginning of the study who the assigned number belongs to, using a random table of numbers to get a sample of the homogeneous community (the community has similar conditions for entering the study) so that the chances of being selected as a sample are the same for all and the condition of random selection of the sample is observed, in the next step, after obtaining the required 60 samples, the odd and even methods will be used to assign the samples to the intervention and control groups. In this way, based on the contractual procedure, the obtained odd numbers (thirty persons obtained from the random table of numbers) are assigned to the intervention group and the obtained even numbers (thirty pairs obtained from the random table of numbers) are assigned to the control group. That is, the randomization process is first selected to select the required sample based on the random table of numbers, and in the next step, the sample obtained based on the odd and evenness of the specific number obtained from the random table of numbers is assigned to two groups of intervention and control. The purpose of this work is to observe randomness and equal chance in both stages.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Heart Failure Patients.</hc_freetext>
      <i_freetext>Intervention 1: intervention gruop:in this group intervention containing education-based on collaborative care model will be performed in a systematic framework for three months in the forms of sessions a) Educational-Participatory visits and b) Follow-up visits.The educational-participatory sessions themselves include two stages of motivation and readying, which include 3 sessions with an interval of 10 days. In the first session, which is the first stage, ie the motivational stage, in a two-hour session, with the help of a clinical psychologist, cardiologist and nurse, the samples will be stimulated by identifying the needs to express the importance of client participation in the care process.In the second stage, readying, in 2 one-hour sessions with the help of cardiologist and nurse will be paid to inform clients about participatory educational visits as lectures, group discussions, powerpoint, photos and videos about heart failure, treatment process and the importance of long-term care. Follow-up visits include the last two stages of the collaborative care model, the involvement and evaluation stages. The involvement phase will include 4 sessions with two-week intervals, which is in fact a continuation of the preparation phase, with the aim of continuing the training of the care process, modifying programs, and transferring experiences. The evaluation stage is the last stage of this model, which will be in two forms of step by step and final evaluation.Step-by-step evaluation is in fact one of the first follow-up visits to improve programs and meetings and encourage the clients to continue participating in the training program. The final evaluation will be at the end of the third month and the questionnaires will be re-implemented. Intervention 2: Intervention group: In this group members, will not recieve any education or intervention, but routine care and visits to maintain minimal resemblance to the structure of participatory care sessions by a respected cardiologist will be performed once a month for two weeks and, like the intervention group, in the control group. Also, after the end of the third month, the questionnaires will.</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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is Observance of the principle of confidentiality</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Semko Mohammadzadeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Pasdaran street, opposite the hotel Shadi</address>
        <city>Sanandaj</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6617764671</zip>
        <telephone>+98 87 3622 0997</telephone>
        <email>semkomohamadzade@gmail.com</email>
        <affiliation>Sanandaj University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Nazila Olyaee</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Pasdaran street, opposite the hotel Shadi</address>
        <city>Sanandaj</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6617764671</zip>
        <telephone>+98 918 872 2616</telephone>
        <email>nazilaolyaie58@gmail.com</email>
        <affiliation>Sanandaj University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>The desire to participate in the study
Definitive diagnosis of heart failure based on opinion of a cardiologist, clinical and paraclinical evidence (echocardiography) with a jump in the left ventricle less than 45%
Age range 18 to 65 years
Possibility of verbal and non-verbal communication</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Unwillingness to participation with study method
Patients with heart failure in 1 and 4 stages
Physical or mental illness or physical disability that restricts cooperation in research project
Patients with impaired level of consciousness
Malignant diseases such as cancer
Simultaneous participation in heart failure training programs
Participation history in collaborative care model training sessions</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>I50</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>Lifestyle</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>intervention gruop:in this group intervention containing education-based on collaborative care model will be performed in a systematic framework for three months in the forms of sessions a) Educational-Participatory visits and b) Follow-up visits.The educational-participatory sessions themselves include two stages of motivation and readying, which include 3 sessions with an interval of 10 days. In the first session, which is the first stage, ie the motivational stage, in a two-hour session, with the help of a clinical psychologist, cardiologist and nurse, the samples will be stimulated by identifying the needs to express the importance of client participation in the care process.In the second stage, readying, in 2 one-hour sessions with the help of cardiologist and nurse will be paid to inform clients about participatory educational visits as lectures, group discussions, powerpoint, photos and videos about heart failure, treatment process and the importance of long-term care. Follow-up visits include the last two stages of the collaborative care model, the involvement and evaluation stages. The involvement phase will include 4 sessions with two-week intervals, which is in fact a continuation of the preparation phase, with the aim of continuing the training of the care process, modifying programs, and transferring experiences. The evaluation stage is the last stage of this model, which will be in two forms of step by step and final evaluation.Step-by-step evaluation is in fact one of the first follow-up visits to improve programs and meetings and encourage the clients to continue participating in the training program. The final evaluation will be at the end of the third month and the questionnaires will be re-implemented</i_keyword>
      <i_keyword>Intervention group: In this group members, will not recieve any education or intervention, but routine care and visits to maintain minimal resemblance to the structure of participatory care sessions by a respected cardiologist will be performed once a month for two weeks and, like the intervention group, in the control group. Also, after the end of the third month, the questionnaires will</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Health Promotion Behaviors. Timepoint: Pre test- Post test. Method of measurement: Health Promotion Lifestyle Profile II (HPLP II).</prim_outcome>
      <prim_outcome>Self-Efficacy. Timepoint: Pre test- Post test. Method of measurement: Sullivan self-efficacy 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>Sanandaj University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-12-29</approval_date>
        <contact_name>Ethics Committee of Sanandaj University of Medical Sciences</contact_name>
        <contact_address>Pasdaran street, opposite the hotel Shadi Sanandaj Kurdistan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
