<?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>IRCT2016052828121N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2017-02-26</date_registration>
      <primary_sponsor>Vice Chancellor for Research, Kerman, University of Medical Sciences</primary_sponsor>
      <public_title>Effect of  information intervention in  care performance, burden, knowledge and  attitude of family caregivers of people with dementia</public_title>
      <acronym></acronym>
      <scientific_title>Surveying the effect of  a Web-based Health information intervention in  care performance, burden, knowledge and  attitude of family caregivers of people with dementia in Kerman and evaluation of their satisfaction</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2016-11-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>50</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/22882</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: In this study, the Stratified randomization method was used. By attempting to eliminate heterogeneity of the groups before random allocation by classifying two variables; age and the number  of  hours  in  day  caring for care recipient.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Condition 1: Dementia in Alzheimer disease. Condition 2: Vascular dementia. Condition 3: Dementia in other diseases classified elsewhere.</hc_freetext>
      <i_freetext>Intervention 1: Through designed websites  information mainly on the implications of this disease, its symptoms, behavioral changes, stress management for caregivers and how to take care  will be present during 2 months (12 sessions) and in forms of text, slides, pictures and video all information which approved by a neurologist. Intervention 2: The participants of control group received no intervention.</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:
the primary outcome measure only

When:
starting results 6 months after publication

To whom:
Patient and caregiver data will not be available for anybody

Conditions:
Only use the results of the study in future studies

Where to obtain:
email: s_salehi@kmu.ac.ir

How to obtain:
Undecided

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Simin Salehi Nejad</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 212, 2nd floor, Institute for Future Studies in Health, Kerman University of Medical Sciences, Haft Baghe Alavi Highway, Kerman, Iran</address>
        <city>Kerman</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>Iran</zip>
        <telephone>+98 34 3132 5418</telephone>
        <email>s_salehi@kmu.ac.ir</email>
        <affiliation>Kerman Medical Informatics Resaerch Center</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mohammad Aazami</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Management and Health Informatics, Kerman University of Medical Sciences, Haft Baghe Alavi Highway</address>
        <city>Kerman</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>Iran</zip>
        <telephone>+98 34 3132 5394</telephone>
        <email>mohammadaazami14@gmail.com</email>
        <affiliation>Kerman Faculty of Management and Health Informatics</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>nclusion criteria: consent to participate in research; caregiver is personally responsible for patient care (the care of his responsibility); internet access (at least twice a week); understanding and ability to work with Internet; interested in receiving information on this disease.
Exclusion criteria: unwillingness to continue to cooperate; escrow patient care to other people; patient death.</inclusion_criteria>
      <agemin>15 years</agemin>
      <agemax>90 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F00</hc_code>
      <hc_code>F01</hc_code>
      <hc_code>F02</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Alzheimer disease is a primary degenerative cerebral disease of unknown etiology with characteristic neuropathological and neurochemical features. The disorder is usually insidious in onset and develops slowly but steadily over a period of several years</hc_keyword>
      <hc_keyword>Vascular dementia is the result of infarction of the brain due to vascular disease, including hypertensive cerebrovascular disease. The infarcts are usually small but cumulative in their effect. Onset is usually in later life</hc_keyword>
      <hc_keyword>Cases of dementia due, or presumed to be due, to causes other than Alzheimer disease or cerebrovascular disease. Onset may be at any time in life, though rarely in old age</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Other</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Through designed websites  information mainly on the implications of this disease, its symptoms, behavioral changes, stress management for caregivers and how to take care  will be present during 2 months (12 sessions) and in forms of text, slides, pictures and video all information which approved by a neurologist.</i_keyword>
      <i_keyword>The participants of control group received no intervention.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Care burden. Timepoint: At the begining and 2 months after intervention. Method of measurement: Questionnaire.</prim_outcome>
      <prim_outcome>Care performance. Timepoint: At the begining and 2 months after intervention. Method of measurement: Questionnaire.</prim_outcome>
      <prim_outcome>Knowledge. Timepoint: At the begining and 2 months after intervention. Method of measurement: Questionnaire.</prim_outcome>
      <prim_outcome>Attitude. Timepoint: At the begining and 2 months after intervention. Method of measurement: Questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome></sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name>Medical Informatics Resaerch Center</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, Kerman, University of Medical Sciences</source_name>
      <source_name>Medical Informatics Resaerch Center</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2016-08-20</approval_date>
        <contact_name>Ethics committee of Kerman University of Medical Sciences</contact_name>
        <contact_address>Kerman University of Medical Sciences, Somayeh intersection, In front of the Besaat clinic, Kerman Kerman Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
