<?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>IRCT201202128978N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2012-03-18</date_registration>
      <primary_sponsor>Tehran university of Medical Sciences</primary_sponsor>
      <public_title>The effect of using family-based care program on adherence to treatment regimen in stroke patients</public_title>
      <acronym></acronym>
      <scientific_title>Effect of family-based care program on adherence of  treatment regimen in patients with stroke</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2011-04-17</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/9426</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Brain stroke.</hc_freetext>
      <i_freetext>Intervention 1: Family-centered care plan has four parts :   Assessment, family education based onpatient care  need , Telephone follow-up care after discharge,Coordination and referrals between family and health care providers in related to caring of patient. &#13;
48 hours after patient admission, the questionnaire of demographic data for primary caregivers and patient filled by the researcher.&#13;
in  needs assessment stage, check list in three areas of assessment, rehabilitation, diet and medication regimen was completed.Educational content according to the need assessment, was prepared in three parts.&#13;
family education developed and implemented based on andragogy theory. family education were conducted on 3 consecutive days in the hospital.Reassessment was done in training.Illustrated educational booklet was given to the patient's primary caregiver.In the thelephon follow-up after discharge, Each week, call the family carer for educationa need and resolve care problems.in the referral stage, medical teams of each patient was identified and communication way with the treatment team, was foun and if necessary, appropriate reference  was introduced to family for solve the care problem.After two months after the intervention, the questioniare of adherence of therapeutic regimen was assessed via telephone. Intervention 2: Comparing groups within two months of research applications received routine hospital program. After two months , the questioniare of adherence of therapeutic regimen was filled via telephone.</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>Nahid Dehghan Nayeri</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of nursing and midwifery , Tohid sq. Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 21 6105 4313</telephone>
        <email>nahid.nayeri@gmail.comdehghann@tums.ac.ir</email>
        <affiliation>Tehran Univesity of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Nahid Dehghan Nayeri</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Nursing and Mdwifery, Tohid Sq, tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 21 6105 4313</telephone>
        <email>dehghann@tums.ac.irnahid.ayeri@gmail.com</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: patient with first stroke; Rankin Scale score of 4-5,Patients discharged to home after hospitalization; Patients stay at least 5 days in hospital;there is primary carer of  patients in the hospital for implementing of family centered carethe program; Primry care patients at least 4 days a week to take care of the patient,Home carer patients are literatur;we can contact with  primary carer of  patients. &#13;
 Exclusion criteria: changes in individual patient care; Putting the patient at the end stage of disease according to the doctor.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>I64</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Stroke, not specified as haemorrhage or infarction</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Other</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Family-centered care plan has four parts :   Assessment, family education based onpatient care  need , Telephone follow-up care after discharge,Coordination and referrals between family and health care providers in related to caring of patient. &#13;
48 hours after patient admission, the questionnaire of demographic data for primary caregivers and patient filled by the researcher.&#13;
in  needs assessment stage, check list in three areas of assessment, rehabilitation, diet and medication regimen was completed.Educational content according to the need assessment, was prepared in three parts.&#13;
family education developed and implemented based on andragogy theory. family education were conducted on 3 consecutive days in the hospital.Reassessment was done in training.Illustrated educational booklet was given to the patient's primary caregiver.In the thelephon follow-up after discharge, Each week, call the family carer for educationa need and resolve care problems.in the referral stage, medical teams of each patient was identified and communication way with the treatment team, was foun and if necessary, appropriate reference  was introduced to family for solve the care problem.After two months after the intervention, the questioniare of adherence of therapeutic regimen was assessed via telephone.</i_keyword>
      <i_keyword>Comparing groups within two months of research applications received routine hospital program. After two months , the questioniare of adherence of therapeutic regimen was filled via telephone.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Adherence to treatment regimen. Timepoint: 2 months after discharge. 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>Tehran university of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2011-04-17</approval_date>
        <contact_name>Tehran University of Medical Sciences</contact_name>
        <contact_address>School of nursing and midwifery , Tohid Sq. Tehran Tehran  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
