<?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>IRCT201211101599N21</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2013-05-12</date_registration>
      <primary_sponsor>Vice chancellor for Research, Tehran University of Medical Sciences</primary_sponsor>
      <public_title>Improving adherence to therapeutic regimen in hemodialysis patients</public_title>
      <acronym></acronym>
      <scientific_title>The effect of cognitive-behavioral intervention on adherence to therapeutic   regimen and remove of related barriers in hemodialysis patients</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2013-05-30</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>70</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/1025</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: Two hospitals in Lar and Lamerd will be randomly assigned to the cognitive - behavioral intervention and control groups. These hospitals have equal aspects for hemodialysis and have similar nursing performance. 70 hemodialysis patients who will be admitted in hemodialysis wards of Lar and Lamerd hospitals will be participated in this study by convenience sampling.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Chronic renal disease.</hc_freetext>
      <i_freetext>Intervention 1: Cognitive-behavioral intervention consist of six steps: Step 1: Identifying the problem. In This step, Knowledge, belief, and the barrier to self-care will be determined by person-to-person interviews. Step 2: Creating confidence and commitment. In This step, the patient and the researcher will be signed a contract to begin working on a particular behavior change after face-to-face counseling. Step 3: Increasing awareness of behavior. This step leads to increase in the patient’s awareness of his or her behavior patterns through self-monitoring. The subjects were asked to keep a diary of adherence every day until the next consultation. Step 4: Developing and implementing the action plan. Based on the subject’s behavior, statements in the diary of adherence, a short-term action plan (On an individual basis), will be designed by researcher. Step 5: Evaluating the plan is designed. Impact on behavior change plan will be evaluated. If the subject failed, a new plan that can be achieved will be designed. Step 6: Maintain the desired behavior change to prevent undesirable behavior. The purpose of this step is to maintain and reinforce desired behaviors through motivational phrases. Intervention 2: Control group with no intervention adherence rates and barriers to adherence to treatment is evaluated before and 3 months after.</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>Sookhak Fatemeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Tohied Sq. Nosrat St. Nursing and Midwifery School.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 21 6105 4402</telephone>
        <email>Sookhakfatemeh@yahoo.com</email>
        <affiliation>Nursing and Midwifery College</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mitra Zolfaghari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Virtual School of Tehran University of  Medical Sciences.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 21 8896 9594</telephone>
        <email>zolfaghm@tums.ac.ir</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: 20-60 years old hemodialysis patients  who are on hemodialysis for at least one year 2 or 3 times a week, each session lasting 4-3 hours. Hemodialysis should be able to read and write in research subjects and Score  less than 50 on adherence to treatment. Exclusion criteria: Not willing to continue  participating in the  study .Not attending  any of the educational intervention</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>N18.5</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Chronic uremia</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Cognitive-behavioral intervention consist of six steps: Step 1: Identifying the problem. In This step, Knowledge, belief, and the barrier to self-care will be determined by person-to-person interviews. Step 2: Creating confidence and commitment. In This step, the patient and the researcher will be signed a contract to begin working on a particular behavior change after face-to-face counseling. Step 3: Increasing awareness of behavior. This step leads to increase in the patient’s awareness of his or her behavior patterns through self-monitoring. The subjects were asked to keep a diary of adherence every day until the next consultation. Step 4: Developing and implementing the action plan. Based on the subject’s behavior, statements in the diary of adherence, a short-term action plan (On an individual basis), will be designed by researcher. Step 5: Evaluating the plan is designed. Impact on behavior change plan will be evaluated. If the subject failed, a new plan that can be achieved will be designed. Step 6: Maintain the desired behavior change to prevent undesirable behavior. The purpose of this step is to maintain and reinforce desired behaviors through motivational phrases.</i_keyword>
      <i_keyword>Control group with no intervention adherence rates and barriers to adherence to treatment is evaluated before and 3 months after</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Adherence to therapeutic regimen. Timepoint: Before the intervention, and three months after intervention. Method of measurement: A researcher-made questionnaire with likert scale.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Barriers of adherence to therapeutic regimen. Timepoint: Before the intervention, and three months after intervention. Method of measurement: A researcher-made questionnaire with likert 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>Vice chancellor for Research, Tehran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2013-01-07</approval_date>
        <contact_name>Ethic Committee-Tehran University of Medical Sciences</contact_name>
        <contact_address>Ghods St. Keshavarz Blv. Central building of Tehran University of Medical Sciences, 6th floor Tehran  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
