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Digital Gaming Intervention for Older People in Long-term Care

Primary Purpose

Depressive Symptoms, Aging, Loneliness

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Yetitablet gaming
Sponsored by
University of Oulu
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depressive Symptoms focused on measuring aging, digital games, long-term care, older people, physical functioning, psychological functioning, social functioning, physical activity

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: lives in a long-term care facility for older people participating in the study has sufficient cognitive ability to understand the purpose of the study is able to walk (with or without walking aid) the distance required by physical functioning tests (10m) no illness restricting light exercise no serious, acute illness sufficient cognitive skills to understand game instructions sufficient functionality of the upper limbs to use the touch screen Exclusion Criteria: unable to move independently even with walking aid severe memory disorder or other acute illness unable to understand game instructions, or able to concentrate on playing games for the required time too weak vision to play games unable to use upper limbs to play simultaneously receiving some other treatment that differs from usual treatment

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Yetitablet group

    Control group

    Arm 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.

    Participants in control group will continue their normal daily activities in their home facility. No intervention is provided to control group (passive control group).

    Outcomes

    Primary Outcome Measures

    Change from baseline in the Timed Up and Go test (TUG) at week 12
    Change in mean scores on the Timed-up-and-Go test (Completion time in seconds, faster performance indicate better functioning).

    Secondary Outcome Measures

    Change from baseline in the Revised Index for Social Engagement (RISE) at week 12
    Change in mean RISE points (range 0-6, higher points indicate more social engagement).
    Change from baseline in weekly time spent in light to vigorous physical activity
    Physical activity (weekly time spent in light to vigorous physical activity) measured with wrist-worn physical activity monitor continuously over the 3-month trial
    Change in mood before and after every gaming session
    Change in mean face scale scores (range 1-5, higher scores indicate better mood).
    Change from baseline in hand grip strength at week 12
    Change in hand grip strength in both hands measured with dynamometer
    Change from baseline in the Short Physical Performance Battery (SPPB) at week 12
    Change in mean scores on the SPPB test (higher scores indicate better functioning).

    Full Information

    First Posted
    August 9, 2023
    Last Updated
    August 30, 2023
    Sponsor
    University of Oulu
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06018974
    Brief Title
    Digital Gaming Intervention for Older People in Long-term Care
    Official Title
    Effectiveness of Digital Gaming Intervention With Yetitablet for Older Peoples' Functioning and Activity in Long-term Care Environment - Quasi-experimental Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 2023 (Anticipated)
    Primary Completion Date
    December 2023 (Anticipated)
    Study Completion Date
    December 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University of Oulu

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    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.
    Detailed Description
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Depressive Symptoms, Aging, Loneliness, Sedentary Behavior, Social Isolation, Physical Inactivity
    Keywords
    aging, digital games, long-term care, older people, physical functioning, psychological functioning, social functioning, physical activity

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    70 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Yetitablet group
    Arm Type
    Experimental
    Arm 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 Title
    Control group
    Arm Type
    No Intervention
    Arm 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(s)
    Yetitablet gaming
    Intervention Description
    Playing digital games like bowling, memory games, coordination games ect. with the Yetitablet.
    Primary Outcome Measure Information:
    Title
    Change from baseline in the Timed Up and Go test (TUG) at week 12
    Description
    Change in mean scores on the Timed-up-and-Go test (Completion time in seconds, faster performance indicate better functioning).
    Time Frame
    Baseline and week 12
    Secondary Outcome Measure Information:
    Title
    Change from baseline in the Revised Index for Social Engagement (RISE) at week 12
    Description
    Change in mean RISE points (range 0-6, higher points indicate more social engagement).
    Time Frame
    Baseline and week 12
    Title
    Change from baseline in weekly time spent in light to vigorous physical activity
    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
    Time Frame
    13 weeks
    Title
    Change in mood before and after every gaming session
    Description
    Change in mean face scale scores (range 1-5, higher scores indicate better mood).
    Time Frame
    Every gaming session during three month long intervention
    Title
    Change from baseline in hand grip strength at week 12
    Description
    Change in hand grip strength in both hands measured with dynamometer
    Time Frame
    Baseline and week 12
    Title
    Change from baseline in the Short Physical Performance Battery (SPPB) at week 12
    Description
    Change in mean scores on the SPPB test (higher scores indicate better functioning).
    Time Frame
    Baseline and week 12

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: lives in a long-term care facility for older people participating in the study has sufficient cognitive ability to understand the purpose of the study is able to walk (with or without walking aid) the distance required by physical functioning tests (10m) no illness restricting light exercise no serious, acute illness sufficient cognitive skills to understand game instructions sufficient functionality of the upper limbs to use the touch screen Exclusion Criteria: unable to move independently even with walking aid severe memory disorder or other acute illness unable to understand game instructions, or able to concentrate on playing games for the required time too weak vision to play games unable to use upper limbs to play simultaneously receiving some other treatment that differs from usual treatment
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Saara Kukkohovi, MSc
    Phone
    +358504420666
    Email
    saara.kukkohovi@oulu.fi
    First Name & Middle Initial & Last Name or Official Title & Degree
    Satu Elo, PhD
    Email
    satu.elo@oamk.fi
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Satu Elo, PhD
    Organizational Affiliation
    Oulu University of Applied Sciences
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    27810849
    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.
    Results Reference
    background
    PubMed Identifier
    30994779
    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.
    Results Reference
    background
    PubMed Identifier
    29689716
    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.
    Results Reference
    background

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    Digital Gaming Intervention for Older People in Long-term Care

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