<?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>IRCT20220929056055N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-04-24</date_registration>
      <primary_sponsor>Tehran University of Medical Sciences</primary_sponsor>
      <public_title>The effect of comprehensive family-centered empowerment program on Adherence to Treatment and recovery process in patients after coronary angioplasty</public_title>
      <acronym></acronym>
      <scientific_title>The effect of comprehensive family-centered empowerment program on Adherence to Treatment and recovery process in patients after coronary angioplasty</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-03-11</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>84</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/68379</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Other, Purpose: Education/Guidance, Randomization description: The samples will be selected through continuous sampling and will be divided into two intervention and control groups. The sample members will be allocated in two intervention and control groups by random block allocation method with 4 blocks of equal size and a combination of letters A for the intervention group and B for the control group. Then, the cards containing the blocks are placed inside the standard envelope, and based on the eligible inpatient samples, an envelope will be selected by the researcher by random sampling method, and finally, the method of random allocation of research samples will be determined.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Coronary Artery Disease.</hc_freetext>
      <i_freetext>Intervention group: 8 family-centered intervention sessions will be conducted in the form of 5 group training sessions and 3 follow-up sessions and 1 session every week. Group meetings will be held in groups of 4 to 7 people for 20-30 minutes. During these sessions, he will provide training on the nature of the disease, factors affecting the aggravation or improvement of symptoms, methods of preventing heart diseases by modifying lifestyle, physical activity, proper nutrition, stress control methods, follow-up of drug therapy and adherence to the treatment plan. became. Then, the researcher will encourage the members of the intervention group to have a group discussion and exchange their experiences related to the disease and the complications they experienced and lifestyle. Also, the training booklet will be given to the sample members to read it and ask the researcher any questions that come to their mind. The family members attend the meetings and in these meetings under the supervision of the researcher, they will discuss their problems and how to solve them, which will finally end in adopting a solution and try to strengthen the patients' ability in this field. In the step of educational participation, the family members are asked to transfer the learned information to the patient in the presence of the researcher along with the educational card. The last meeting will be held with the presence of an active member of the family to review the received training and fix the problems and summarize the meetings and evaluate the model. Evaluation is done in two ways: Formative and Summative evaluation. Formative evaluation will be in the form of questions and answers during each session will be from the topics of the previous sessions, and the Summative evaluation will be for the completion of the questionnaires immediately after the intervention and the re-completion of the questionnaires will be done 4 weeks after the completion of the interventions. In order to comply with ethical considerations, the training booklet was also provided to the control group..</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>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is There is no further information.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Fatemeh Ardestani Mohammadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 28, Unit 1, Asgari Alley, 16 meters first North, Baath Blvd., Central Janat Abad</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1474854411</zip>
        <telephone>+98 21 4446 3174</telephone>
        <email>fatemeh.ardestani78@yahoo.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Shahrzad Ghiyasvandian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Nursing and Midwifery, Tehran University of Medical Sciences, Tawheed Square, Nusrat East St., Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1419733171</zip>
        <telephone>+98 21 6105 4517</telephone>
        <email>shghiyas@tums.ac.ir</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Adults from 18 to 60 years old
Diagnosis of coronary artery disease by a specialist doctor
Presence of patients on the waiting list for coronary angioplasty
The cooperation of one family member with the patient
Having minimum reading and writing literacy for the patient and active family member</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Psychological problems has been diagnosed
Failure to participate in a similar empowerment program</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>I70-I79</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>کد ذیل مربوط به بیماری های شریانی است.</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Behavior</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: 8 family-centered intervention sessions will be conducted in the form of 5 group training sessions and 3 follow-up sessions and 1 session every week. Group meetings will be held in groups of 4 to 7 people for 20-30 minutes. During these sessions, he will provide training on the nature of the disease, factors affecting the aggravation or improvement of symptoms, methods of preventing heart diseases by modifying lifestyle, physical activity, proper nutrition, stress control methods, follow-up of drug therapy and adherence to the treatment plan. became. Then, the researcher will encourage the members of the intervention group to have a group discussion and exchange their experiences related to the disease and the complications they experienced and lifestyle. Also, the training booklet will be given to the sample members to read it and ask the researcher any questions that come to their mind. The family members attend the meetings and in these meetings under the supervision of the researcher, they will discuss their problems and how to solve them, which will finally end in adopting a solution and try to strengthen the patients' ability in this field. In the step of educational participation, the family members are asked to transfer the learned information to the patient in the presence of the researcher along with the educational card. The last meeting will be held with the presence of an active member of the family to review the received training and fix the problems and summarize the meetings and evaluate the model. Evaluation is done in two ways: Formative and Summative evaluation. Formative evaluation will be in the form of questions and answers during each session will be from the topics of the previous sessions, and the Summative evaluation will be for the completion of the questionnaires immediately after the intervention and the re-completion of the questionnaires will be done 4 weeks after the completion of the interventions. In order to comply with ethical considerations, the training booklet was also provided to the control group.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The rate of patient recovery with the recovery process questionnaire. Timepoint: Before and after the intervention and 4 weeks after the end of the intervention. Method of measurement: Questionnaire of recovery process.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>The degree of compliance with the treatment plan in the questionnaire of adherence to treatment regimen. Timepoint: Before and after the intervention and 4 weeks after the end of the intervention. Method of measurement: Questionnaire of adherence to treatment regimen.</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>2022-09-28</approval_date>
        <contact_name>Ethics Committee in Research Faculty of Nursing and Midwifery and Rehabilitation Faculty of Tehran U</contact_name>
        <contact_address>Room 604, 6th floor, Tehran University of Medical Sciences office building, Intersection of Qods st., Keshavarz Blvd., Tehran Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
