xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT06018974</url>
    </required_header>
    <id_info>
      <org_study_id>49/2021</org_study_id>
      <nct_id>NCT06018974</nct_id>
    </id_info>
    <brief_title>Digital Gaming Intervention for Older People in Long-term Care</brief_title>
    <official_title>Effectiveness of Digital Gaming Intervention With Yetitablet for Older Peoples' Functioning and Activity in Long-term Care Environment - Quasi-experimental Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Oulu</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University of Oulu</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Older people in long-term care (LTC) are often less physically active than their&#xD;
        community-dwelling peers. Low physical activity level is associated with more symptoms of&#xD;
        anxiety and depression as well as with lower physical performance. This weakens coping with&#xD;
        daily activities and increases the care costs. Earlier research have found that playing&#xD;
        digital games that require physical activity affects positively functioning of older people.&#xD;
        Playing can increase physical activity, improve balance and walking speed, lift the mood and&#xD;
        create opportunities for social interaction. The effects of digital gaming, especially on&#xD;
        objectively measured physical activity and social functioning, are still unclear.&#xD;
  &#xD;
        The aim of this study is to evaluate effectiveness of digital gaming intervention with&#xD;
        Yetitablet to physical, psychological and social functioning and activity of older people in&#xD;
        long-term care environment.&#xD;
  &#xD;
        This study investigates the effectiveness of the Yetitablet in improving the functioning of&#xD;
        older people. Yetitablet is an assistive technology device developed for special groups.&#xD;
        Yetitablet is a large interactive touchscreen tablet with 55&quot; screen and with Android&#xD;
        operating system and it includes numerous applications. Yetitablet has mobile stand on&#xD;
        wheels, which allows the screen to be raised and lowered, as well as tilted as needed, all&#xD;
        the way to a desk position. Applications can be downloaded to the device from the Google Play&#xD;
        Store, and it also has its own game applications, such as darts, table hockey and memory&#xD;
        game. These games can be played individually or in group. There is no previous scientific&#xD;
        research on the effectiveness of the Yetitablet on the functioning and activity of older&#xD;
        people in long-term care settings.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Sample size calculation was completed based on an effect size of 0.3 (power = 0.80; α= 0.05).&#xD;
        Assuming a 25% attrition rate, a total of 70 residents will be recruited (35 people in a&#xD;
        control group and 35 people in the intervention group). Participants will be recruited from&#xD;
        LTC facilities for older people in the region of Oulu in northern Finland. Facilities will be&#xD;
        selected by purposeful sampling. Participants will be selected by personnel of the facilities&#xD;
        purposefully based on the inclusion criteria.&#xD;
  &#xD;
        After being informed about the study all suitable residents willing to participate in this&#xD;
        study will undergo baseline functional testing on week 0. Same functional measurements will&#xD;
        be conducted after three month intervention period. Baseline physical activity will be&#xD;
        measured by activity tracker during one week before intervention and during the intervention&#xD;
        (3 months). In addition, approximately 10-15 LTC facility personnel will be recruited for&#xD;
        semi-structured group interviews to understand more of the effects of Yetitablet to&#xD;
        psychological and social functioning as well as social activity of LTC residents. The&#xD;
        interviews will also clarify the staff's experiences of using the Yetitablet and its&#xD;
        suitability for the everyday life of the facility.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">December 2023</completion_date>
    <primary_completion_date type="Anticipated">December 2023</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Non-Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Change from baseline in the Timed Up and Go test (TUG) at week 12</measure>
      <time_frame>Baseline and week 12</time_frame>
      <description>Change in mean scores on the Timed-up-and-Go test (Completion time in seconds, faster performance indicate better functioning).</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Change from baseline in the Revised Index for Social Engagement (RISE) at week 12</measure>
      <time_frame>Baseline and week 12</time_frame>
      <description>Change in mean RISE points (range 0-6, higher points indicate more social engagement).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change from baseline in weekly time spent in light to vigorous physical activity</measure>
      <time_frame>13 weeks</time_frame>
      <description>Physical activity (weekly time spent in light to vigorous physical activity) measured with wrist-worn physical activity monitor continuously over the 3-month trial</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in mood before and after every gaming session</measure>
      <time_frame>Every gaming session during three month long intervention</time_frame>
      <description>Change in mean face scale scores (range 1-5, higher scores indicate better mood).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change from baseline in hand grip strength at week 12</measure>
      <time_frame>Baseline and week 12</time_frame>
      <description>Change in hand grip strength in both hands measured with dynamometer</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change from baseline in the Short Physical Performance Battery (SPPB) at week 12</measure>
      <time_frame>Baseline and week 12</time_frame>
      <description>Change in mean scores on the SPPB test (higher scores indicate better functioning).</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">70</enrollment>
