<?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>IRCT20211122053151N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-12-27</date_registration>
      <primary_sponsor>University of social welfare and rehabilitation sciences</primary_sponsor>
      <public_title>The effect of self-management program based on 5A model on self-management ability and Symptoms of heart failure of the elderly</public_title>
      <acronym></acronym>
      <scientific_title>The effect of implementing a self-management program based on Model 5A on self-management ability and symptoms of heart failure in the elderly with chronic heart failure</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-01-10</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>80</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/60175</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Education/Guidance, Randomization description: Sequentially (numbered, opaque, sealed envelopes)
In this study, samples will be assigned to the intervention and control groups using sealed envelopes. In this way, 40 cards with the english letter A and 40 cards with the english letter B will be prepared and placed in sealed envelopes, and each patient will choose one of these cards at random without insertion, and if The choice of the letter A will be in the intervention group and if the card B is selected in the control group.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Heart failure.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: The self-management program based on model 5A, which includes 5 stages of assess, advise, agree, assist and arrange, will be implemented in the intervention group. In the first stage or assess, the problems of each person are identified, in the second stage based on the results of previous stage, the client is instructed about the problems and stressors. In the third stage or agree, the researcher and the client agree on the behavioral goals and plans to achieve those goals. In the fourth stage or assist, advice is given based on the needs of patients, by face-to-face oral instruction or handing out brochures. Finally, in the fifth stage, Follow-up will be done by phone and visit in the clinic. This program includes theoretical and practical training, as a program with the follow up of behavioral goals set during 12 weeks. In the first week, stage 1 ,2 and 3 will performed in an individual meeting (90 minutes). In the second and third week, will performed stage 4 in a group meeting (2 hours) and an individual meeting (60 minutes) and the stage 5 will performed from fourth to twelfth week of follow-up in next 2 months by phone call (daily phone call, in the first two weeks; twice a week phone call, in the next two weeks and then monthly calls) and face-to-face meeting (every four weeks). Intervention 2: Control group: The control group will receive the usual training (what is routinely taught in the clinic; such as reading educational pamphlets if desired).</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 Based on university regulations raw data will be kept in the custody of the main researcher or the Ethical Committee.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Darya shojaee</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>University of Social Welfare and Rehabilitation Sciences</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1985713834</zip>
        <telephone>+98 21 2218 0036</telephone>
        <email>daryashojaee99@gmail.com</email>
        <affiliation>University of social welfare and rehabilitation sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Farahnaz Mohammadi Shahbolaghi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Department of Nursing, School of Rehabilitation Sciences University of Social Welfare and Rehabilitation Sciences</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1985713834</zip>
        <telephone>+98 21 2218 0036</telephone>
        <email>f.mohammadi@uswr.ac.ir</email>
        <affiliation>University of social welfare and rehabilitation sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age over 60 years At least a third of secondary education the city of Babol and related countryside areas
Have cognitive health based on the Abbreviated Mental Test (AMT), ability to perform daily life activities (using ADL daily life activities tool)
Having second- and third-degree heart failure who have been ill for at least six months.
Do not have severe chronic illness (such as obstructive pulmonary disease, asthma (affecting the severity of respiratory symptoms and fatigue)</inclusion_criteria>
      <agemin>60 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Participation of individuals in similar studies
Having a fatal disease (eg, cancer)</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>N/A</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: The self-management program based on model 5A, which includes 5 stages of assess, advise, agree, assist and arrange, will be implemented in the intervention group. In the first stage or assess, the problems of each person are identified, in the second stage based on the results of previous stage, the client is instructed about the problems and stressors. In the third stage or agree, the researcher and the client agree on the behavioral goals and plans to achieve those goals. In the fourth stage or assist, advice is given based on the needs of patients, by face-to-face oral instruction or handing out brochures. Finally, in the fifth stage, Follow-up will be done by phone and visit in the clinic. This program includes theoretical and practical training, as a program with the follow up of behavioral goals set during 12 weeks. In the first week, stage 1 ,2 and 3 will performed in an individual meeting (90 minutes). In the second and third week, will performed stage 4 in a group meeting (2 hours) and an individual meeting (60 minutes) and the stage 5 will performed from fourth to twelfth week of follow-up in next 2 months by phone call (daily phone call, in the first two weeks; twice a week phone call, in the next two weeks and then monthly calls) and face-to-face meeting (every four weeks).</i_keyword>
      <i_keyword>Control group: The control group will receive the usual training (what is routinely taught in the clinic; such as reading educational pamphlets if desired).</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Self-management ability. Timepoint: Before and after intervention. Method of measurement: Self-management ability scale (SMAS).</prim_outcome>
      <prim_outcome>Fatigue severity. Timepoint: Before and after intervention. Method of measurement: Fatigue severity scal(FSS).</prim_outcome>
      <prim_outcome>Dyspnea. Timepoint: Before and after intervention. Method of measurement: Modified Medical Research Council(MMRC).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Hypertention. Timepoint: Before and after intervention. Method of measurement: Blood pressure machine.</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>University of social welfare and rehabilitation sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-11-17</approval_date>
        <contact_name>Ethics Committee of University of social welfare and rehabilitation sciences</contact_name>
        <contact_address>University of Social Welfare and Rehabilitation Sciences, koodakyar Blvd, Daneshjoo Stre, Evin Ave, Tehran. Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
