<?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>IRCT20120910010806N10</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-05-21</date_registration>
      <primary_sponsor>Iran University of Medical Sciences</primary_sponsor>
      <public_title>Occupational Performance Coaching on Self-Care Behavior,Participation Level and Depression in Adults With Heart Failure</public_title>
      <acronym></acronym>
      <scientific_title>Occupational Performance Coaching on Self-Care Behavior,Participation Level and Depression in Adults With Heart Failure</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-05-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>40</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/54116</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Blocked randomization, After selecting the samples in a non-probability simple method, participants will be randomly divided into two groups. Random allocation to the two groups in this study will be done using four and six blocks. The order of the blocks will be selected web-based. Randomization in this study will be done by one of the research colleagues and other researchers and the person performing the intervention will not know about the assignment of groups, Blinding description: Assessor and will be blind in this study.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Heart Failure.</hc_freetext>
      <i_freetext>Intervention 1: intervention group: Includes the heart failure patients referred to Rajaie Cardiovascular, Medical and Research Center , which are treated according to the OPC (occupational performance =Coaching) protocol. In the pilot phase, the OPC is performed in 8 sessions individually by the researcher. Intervention 2: Control group: A standard self-care training session of Rajaie Cardiovascular, Medical and Research Center is performed as a usual care for them.</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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
Article Published

When:
6 months after publication

To whom:
The researchers and Occupational Therapists

Conditions:
Other research, critics, check and clinical usage

Where to obtain:
First author and corresponding author

How to obtain:
Send Request by Email

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Zahra Ahmadizadeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Occupational Therapy department, School of rehabilitation sciences., Madadkaran Alley., Shah-Nazari Ave.,Madar Sq.,Mirdamad Blvب</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1545913487</zip>
        <telephone>+98 21 2222 2059</telephone>
        <email>ahmadizade.z@gmail.com</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr Malahat Akbarfahimi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Occupational Therapy depatrment., School of rehabilitation., Madadkaran Ave., Shah-Nazari Ave., Madar Sq., Mirdamad Blvd</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1545913478</zip>
        <telephone>+98 21 2222 2059</telephone>
        <email>akbarfahimi.m@iums.ac.ir</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients aged between 18 and 65 years
clinical diagnosis of HF levels 1, 2 and 3 according to the New York Heart Association classification system (NYHA) by a cardiologist and left ventricular ejection fraction less than 40% based on echocardiography
Have acute coronary artery syndrome for the past 2 weeks or coronary artery bypass graft disease or medical surgery based on a diagnosis made by a cardiologist
be able to read, write and fill out questionnaires
not having severe depression based on the CDS questionnaire (scoring less than 100)
having good cognitive function (score above 22 in MMSE test)
having a score less than 70 in self-care behavior scale</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>History of claudication, clinical instability, ventricular arrhythmia, primary valve disease, congenital heart disease, hypertrophic or restrictive cardiomyopathy,  myocarditis, COPD and pericardial effusion, and  history of myocardial infarction in the previous month,  acute coronary artery syndrome during the last 2 weeks or patients with coronary artery bypass graft or heart surgery, , , , i
Being a recipient of other occupational therapy services
Having vision and hearing problems that prevent communication
Hospitalization at the time of implementing the intervention,
Living in maintenance institutions
Having unstable angina or high blood pressure
Having any psychiatric disorder treated based on medical documentation
Having any neurological or psychological disorders that impair the ability to walk or cognitive function
Infection with COVID-19 at the time of intervention
Having myocarditis, severe COPD and pericardial effusion and a history of myocardial infarction in the previous month and uncontrolled diabetes and kidney failure based on medical documentation</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>intervention group: Includes the heart failure patients referred to Rajaie Cardiovascular, Medical and Research Center , which are treated according to the OPC (occupational performance =Coaching) protocol. In the pilot phase, the OPC is performed in 8 sessions individually by the researcher.</i_keyword>
      <i_keyword>Control group: A standard self-care training session of Rajaie Cardiovascular, Medical and Research Center is performed as a usual care for them.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Self-care Behavior. Timepoint: Before the intervention, after the end of the intervention and in the follow-up, one month after the end of the intervention. Method of measurement: self-care of heart failure index.</prim_outcome>
      <prim_outcome>Participation. Timepoint: Before the intervention, after the end of the intervention and in the follow-up, one month after the end of the intervention. Method of measurement: Canadian Occupational Performance Measure.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Self-efficacy. Timepoint: Before the intervention, after the end of the intervention and in the follow-up period one month after the end of the intervention. Method of measurement: Cardiovascular Management Self Efficacy Scale.</sec_outcome>
      <sec_outcome>Quality of life. Timepoint: Before the intervention, after the end of the intervention and in the follow-up period one month after the end of the intervention. Method of measurement: Minnesota Living with Heart Failure Questionnaire.</sec_outcome>
      <sec_outcome>Physical Functional Capacity. Timepoint: Before the intervention, after the end of the intervention and in the follow-up period one month after the end of the intervention. Method of measurement: 6 Minute Walk Test.</sec_outcome>
      <sec_outcome>Activity of Daily Living. Timepoint: Before the intervention, after the end of the intervention and in the follow-up period one month after the end of the intervention. Method of measurement: Lawton questionnaires.</sec_outcome>
      <sec_outcome>Fatigue. Timepoint: Before the intervention, after the end of the intervention and in the follow-up period one month after the end of the intervention. Method of measurement: Fatigue Severity Scale.</sec_outcome>
      <sec_outcome>Depression. Timepoint: Before the intervention, after the end of the intervention and in the follow-up period one month after the end of the intervention. Method of measurement: Beck Depression Inventory-II.</sec_outcome>
      <sec_outcome>Cognition level. Timepoint: Before the intervention, after the end of the intervention and in the follow-up period one month after the end of the intervention. Method of measurement: Mini Mental Status Examination.</sec_outcome>
      <sec_outcome>Social Support. Timepoint: Before the intervention, after the end of the intervention and in the follow-up period one month after the end of the intervention. Method of measurement: Social Support Scale.</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>Iran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-03-14</approval_date>
        <contact_name>Iran university of medical sciences and health services</contact_name>
        <contact_address>Iran University of Medical Sciences., Shahid Hemmat highway, Tehran, Iran Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
