<?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>IRCT20130124012257N9</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-08-30</date_registration>
      <primary_sponsor>Zanjan University of Medical Sciences</primary_sponsor>
      <public_title>The effect of Roy adaptation model on fatigue and adherence to treatment in patients with MI</public_title>
      <acronym></acronym>
      <scientific_title>The effect of counseling based on Roy adaptation model on Multidimensional fatigue and adherence to treatment in patients with myocardial infarction</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-05-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>50</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/40091</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: In this study, the blocking method will be used. In the blocking technique, blocks are created with a pair size (usually four or six) blocks, in which randomly half the individuals of each block in one group and the other half In the other group. Then the block is chosen so as to reach the required sample size. In this study, to place 50 people in two groups of 25, first all four modes in which half of the subjects are group A and the other half are assigned to group B. These states are written below:
1 b b a a
2 b a b a
3- a b b a
4 a a b b
5- a b a b
6- b a a b
We then assign each of these four combinations one of the digits 1 to 6. In the next step, we need to select 13 random blocks of four blocks and write their combinations in succession. To do this, we need to put 6 samplers in this community 13 times. In this way we will have two groups: 25 in the control group and 25 in the test group, Blinding description: Participants in the study did not know about belonging to the intervention and control group.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Condition 1: Fatigue. Condition 2: Adherence to treatment.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: For the samples in the intervention group based on the form of exploring and recognizing the pattern of zinc adaptation, incompatible behaviors and the main, underlying and residual impulsive behaviors were identified in each of the four physiological dimensions, self-understanding, role play, autonomy, and dependence . A care program called counseling sessions consisting of 2 to 6 sessions of direct and individual intervention as variables according to patients' needs each time for a period of 45 to 30 minutes by the researcher and other members of the research team at the heart clinic affiliated to the Ayatollah Mousavi Hospital. was planned and implemented. Phone follow up for two months and then post-test. Intervention 2: Control group: In the control group, in order to control the effect of the professional medical sciences as an interventional variable, during the holding of the sessions to complete the questionnaires, the general questions of the samples, which had no relation to the main intervention of the researcher, were answered. Follow up for two Month and then post-test.</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 data file and report of the study method and results of this study will be published in a peer-reviewed journal.The data file in SPSS software can be presented on request by the relevant journal.

When:
2019-2020

To whom:
Officials, administrators, and supervisors associated with this study at Zanjan University of Medical Sciences have access to the data and documentation of this study while maintaining the confidentiality of the participants and observing ethical considerations.

Conditions:
The data of this study can be used for decision making by senior managers of Zanjan University of Medical Sciences, while protecting the confidentiality of participants and ethical considerations.

Where to obtain:
Farhad Ramezani Badr- Zanjan University of Medical Sciences

How to obtain:
Contact with the author responsible for this study- Farhad Ramezani Badr

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Seyedeh Maryam Hosseininezhad</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 57, Behruz Sharifian Ave., Felestin street, Rasht city</address>
        <city>Rasht</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4187697461</zip>
        <telephone>+98 13 3382 2166</telephone>
        <email>seyedehmaryam.hsn@gmail.com</email>
        <affiliation>Zanjan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Farhad Ramezani-Badr</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Nursing and Midwifery , Zanjan, Iran</address>
        <city>Zanjan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4515789589</zip>
        <telephone>+98 24 3377 2513</telephone>
        <email>ramazanibadr@zums.ac.ir</email>
        <affiliation>Zanjan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Having written consent to participate in the study and knowledge of the place and time
ability to communicate and call in the research period
History of myocardial infarction for at least three months
Moderate and severe fatigue, as well as adherence to good to low treatment based on the questionnaires used
Only one doctor is a cardiologist</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>There are known psychological disorders
Acute myocardial infarction
Having communication problems such as blindness, deafness and any cognitive impairment
Complications of myocardial infarction, such as heart failure, myocardial rupture, acute pulmonary edema, pericarditis, cardiogenic shock
The presence of any underlying illness that affects dependent variables.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Behavior</i_code>
      <i_code>Behavior</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: For the samples in the intervention group based on the form of exploring and recognizing the pattern of zinc adaptation, incompatible behaviors and the main, underlying and residual impulsive behaviors were identified in each of the four physiological dimensions, self-understanding, role play, autonomy, and dependence . A care program called counseling sessions consisting of 2 to 6 sessions of direct and individual intervention as variables according to patients' needs each time for a period of 45 to 30 minutes by the researcher and other members of the research team at the heart clinic affiliated to the Ayatollah Mousavi Hospital. was planned and implemented. Phone follow up for two months and then post-test.</i_keyword>
      <i_keyword>Control group: In the control group, in order to control the effect of the professional medical sciences as an interventional variable, during the holding of the sessions to complete the questionnaires, the general questions of the samples, which had no relation to the main intervention of the researcher, were answered. Follow up for two Month and then post-test.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Fatigue and its dimensions in the studied patients. Timepoint: This variable will be measurement once befor the intervention and again 2 month after the end of intervention. Method of measurement: Multidimensional fatigue inventory.</prim_outcome>
      <prim_outcome>Adherence to treatment. Timepoint: This variable will be measurement once befor the intervention and again 2 month after the end of intervention. Method of measurement: The scale of adherence to treatment questionnaire of Medical Outcomes Study.</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>Zanjan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-05-25</approval_date>
        <contact_name>Ethics committee of Zanjan University of Medical Sciences</contact_name>
        <contact_address>First of Jomhore Eslami Blvd, Azadi Square Zanjan Zanjan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
