<?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>IRCT2016122731602N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2017-06-21</date_registration>
      <primary_sponsor>Vice Chancellor for research of University of Social Welfare and Rehabilitation Sciences</primary_sponsor>
      <public_title>The efficacy of cognitive training intervention on the quality of life of older people</public_title>
      <acronym></acronym>
      <scientific_title>The impact of computer-based cognitive training intervention on the quality of life among elderly people: A randomized clinical trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-06-05</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>52</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/24829</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Other design features: In this study, the stratified design randomization will be used. Considering of depression(y/n) and educational status(diploma/academic education) as a dual- state variables, we will design 4 different randomization tables and samples will allocated into intervention and control group based on these variables. Finally data of this tables will be pooling, so we could control the effect of confounder variables, Randomization description: Participants were assigned to two groups using Balance blocked randomization, 26 in the intervention and 26 in the control group. Educational level and depression were considered as two potential confounding variables by considering existing evidence .Thus, a stratified randomized design was implemented to control the potentially confounding effect of these two binaries. Four randomizing sequences were used (the combination of depression and low educational level, depression and high educational level, high educational level without depression and low educational level without depression) and the participants were divided  in either the intervention or control group based on this different strata.  Finally pulled data was analyzed, Blinding description: According to the nature of the intervention, the participants could not be blinded in the process of intervention, so the person who analyzed data was blinded to the allocated into the intervention or control groups.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Age-related cognitive decline.</hc_freetext>
      <i_freetext>Intervention group: In Intervention group, after an evaluation session by assessing with cognitive function and quality of life instruments, participants are trained by ARAM app through 10 45-minute sessions, 2 times per week. Then they will be reassessed in the 12th session. Attentive rehabilitation of attention and memory (ARAM) is a software application that is a part of Neurocognitive Attentive Training Intervention as cognitive rehabilitation intervention. These tasks have different kinds of task in which the level of difficulty are graded and increased based on responses. Grading is based on the number of flanker stimuli, velocity of presented stimuli, number of goal stimuli and changing task rule..</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 there is no more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Leila Kazazi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Koodakyar avenue, Daneshjou Blvd, Evin</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1985713834</zip>
        <telephone>+98 21 2641 6984</telephone>
        <email>Le.kazazi@Uswr.ac.ir</email>
        <affiliation>University of Social Welfare and Rehabilitation Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mahshid Froughan</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Koodakyar avenue, Daneshjou Blvd, Evin, University of Social Welfare and Rehabilitation Sciences, Gerontology department</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1985713834</zip>
        <telephone>+98 21 2218 0004</telephone>
        <email>m_froughan@yahoo.com</email>
        <affiliation>University of Social Welfare and Rehabilitation Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Eligible participants were older adults aged 60 years and above.
Eligible participants were elderly who were able to communicate in Persian
Older adults required at least four years of education to respond the items on the Mini Mental State Examination (MMSE) test.
Eligible participants achieved a MMSE score ˃21 and a clock drawing test score ≥ 4.</inclusion_criteria>
      <agemin>60 years</agemin>
      <agemax>100 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>The diagnoses of a disease which could lead to extreme cognitive or functional decline, such as a stroke in the previous 12 months or end stage cancer
Individuals with dementia and Parkinson disease
Individuals with uncorrected visual or auditory impairment.
Individuals with subjective complaints of memory impairment</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>R41.8</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Other and unspecified symptoms and signs involving cognitive functions and awareness</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: In Intervention group, after an evaluation session by assessing with cognitive function and quality of life instruments, participants are trained by ARAM app through 10 45-minute sessions, 2 times per week. Then they will be reassessed in the 12th session. Attentive rehabilitation of attention and memory (ARAM) is a software application that is a part of Neurocognitive Attentive Training Intervention as cognitive rehabilitation intervention. These tasks have different kinds of task in which the level of difficulty are graded and increased based on responses. Grading is based on the number of flanker stimuli, velocity of presented stimuli, number of goal stimuli and changing task rule.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Quality of life. Timepoint: Before intervention and immediately after intervention and 3 months later. Method of measurement: Quality of life questionnaire (SF- 36).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Cognitive function. Timepoint: June 5st to July 21th 2017. Method of measurement: It was measured basically by the Iranian version of MMSE . The specific domain of the cognitive function was assessed by Wisconsin card sorting test, the Stroop test, the N back test and the go/no-go test.</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 of University of Social Welfare and Rehabilitation Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2016-08-10</approval_date>
        <contact_name>Ethics committee of University of Social Welfare and Rehabilitation Sciences</contact_name>
        <contact_address>Koodakyar de, Daneshjou Blvd, Evin Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