    <condition>Depressive Symptoms</condition>
    <condition>Aging</condition>
    <condition>Loneliness</condition>
    <condition>Sedentary Behavior</condition>
    <condition>Social Isolation</condition>
    <condition>Physical Inactivity</condition>
    <arm_group>
      <arm_group_label>Yetitablet group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Older adults in the experimental group will participate in a 12-week, 3 times per week, 30-60 minutes per session (recommendation) gaming session with Yetitablet in their home facility. Games will be played in group of 3-5 people with participants taking turns. Gaming sessions are supervised by research assistant or facility personnel.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control group</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>Participants in control group will continue their normal daily activities in their home facility. No intervention is provided to control group (passive control group).</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Yetitablet gaming</intervention_name>
      <description>Playing digital games like bowling, memory games, coordination games ect. with the Yetitablet.</description>
      <arm_group_label>Yetitablet group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  lives in a long-term care facility for older people participating in the study&#xD;
  &#xD;
            -  has sufficient cognitive ability to understand the purpose of the study&#xD;
  &#xD;
            -  is able to walk (with or without walking aid) the distance required by physical&#xD;
               functioning tests (10m)&#xD;
  &#xD;
            -  no illness restricting light exercise&#xD;
  &#xD;
            -  no serious, acute illness&#xD;
  &#xD;
            -  sufficient cognitive skills to understand game instructions&#xD;
  &#xD;
            -  sufficient functionality of the upper limbs to use the touch screen&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  unable to move independently even with walking aid&#xD;
  &#xD;
            -  severe memory disorder or other acute illness&#xD;
  &#xD;
            -  unable to understand game instructions, or able to concentrate on playing games for&#xD;
               the required time&#xD;
  &#xD;
            -  too weak vision to play games&#xD;
  &#xD;
            -  unable to use upper limbs to play&#xD;
  &#xD;
            -  simultaneously receiving some other treatment that differs from usual treatment&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>60 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Satu Elo, PhD</last_name>
      <role>Study Director</role>
      <affiliation>Oulu University of Applied Sciences</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Saara Kukkohovi, MSc</last_name>
      <phone>+358504420666</phone>
      <email>saara.kukkohovi@oulu.fi</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Satu Elo, PhD</last_name>
      <email>satu.elo@oamk.fi</email>
    </overall_contact_backup>
    <reference>
      <citation>Jantunen H, Wasenius N, Salonen MK, Perala MM, Osmond C, Kautiainen H, Simonen M, Pohjolainen P, Kajantie E, Rantanen T, von Bonsdorff MB, Eriksson JG. Objectively measured physical activity and physical performance in old age. Age Ageing. 2017 Mar 1;46(2):232-237. doi: 10.1093/ageing/afw194.</citation>
      <PMID>27810849</PMID>
    </reference>
    <reference>
      <citation>de Oliveira LDSSCB, Souza EC, Rodrigues RAS, Fett CA, Piva AB. The effects of physical activity on anxiety, depression, and quality of life in elderly people living in the community. Trends Psychiatry Psychother. 2019 Jan-Mar;41(1):36-42. doi: 10.1590/2237-6089-2017-0129. Epub 2019 Feb 4.</citation>
      <PMID>30994779</PMID>
    </reference>
    <reference>
      <citation>van Santen J, Droes RM, Holstege M, Henkemans OB, van Rijn A, de Vries R, van Straten A, Meiland F. Effects of Exergaming in People with Dementia: Results of a Systematic Literature Review. J Alzheimers Dis. 2018;63(2):741-760. doi: 10.3233/JAD-170667.</citation>
      <PMID>29689716</PMID>
    </reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 9, 2023</study_first_submitted>
    <study_first_submitted_qc>August 30, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 31, 2023</study_first_posted>
    <last_update_submitted>August 30, 2023</last_update_submitted>
    <last_update_submitted_qc>August 30, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 31, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>aging</keyword>
    <keyword>digital games</keyword>
    <keyword>long-term care</keyword>
    <keyword>older people</keyword>
    <keyword>physical functioning</keyword>
    <keyword>psychological functioning</keyword>
    <keyword>social functioning</keyword>
    <keyword>physical activity</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Depression</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT06018974
  org study id: 49/2021
  nct id: NCT06018974
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  Older people in long-term care (LTC) are often less physically active than their
        community-dwelling peers. Low physical activity level is associated with more symptoms of
        anxiety and depression as well as with lower physical performance. This weakens coping with
        daily activities and increases the care costs. Earlier research have found that playing
        digital games that require physical activity affects positively functioning of older people.
        Playing can increase physical activity, improve balance and walking speed, lift the mood and
        create opportunities for social interaction. The effects of digital gaming, especially on
        objectively measured physical activity and social functioning, are still unclear.
  
        The aim of this study is to evaluate effectiveness of digital gaming intervention with
        Yetitablet to physical, psychological and social functioning and activity of older people in
        long-term care environment.
  
        This study investigates the effectiveness of the Yetitablet in improving the functioning of
        older people. Yetitablet is an assistive technology device developed for special groups.
