<?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>IRCT20161018030366N3</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-12-16</date_registration>
      <primary_sponsor>Bojnourd University of Medical Sciences</primary_sponsor>
      <public_title>The effect telenursing care on caregivers burden in family with Chronic Heart failure</public_title>
      <acronym></acronym>
      <scientific_title>The effect of family supportive program through telenursing care on caregivers burden in family with Congestive Heart failure in Bojnurd in 2019</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-12-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>66</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/43472</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: First, a list of all chronic heart failure patients admitted to Imam Hassan Hospital in Bojnourd during the past year will be compiled and the samples will be randomly divided into tele-nursing group and standard care group by random number table. Based on this, the researcher will go to the cardiology department and the sample will be selected based on which group the patient was previously in. To blind patients, sampling will be done at discharge so that other patients are not aware of the study method, Blinding description: Both groups of participants will be contacted by telephone and counseled, and neither participant will be aware of the actual intervention. In this study, the researchers will try not to be aware of the intervention group.for blinding the data analyzer, the study groups would be coded and thus the analyst would not know the nature of the groups.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Heart failure.</hc_freetext>
      <i_freetext>Intervention 1: The intervention in the tele-nursing group will consist of three parts: 1- Discharge training to family caregivers at discharge 2- Manage scheduled contacts 3- Remote monitoring of vital signs and weight of the patient at home. The discharge plan will be taught by a research nurse who is not a member of the patient treatment team. Through Booklet, he will teach family caregivers training on heart failure, medication, salt avoidance, fluid monitoring, exercise training, daily weight control and foot swelling, and limb time. Discharge planning training, training on how to measure vital signs, and working with tele-nursing equipment individually and face-to-face will be given to the patient's family caregiver prior to discharge. These tutorials will include how to use tele-nuring, how to measure physiological parameters and their importance. The patient contact plan will be conducted by one patient call coach. Patients will be given a heart failure educational booklet, a 7-day, one-month checklist and informed consent form. Patients in the intervention group should have an Internet-enabled smartphone and an approved information exchange software such as Whats App, Telegram or Soroush and a blood pressure monitor to measure blood pressure. Patient caregivers will be taught how to measure blood pressure, pulse rate, respiration and weighting to measure the physiological parameters of the patient on a daily basis and to upload the software. The call coach will teach caregivers about the pathophysiology of the disease, the symptoms, the treatment regimen and the fluid restriction. The call coach will provide caregivers a weekly counseling and pharmacy program. The phone caller will record and monitor patient vital information and weight information daily and provide feedback to caregivers. Will provide a patient visit if necessary. Intervention 2: Control group, Standard care: Common discharge plans for the standard care group will include a heart failure training booklet for family caregivers of patients to examine symptoms and symptoms, teach health care skills, and assist in understanding illness and facilities, and if they have problems call to call coach. The call coach should contact the family caregiver of the patients, actively and weekly after discharge, to inform them of the patient's condition and to provide counseling if needed.</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 For greater security of participants' data</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mohammad Ghaderi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahryar Street, Emam Ali Blvd, School of nursing</address>
        <city>Bojnurd</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9678694176</zip>
        <telephone>+98 58 3229 7095</telephone>
        <email>ghaderi.mohammad1@gmail.com</email>
        <affiliation>Bojnourd University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mohammad Ghaderi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Sharyar Ave, Emam Ali Blvd, School of nursing</address>
        <city>Bojnurd</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9678694176</zip>
        <telephone>+98 58 3229 7095</telephone>
        <email>m.ghaderi@nkums.ac.ir</email>
        <affiliation>Bojnourd University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>At least six months have passed since the diagnosis of heart failure.
The patient has a family.
The patient has a family caregiver who has the highest share of patient care.
Have a caregiver over 18 years of age.
Lack of family caregivers with mental disorder and chronic diseases
Ability to read and respond to the Farsi questionnaire.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Not be able to provide appropriate telemedicine care after receiving trained nursing education
Not able to communicate with telemedicine for 2 weeks.
If the patient also has a private nurse and the patient's caregiver uses other educational programs.</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>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>The intervention in the tele-nursing group will consist of three parts: 1- Discharge training to family caregivers at discharge 2- Manage scheduled contacts 3- Remote monitoring of vital signs and weight of the patient at home. The discharge plan will be taught by a research nurse who is not a member of the patient treatment team. Through Booklet, he will teach family caregivers training on heart failure, medication, salt avoidance, fluid monitoring, exercise training, daily weight control and foot swelling, and limb time. Discharge planning training, training on how to measure vital signs, and working with tele-nursing equipment individually and face-to-face will be given to the patient's family caregiver prior to discharge. These tutorials will include how to use tele-nuring, how to measure physiological parameters and their importance. The patient contact plan will be conducted by one patient call coach. Patients will be given a heart failure educational booklet, a 7-day, one-month checklist and informed consent form. Patients in the intervention group should have an Internet-enabled smartphone and an approved information exchange software such as Whats App, Telegram or Soroush and a blood pressure monitor to measure blood pressure. Patient caregivers will be taught how to measure blood pressure, pulse rate, respiration and weighting to measure the physiological parameters of the patient on a daily basis and to upload the software. The call coach will teach caregivers about the pathophysiology of the disease, the symptoms, the treatment regimen and the fluid restriction. The call coach will provide caregivers a weekly counseling and pharmacy program. The phone caller will record and monitor patient vital information and weight information daily and provide feedback to caregivers. Will provide a patient visit if necessary.</i_keyword>
      <i_keyword>Control group, Standard care: Common discharge plans for the standard care group will include a heart failure training booklet for family caregivers of patients to examine symptoms and symptoms, teach health care skills, and assist in understanding illness and facilities, and if they have problems call to call coach. The call coach should contact the family caregiver of the patients, actively and weekly after discharge, to inform them of the patient's condition and to provide counseling if needed.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Family Caregiver burden. Timepoint: Pre- intervention. Method of measurement: 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>Bojnourd University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-10-27</approval_date>
        <contact_name>Ethics Committee of North Khorasan University of Medical Sciences</contact_name>
        <contact_address>Shahryar Street, School of Nursing Bojnurd North Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
