Depressive SymptomsNCT06018974
Digital Gaming Intervention for Older People in Long-term Care
A study testing Yetitablet gaming in people with Depressive Symptoms and Aging, run by University of Oulu at 1 site in Finland.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Depressive Symptoms, Aging, Loneliness
- What is being tested?
- Yetitablet gaming
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteFinland
- Study dates
- 13 Sep 2023to 11 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Digital Gaming Intervention With Yetitablet for Older Peoples' Functioning and Activity in Long-term Care Environment - Quasi-experimental Study
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.
Read the 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.
- Conditions
- Depressive Symptoms, Aging, Loneliness, Sedentary Behavior, Social Isolation, Physical Inactivity
- Being tested
- Yetitablet gaming
- Keywords
- aging, digital games, long-term care, older people, physical functioning, psychological functioning, social functioning, physical activity
- Medical subject headings
- Depression, Sedentary Behavior, Social Isolation, Social Adjustment, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Yetitablet gamingDevice
Playing digital games like bowling, memory games, coordination games ect. with the Yetitablet.
| Study group | Role | What they receive |
|---|---|---|
| Yetitablet group | Experimental | 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. Receives: Device: Yetitablet gaming |
| Control group | No intervention | Participants in control group will continue their normal daily activities in their home facility. No intervention is provided to control group (passive control group). |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Baseline and week 12
Secondary outcomes (5)
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).
Measured: Baseline and week 12
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
Measured: 13 weeks
Change in mood before and after every gaming session
Change in mean face scale scores (range 1-5, higher scores indicate better mood).
Measured: Every gaming session during three month long intervention
Change from baseline in hand grip strength at week 12
Change in hand grip strength in both hands measured with dynamometer
Measured: Baseline and week 12
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).
Measured: Baseline and week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2023
- Study start13 Sep 2023
- Primary completion11 Mar 2024
- Study completion11 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Depressive SymptomsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oulu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Satu Elo, PhD, Study director, Oulu University of Applied Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06018974
- Sponsor's protocol ID
- 49/2021
- Status last verified
- Jun 2024
- First submitted
- 9 Aug 2023
- Last updated
- 18 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 27810849de 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.
PubMed 30994779van 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.
PubMed 29689716
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Digital Gaming Intervention With Yetitablet for Older Peoples' Functioning and Activity in Long-term Care Environment - Quasi-experimental Study
- ClinicalTrials.gov ID
- NCT06018974
- Acronym / sponsor ID
- 49/2021
- Conditions
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- University of OuluUniversity, hospital or other
- Study start
- 13 Sep 2023 (actual)
- Primary completion
- 11 Mar 2024 (actual)
- Study completion
- 11 Mar 2024 (actual)
- First posted
- 31 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Yetitablet group | Experimental | Device: Yetitablet gamingOlder 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. |
| Control group | No intervention | –Participants in control group will continue their normal daily activities in their home facility. No intervention is provided to control group (passive control group). |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Yetitablet gamingPlaying digital games like bowling, memory games, coordination games ect. with the Yetitablet. | Device | Yetitablet group |
Primary outcome
Change from baseline in the Timed Up and Go test (TUG) at week 12
Time frame: Baseline and week 12
Change in mean scores on the Timed-up-and-Go test (Completion time in seconds, faster performance indicate better functioning).
5 secondary outcomes
Change from baseline in the Revised Index for Social Engagement (RISE) at week 12
Time frame: Baseline and week 12
Change from baseline in weekly time spent in light to vigorous physical activity
Time frame: 13 weeks
Change in mood before and after every gaming session
Time frame: Every gaming session during three month long intervention
Change from baseline in hand grip strength at week 12
Time frame: Baseline and week 12
Change from baseline in the Short Physical Performance Battery (SPPB) at week 12
Time frame: Baseline and week 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2024.
- Background: PubMed 27810849Jantunen 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.
- Background: PubMed 30994779de 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.
- Background: PubMed 29689716van 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Satu Elo, PhD study director
Oulu University of Applied Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Yetitablet gaming in people with Depressive Symptoms and Aging, run by University of Oulu at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in the Timed Up and Go test (TUG) at week 12 (time frame: Baseline and week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06018974, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2024.