        Yetitablet is a large interactive touchscreen tablet with 55" screen and with Android
        operating system and it includes numerous applications. Yetitablet has mobile stand on
        wheels, which allows the screen to be raised and lowered, as well as tilted as needed, all
        the way to a desk position. Applications can be downloaded to the device from the Google Play
        Store, and it also has its own game applications, such as darts, table hockey and memory
        game. These games can be played individually or in group. There is no previous scientific
        research on the effectiveness of the Yetitablet on the functioning and activity of older
        people in long-term care settings.
  Sample size calculation was completed based on an effect size of 0.3 (power = 0.80; α= 0.05).
        Assuming a 25% attrition rate, a total of 70 residents will be recruited (35 people in a
        control group and 35 people in the intervention group). Participants will be recruited from
        LTC facilities for older people in the region of Oulu in northern Finland. Facilities will be
        selected by purposeful sampling. Participants will be selected by personnel of the facilities
        purposefully based on the inclusion criteria.
  
        After being informed about the study all suitable residents willing to participate in this
        study will undergo baseline functional testing on week 0. Same functional measurements will
        be conducted after three month intervention period. Baseline physical activity will be
        measured by activity tracker during one week before intervention and during the intervention
        (3 months). In addition, approximately 10-15 LTC facility personnel will be recruited for
        semi-structured group interviews to understand more of the effects of Yetitablet to
        psychological and social functioning as well as social activity of LTC residents. The
        interviews will also clarify the staff's experiences of using the Yetitablet and its
        suitability for the everyday life of the facility.
  allocation: Non-Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Change from baseline in the Timed Up and Go test (TUG) at week 12
  time frame: Baseline and week 12
  description: Change in mean scores on the Timed-up-and-Go test (Completion time in seconds, faster performance indicate better functioning).
  measure: Change from baseline in the Revised Index for Social Engagement (RISE) at week 12
  time frame: Baseline and week 12
  description: Change in mean RISE points (range 0-6, higher points indicate more social engagement).
  measure: Change from baseline in weekly time spent in light to vigorous physical activity
  time frame: 13 weeks
  description: Physical activity (weekly time spent in light to vigorous physical activity) measured with wrist-worn physical activity monitor continuously over the 3-month trial
  measure: Change in mood before and after every gaming session
  time frame: Every gaming session during three month long intervention
  description: Change in mean face scale scores (range 1-5, higher scores indicate better mood).
  measure: Change from baseline in hand grip strength at week 12
  time frame: Baseline and week 12
  description: Change in hand grip strength in both hands measured with dynamometer
  measure: Change from baseline in the Short Physical Performance Battery (SPPB) at week 12
  time frame: Baseline and week 12
  description: Change in mean scores on the SPPB test (higher scores indicate better functioning).
  arm group label: Yetitablet group
  arm group type: Experimental
  description: Older adults in the experimental group will participate in a 12-week, 3 times per week, 30-60 minutes per session (recommendation) gaming session with Yetitablet in their home facility. Games will be played in group of 3-5 people with participants taking turns. Gaming sessions are supervised by research assistant or facility personnel.
  arm group label: Control group
  arm group type: No Intervention
  description: Participants in control group will continue their normal daily activities in their home facility. No intervention is provided to control group (passive control group).
  intervention type: Device
  intervention name: Yetitablet gaming
  description: Playing digital games like bowling, memory games, coordination games ect. with the Yetitablet.
  arm group label: Yetitablet group
  criteria: 
  gender: All
  minimum age: 60 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Satu Elo, PhD
  role: Study Director
  affiliation: Oulu University of Applied Sciences
  last name: Saara Kukkohovi, MSc
  phone: +358504420666
  email: saara.kukkohovi@oulu.fi
  last name: Satu Elo, PhD
  email: satu.elo@oamk.fi
  citation: Jantunen H, Wasenius N, Salonen MK, Perala MM, Osmond C, Kautiainen H, Simonen M, Pohjolainen P, Kajantie E, Rantanen T, von Bonsdorff MB, Eriksson JG. Objectively measured physical activity and physical performance in old age. Age Ageing. 2017 Mar 1;46(2):232-237. doi: 10.1093/ageing/afw194.
  PMID: 27810849
  citation: de Oliveira LDSSCB, Souza EC, Rodrigues RAS, Fett CA, Piva AB. The effects of physical activity on anxiety, depression, and quality of life in elderly people living in the community. Trends Psychiatry Psychother. 2019 Jan-Mar;41(1):36-42. doi: 10.1590/2237-6089-2017-0129. Epub 2019 Feb 4.
  PMID: 30994779
  citation: van Santen J, Droes RM, Holstege M, Henkemans OB, van Rijn A, de Vries R, van Straten A, Meiland F. Effects of Exergaming in People with Dementia: Results of a Systematic Literature Review. J Alzheimers Dis. 2018;63(2):741-760. doi: 10.3233/JAD-170667.
  PMID: 29689716
  responsible party type: Sponsor
  mesh term: Depression
  sharing ipd: No