<?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>IRCT20210106049950N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-05-31</date_registration>
      <primary_sponsor>Tehran University of Medical Sciences</primary_sponsor>
      <public_title>Effectiveness of Home Modification on Falling, Occupational Performance and Life Habits in Elderly with Dementia</public_title>
      <acronym></acronym>
      <scientific_title>Effectiveness of Home Modification on Falling, Occupational Performance and Life Habits in Elderly with Dementia</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-01-12</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>40</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/53554</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: p, Randomization description: Participants will be allocated into two groups using a permuted balanced block randomization method with the size of blocks 4 and 6. The random sequence will be generated by an epidemiologist by running an online program in sealed envelope website (https://www.sealedenvelope.com/). Concealment is also guaranteed due to the use of permuted balanced block randomization method, Blinding description: Only the statistical analyzer is blind and does not know about the assignment of individuals to groups and the data is provided to the analyzer in encrypted form.</study_design>
      <phase>N/A</phase>
      <hc_freetext>dementia.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: home modification.     First, the demographic information questionnaire, the Canadian Occupational Performance Measure, and the Life Habits Questionnaire are completed for the participant. The home environment is then evaluated with Home Falls and Accidents Screening Tool. Then, for different environments of the house (kitchen, bathroom, stairs, ...) modification actions will be implemented if necessary. (Modifications actions for the intervention group include the following: 1. Modification for access, which includes; Doors, locks, handles, barriers, corridors, ramps, and bathroom modifications. 2. Check the edges of the stairs inside and outside the house 3. Check the condition of the floor coverings inside and outside the house, bathroom, and toilet 4. Check the floor surfaces for slipperiness 5. Check the floor coverings (carpet, rug, carpet, and padding) 6. Check the light access to the bedside lamp from bed 7. Check the brightness of outdoor paths, stairs, and entrances at night, which have enough light 8. Check the brightness of outdoor and indoor lights (Rooms, reception, hallway, bathroom, toilet, and kitchen) 9. Check the existence of non-slip floors for safe entry into the bathroom and bathtub and toilet 10. Check the installation of handles in the bathroom and next to the bathtub and shower 11. Check the direction Easy and safe access to the kitchen utensils 12. Check the railings of the inside and outside stairs of house 13. Check the safe access for pet care 14. Check the use of slippers and shoes that are perfectly suitable for the person's feet 15. Eliminate clutter and Indoor crowds 16. Check the required assistive devices 17. Check the arrangement of furniture and appliances 18. Use visual and auditory tips 19. Provide solutions to simplify activities). Intervention 2: Control group: control.</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 A decision will be made at the end of the study.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Hamed Setoudeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 52, Vesal Shirazi Ave., Keshavarz, Blvd., Tehran University Town</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1417743855</zip>
        <telephone>+98 74 3333 6497</telephone>
        <email>h_setoudeh@razi.tums.ac.ir</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Hamed Setoudeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 52, Vesal Shirazi Ave., Keshavarz, Blvd., Tehran University Town</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1417743855</zip>
        <telephone>+98 74 3333 6497</telephone>
        <email>h_setoudeh@razi.tums.ac.ir</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Elderly people 65 and older have symptoms of dementia and have been approved by a neurologist.
The level of dementia in the elderly is mild; (Clinical Dementia Rating (CDR) test score is 4.5 to 9)
Elderly with dementia, stay at home.</inclusion_criteria>
      <agemin>65 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>The elderly with dementia lives in a nursing home or is bedridden.
The elderly have a history of other neurological problems, orthopedic and rheumatological disorders, acute psychiatric disorders based on the information in the medical record.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F01</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Vascular dementia</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: home modification.     First, the demographic information questionnaire, the Canadian Occupational Performance Measure, and the Life Habits Questionnaire are completed for the participant. The home environment is then evaluated with Home Falls and Accidents Screening Tool. Then, for different environments of the house (kitchen, bathroom, stairs, ...) modification actions will be implemented if necessary. (Modifications actions for the intervention group include the following: 1. Modification for access, which includes; Doors, locks, handles, barriers, corridors, ramps, and bathroom modifications. 2. Check the edges of the stairs inside and outside the house 3. Check the condition of the floor coverings inside and outside the house, bathroom, and toilet 4. Check the floor surfaces for slipperiness 5. Check the floor coverings (carpet, rug, carpet, and padding) 6. Check the light access to the bedside lamp from bed 7. Check the brightness of outdoor paths, stairs, and entrances at night, which have enough light 8. Check the brightness of outdoor and indoor lights (Rooms, reception, hallway, bathroom, toilet, and kitchen) 9. Check the existence of non-slip floors for safe entry into the bathroom and bathtub and toilet 10. Check the installation of handles in the bathroom and next to the bathtub and shower 11. Check the direction Easy and safe access to the kitchen utensils 12. Check the railings of the inside and outside stairs of house 13. Check the safe access for pet care 14. Check the use of slippers and shoes that are perfectly suitable for the person's feet 15. Eliminate clutter and Indoor crowds 16. Check the required assistive devices 17. Check the arrangement of furniture and appliances 18. Use visual and auditory tips 19. Provide solutions to simplify activities)</i_keyword>
      <i_keyword>Control group: control</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Fall. Timepoint: before intervention, 30, 60 and 90 days after intervention. Method of measurement: Home Falls and Accidents Screening Tool (HOME FAST).</prim_outcome>
      <prim_outcome>Occupational Performance. Timepoint: before intervention and 90 days after intervention. Method of measurement: Canadian Occupational Performance Measure (COPM).</prim_outcome>
      <prim_outcome>Life Habits. Timepoint: before intervention and 90 days after intervention. Method of measurement: Life Habits questionnaire (Life-H).</prim_outcome>
      <prim_outcome>Home Modification. Timepoint: before the intervention and 30, 60 and 90 days after the intervention. Method of measurement: Home Falls and Accidents Screening Tool (HOME FAST).</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>2020-12-27</approval_date>
        <contact_name>Ethics committee of Tehran University of Medical Sciences</contact_name>
        <contact_address>No. 52, Vesal Shirazi Ave., Keshavarz, Blvd., Tehran University Town Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
