<?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>IRCT20231223060506N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2024-01-21</date_registration>
      <primary_sponsor>Kerman University of Medical Sciences</primary_sponsor>
      <public_title>"The effects of palliative care on anxious thoughts and life expectancy in patients with heart failure referred to the heart departments hospitals"</public_title>
      <acronym></acronym>
      <scientific_title>"The effects of palliative care on anxious thoughts and life expectancy in patients with heart failure</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2024-02-09</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>80</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/74666</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: The samples will be selected by continuous sampling and the patients will be placed in 2 control and test groups by Block Balanced Randomization method. Allocation sequence will be done using the free web system http://www.randomization.com/.In this way, the number of samples in each block is determined by 4 people and the letter A will be considered for the intervention group and the letter B will be considered for the control group. And finally, by confirming the creation of the allocation sequence in the above system for 20 blocks, the allocation sequence for 80 samples will be created by combining the letters A and B. Finally, the cards containing the blocks will be placed inside the governor's envelope, and as a result, the concealment of the allocation will be considered and respected. Based on the qualified samples, an envelope will be removed by the researcher using random sampling method and finally the method of random allocation of research samples will be determined.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Heart Failure.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: The intervention group includes patients with heart failure referred to the heart departments of hospitals affiliated to Kerman University of Medical Sciences. The intervention group receives the educational protocol along with routine care. The educational protocol of the study includes a two-week palliative care program in the form of one-hour training sessions, four times a week. The educational content is narrated by experts in the field of palliative care, and will be implemented by a researcher who is trained through a supervisor who is a professor of palliative medicine. In the first week of the sessions, when the patients are in the hospital, it will be performed individually for the patients. At the time of discharge, they are asked to go to the hospital in order to receive the continuation of the palliative care program on certain days, and the continuation of the educational sessions in the second week for the patients is carried out in the patient education center in groups (small groups) in coordination with the relevant hospitals. The content of the program is mostly related to the aspects of increasing the awareness and knowledge of patients in relation to their disease, increasing the aspects of self-care, techniques to control anxiety and anxious thoughts, and ways to increase self-confidence. During the intervention, the researcher will evaluate, educate and counsel the patients in the first session. Patients' knowledge and ability in self-management, family support system, and their educational and counseling needs, including heart failure symptoms and self-care, will be evaluated. An educational brochure will also be provided to patients. During the first week, when the meetings are held individually, the guidelines for heart failure will be explained and the researcher will provide emotional support to the patients by encouraging them to express their feelings. She will actively listen to the patient's responses by encouraging them to express their feelings and it will support them in taking small steps to solve the problem. And in the second week, the meetings are in groups , It will be explained in relation to the solutions of having a healthy lifestyle and strengthening your spirit, and how to control and manage the disease and strengthen self-confidence. Intervention 2: Control group: Usual care in heart failure will be provided to patients.</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 The plan for providing the data has not been developed yet.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Rezvan Askarpour</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Razi Midwifery Nursing School,Kerman University of Medical Sciences, Haft Bagh Road first، Kerman</address>
        <city>Kerman</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7616913555</zip>
        <telephone>+98 34 3132 5219</telephone>
        <email>re.askarpour7879@gmail.com</email>
        <affiliation>Kerman University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Esmat Nouhi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Razi Midwifery Nursing School,Kerman University of Medical Sciences, Haft Bagh Road first، Kerman</address>
        <city>kerman</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7616913555</zip>
        <telephone>+98 34 3132 5219</telephone>
        <email>smnouhi@yahoo.com</email>
        <affiliation>Kerman University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age over 18 years
Having heart failure
Ability to understand and speak Persian
Ability to answer questionnaire questions</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Not participating in more than two training sessions
Not answering more than a third of the questions
Sensory disorders such as vision and hearing problems that affect learning</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>Behavior</i_code>
      <i_code>Behavior</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: The intervention group includes patients with heart failure referred to the heart departments of hospitals affiliated to Kerman University of Medical Sciences. The intervention group receives the educational protocol along with routine care. The educational protocol of the study includes a two-week palliative care program in the form of one-hour training sessions, four times a week. The educational content is narrated by experts in the field of palliative care, and will be implemented by a researcher who is trained through a supervisor who is a professor of palliative medicine. In the first week of the sessions, when the patients are in the hospital, it will be performed individually for the patients. At the time of discharge, they are asked to go to the hospital in order to receive the continuation of the palliative care program on certain days, and the continuation of the educational sessions in the second week for the patients is carried out in the patient education center in groups (small groups) in coordination with the relevant hospitals. The content of the program is mostly related to the aspects of increasing the awareness and knowledge of patients in relation to their disease, increasing the aspects of self-care, techniques to control anxiety and anxious thoughts, and ways to increase self-confidence. During the intervention, the researcher will evaluate, educate and counsel the patients in the first session. Patients' knowledge and ability in self-management, family support system, and their educational and counseling needs, including heart failure symptoms and self-care, will be evaluated. An educational brochure will also be provided to patients. During the first week, when the meetings are held individually, the guidelines for heart failure will be explained and the researcher will provide emotional support to the patients by encouraging them to express their feelings. She will actively listen to the patient's responses by encouraging them to express their feelings and it will support them in taking small steps to solve the problem. And in the second week, the meetings are in groups , It will be explained in relation to the solutions of having a healthy lifestyle and strengthening your spirit, and how to control and manage the disease and strengthen self-confidence.</i_keyword>
      <i_keyword>Control group: Usual care in heart failure will be provided to patients.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Anxious thoughts. Timepoint: Anxiety thoughts will be measured before the intervention and immediately after the intervention. Method of measurement: Wells  Anxious thoughts Scale.</prim_outcome>
      <prim_outcome>Life expectancy. Timepoint: Life expectancy will be measured before the intervention and immediately after the intervention. Method of measurement: Schneider life expectancy scale.</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>Kerman University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-12-11</approval_date>
        <contact_name>Ethics Committee of Kerman University of Medical Sciences</contact_name>
        <contact_address>Kerman University of Medical Sciences, The beginning of Haft Bagh Road, Kerman Kerman Kerman Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
