<?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>IRCT2016010625880N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2016-05-12</date_registration>
      <primary_sponsor>Ahvaze University of Medical Sciences</primary_sponsor>
      <public_title>The Effect of Education on Quality of Life in Patients With Heart Failure</public_title>
      <acronym></acronym>
      <scientific_title>The Effect of Roy’s Adaptation Model-Based Patient Education on The Quality of Life of Patients with Heart Failure</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2015-12-19</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>76</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/21597</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Heart Failure.</hc_freetext>
      <i_freetext>Intervention 1: Control Group Did not Receive Behavioral Intervention and Receive only Treatment Routine Care. Intervention 2: Type of Intervention Is Behavioral, In addition to routine medical cares, the intervention group will receive weekly 45-minute sessions of Roy's Adaptation Model-based training for one month. This group will also receive a follow-up procedure through phone contact, during which the positive behaviors of the patients will be encouraged and strengthened by stating the advantages of such behaviors; whereas, their negative behaviors will be undermined by mentioning their complications and disadvantages. The intervention group will also receive telephone and physically individual consultation. The educational content will be gathered and developed based on nursing and medical literature review. Presentation of educational content during the 4 sessions will be as follows: • The first session: definition of heart failure, signs and symptoms of the disease, how to perform exercise and physical activities.• The second session: diet and fluid intake, tobacco use, alcohol consumption, daily weighing and its interpretation.• The third session: training in medications, their complications, and how to adjust drug dosing.• The fourth session: Management of and adaptation to symptoms, sexual problems, and stresses. If patients need more help to shape adaptation behaviors, they will be referred to other treatment team members based on the type of behavior and its stimulator (e.g. referral to a specialized physician for drug dosing adjustment). The researcher will provide patients with continuous follow-ups from the beginning of the intervention onward. In fact, these telephone follow-ups and the time spent on visiting patients physically and individually, will create a sense of support in them, which is associated with psychologically positive effect. During the whole program, patients will be encouraged to have one companion in training sessions. A handout, entitled.</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></results_IPD_plan>
      <results_IPD_description></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Doctor Shahram Baraz</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Nursing, Ahvaze University of Medical Sciences, Gholstan Highway, Ahvaze, Khuzestan</address>
        <city>Ahvaz-</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>00986133738333</zip>
        <telephone>00</telephone>
        <email>shahrambaraz@yahoo.com</email>
        <affiliation>Ahvaz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Akram Mansouri</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Nursing, Ahvaze University of Medical Sciences, Gholstan Highway, Ahvaze, Khuzestan</address>
        <city>Ahvaze</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>00989353772927</zip>
        <telephone>00</telephone>
        <email>Mansouri.A@ajums.ac.ir</email>
        <affiliation>Ahvaz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria are: diagnosis of class I, II, III heart failure by a physician, according to the American Heart Association and clinical and laboratory evidence, at least 6 months before the study; ejection fraction of 40% or below;  no mental disorder; normal hearing, vision and mental capabilities that allow making communication; age range from 18 to 65 years; no contraction of other chronic diseases such as kidney or liver failure, chronic pulmonary obstructive diseases, and neural and motor disorders, except diabetes; having access to patients for follow-up controls; walking capability; and not receiving the same training in other centers. Exclusion criteria include: unwillingness to participate for any reason; moving from the research region during the study; and more than two times absence from training sessions.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>150.20و150</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Chronic Systolic (Congestive) 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>Control Group Did not Receive Behavioral Intervention and Receive only Treatment Routine Care.</i_keyword>
      <i_keyword>Type of Intervention Is Behavioral, In addition to routine medical cares, the intervention group will receive weekly 45-minute sessions of Roy's Adaptation Model-based training for one month. This group will also receive a follow-up procedure through phone contact, during which the positive behaviors of the patients will be encouraged and strengthened by stating the advantages of such behaviors; whereas, their negative behaviors will be undermined by mentioning their complications and disadvantages. The intervention group will also receive telephone and physically individual consultation. The educational content will be gathered and developed based on nursing and medical literature review. Presentation of educational content during the 4 sessions will be as follows: • The first session: definition of heart failure, signs and symptoms of the disease, how to perform exercise and physical activities.• The second session: diet and fluid intake, tobacco use, alcohol consumption, daily weighing and its interpretation.• The third session: training in medications, their complications, and how to adjust drug dosing.• The fourth session: Management of and adaptation to symptoms, sexual problems, and stresses. If patients need more help to shape adaptation behaviors, they will be referred to other treatment team members based on the type of behavior and its stimulator (e.g. referral to a specialized physician for drug dosing adjustment). The researcher will provide patients with continuous follow-ups from the beginning of the intervention onward. In fact, these telephone follow-ups and the time spent on visiting patients physically and individually, will create a sense of support in them, which is associated with psychologically positive effect. During the whole program, patients will be encouraged to have one companion in training sessions. A handout, entitled</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Quality of Life. Timepoint: Before Intervention and one Month After Intervention. Method of measurement: Minnesota Questionnaire, Roy Questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Adaptation. Timepoint: before itervention and one month after intervention. Method of measurement: Roy Questionnaire.</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>Ahvaze University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2015-12-19</approval_date>
        <contact_name>Ahvaze University of Medical Sciences</contact_name>
        <contact_address>Ahvaze University of Medical Sciences, Gholestan Square, Ahvaze, Khuzestan, Iran Ahvaze  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
