<?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>IRCT20211213053389N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-02-19</date_registration>
      <primary_sponsor>Kerman University of Medical Sciences</primary_sponsor>
      <public_title>The effect of palliative care at home on the quality of life</public_title>
      <acronym></acronym>
      <scientific_title>The effect of palliative care at home on the quality of life of the elderly with heart failure discharged from the heart wards</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-03-06</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>100</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/61466</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Samples will be selected by continuous sampling, and patients will be divided into control and test groups by Block Balanced Randomization (BBR). The allocation sequence will be done using the free web system http://www.randomization.com/. In this way, the number of subjects in each block is determined by 5 people and the letter A will be considered for the control group and the letter B will be considered for the experimental group. The assignment sequence will be created for 100 samples by combining the letters A and B. Finally, the cards containing the blocks will be placed inside the standard envelope, and as a result, the Allocation Concealment will be considered and observed. Based on the eligible samples, an envelope shuffling envelope will be randomly removed by the researcher, and the method of randomly assigning the research samples will be determined.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Heart Failure.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: After the initial visit, which will be performed jointly by a cardiologist and a researcher, in addition to receiving routine care in heart failure, they will be placed in palliative care twice a week for eight and a half hours in eight individual sessions. The educational content will first be narrated by experts in the field of palliative care to determine the validity and quality of education and then will be implemented by the researcher. The intervention includes the following topics: 1. Familiarity with heart failure, 2. Providing an introduction to the importance and necessity of self-care training in psychological and physical dimensions and monitoring symptoms, 3. Needs assessment of care of various organs of the body, physical effects, Psychology and Behavior of the Elderly and Family, 4. Assessing the Self-Care Ability, Stressful Situations, Social Interactions and the Elderly Relationship and Life and the Effects of Death Anxiety and Family Support and Emotional and Spiritual Support, 5. Implementing the Elderly and Family Client Education Programs Based on self-care needs, 6. Review coping strategies in stressful situations, and ways to cope with stress and depression, 7. Strengthen self-confidence, self-esteem, coping with anxiety and inefficiency. 8. At the end, review the previous sessions, prepare the family to complete the group sessions, focus on performing self-care activities. At the beginning of the sessions, patients will be members of the virtual groups. The researcher asks them to inform him / her if he / she has any questions about the research, and also asks the patients to express their successful and unsuccessful experiences in relation to the issues raised. Finally, after the intervention, patients will be followed for a month, during which the researcher will answer possible questions from patients in virtual groups. Intervention 2: Control group: After the initial visit, which will be performed jointly by a cardiologist and a researcher, patients will be provided with routine care in 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>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 No program has been developed to provide the data yet</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mohammad hossein Khajehpoor</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Razi School of Nursing and Midwifery, University of Medical Sciences campus, At the beginning of Haft Bagh Alavi axis, Kerman</address>
        <city>Kerman</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7616913555</zip>
        <telephone>+98 34 3132 5219</telephone>
        <email>Khajehpoor_m@yahoo.com</email>
        <affiliation>Kerman University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Esmat Nouhi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Razi School of Nursing and Midwifery, University of Medical Sciences campus, At the beginning of Haft Bagh Alavi axis, Kerman</address>
        <city>Kerman</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7616913555</zip>
        <telephone>+98 34 3132 5119</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>The elderly with a certain diagnosis of chronic heart failure
Ability to communicate and non - speech problems and hearing problems
Lack of mental illness
Full consciousness at the time of research
Willingness to participate in research</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>In case of unstable physical and emergency conditions (change in vital signs and inability of the patient to attend class)
Failure to attend more than two training sessions
Failure to answer more than a third of the questions</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: After the initial visit, which will be performed jointly by a cardiologist and a researcher, in addition to receiving routine care in heart failure, they will be placed in palliative care twice a week for eight and a half hours in eight individual sessions. The educational content will first be narrated by experts in the field of palliative care to determine the validity and quality of education and then will be implemented by the researcher. The intervention includes the following topics: 1. Familiarity with heart failure, 2. Providing an introduction to the importance and necessity of self-care training in psychological and physical dimensions and monitoring symptoms, 3. Needs assessment of care of various organs of the body, physical effects, Psychology and Behavior of the Elderly and Family, 4. Assessing the Self-Care Ability, Stressful Situations, Social Interactions and the Elderly Relationship and Life and the Effects of Death Anxiety and Family Support and Emotional and Spiritual Support, 5. Implementing the Elderly and Family Client Education Programs Based on self-care needs, 6. Review coping strategies in stressful situations, and ways to cope with stress and depression, 7. Strengthen self-confidence, self-esteem, coping with anxiety and inefficiency. 8. At the end, review the previous sessions, prepare the family to complete the group sessions, focus on performing self-care activities. At the beginning of the sessions, patients will be members of the virtual groups. The researcher asks them to inform him / her if he / she has any questions about the research, and also asks the patients to express their successful and unsuccessful experiences in relation to the issues raised. Finally, after the intervention, patients will be followed for a month, during which the researcher will answer possible questions from patients in virtual groups.</i_keyword>
      <i_keyword>Control group: After the initial visit, which will be performed jointly by a cardiologist and a researcher, patients will be provided with routine care in heart failure.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Quality of life score in the Ferrans and Powers quality of life index, cardiac version - IV. Timepoint: Measurement of quality of life at the beginning of the study (before the intervention), after the intervention and 1 month after the intervention. Method of measurement: Ferrans and Powers quality of life index, cardiac version - IV.</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>2022-02-07</approval_date>
        <contact_name>Ethics committee of Kerman University of Medical Sciences</contact_name>
        <contact_address>Beginning of Ibn Sina Street, first Jihad Blvd., Somayeh intersection, Kerman Kerman Kerman Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
