LonelinessNCT04733898
Social Health Games: The Use of Online Games to Decrease Loneliness in Older Adults
A study testing SamenSpelen.app and FijnSpelen.app in people with Loneliness, run by Radboud University Medical Center at 1 site in Netherlands.
Trial summary
This study examines whether social platform games are effective in expanding the social network and decreasing the experienced levels of loneliness in older adults. The newly developed social games will be compared to non-personal games and not playing games. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Loneliness
- What is being tested?
- SamenSpelen.app and FijnSpelen.app
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Apr 2021to 28 Mar 2022
- 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 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Being 65 years or older
- Have access to a smartphone with an internet connection
Who cannot join
- Visual or cognitive impairments that limit independent use of a mobile phone
- Not being fluent in the Dutch language
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Social Health Games: a Gamified Intervention to Decrease Loneliness in Older Adults - a Randomized Controlled Trial
This study examines whether social platform games are effective in expanding the social network and decreasing the experienced levels of loneliness in older adults. The newly developed social games will be compared to non-personal games and not playing games.
Read the detailed description
Rationale: loneliness and social isolation are an increasing problem in older adults with the aging of society. One option to foster social contact is through online games, which allow social interaction at a distance.
Objective: to investigate whether playing social online games has a beneficial effect on subjective loneliness and social network in older adults, compared with playing non-personal games and not playing games.
Study design: 3-arm randomized controlled trial.
Study population: A sample of 300 human volunteers aged 65 and over, who have access to a smartphone and an internet connection. The sample will be evenly distributed across the three groups.
Everybody else is allowed to use the gaming portal; they will form the pool of people that the participants can play with. This pool will be tracked within the gaming portal and posed some questions regarding their fellow players and their experiences loneliness. People aged under 16 can play but will not be tracked.
Intervention (if applicable): Three groups: (I) Intervention group, who will be given access to an app with the social games, and are encouraged to use this app as much as possible, (II) active control group, who will be given access to an app with non-personal games, and are encouraged to use this app as much as possible, (III) passive control group, who will be given access to an app with no games. The platform has a chatbot designed to take the questionnaires.
Comparison between groups (I+II) and (III) will show whether playing games has an effect on loneliness/social network.
Comparison between groups (I) and (II) will show whether the social aspect of games has additional benefits over solo-games on loneliness/social network.
Main study parameters/endpoints: Primary outcome: change in perceived loneliness over time; secondary outcomes: change in (I) social network composition and (II) health-related outcomes over time. All acquired via chatbot questionnaires.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: the participants will have to download and install the app. Participants in the social games group will be invited to play games with people from their own network and may plan as often as they want with whom they want, but are encouraged to play at least twice a week. Participants in the non-personal games group will be invited to play games as often as they want but are encouraged to play at least twice a week. All participants are asked to complete questionnaires. In-app questionnaires will be administered monthly: the complete set of questionnaires at baseline, after 6 months, and after 12 months (duration 1.5 hours), and the loneliness questionnaire monthly (duration 10 minutes) Since the questionnaires contain questions on loneliness and mental wellbeing, some might be perceived as sensitive.
- Conditions
- Loneliness
- Being tested
- SamenSpelen.app, FijnSpelen.app
- Keywords
- Social network, Digital technology, Social games
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SamenSpelen.appOther
An app designed to play simple, social games in a chat environment. These games are designed to elicit personal interaction.
FijnSpelen.appOther
An app designed to play simple, social games in a chat environment. These games are designed to not elicit personal interaction.
| Study group | Role | What they receive |
|---|---|---|
| Social games | Experimental | Participants in the social games group will be given access to an app with games that are either adaptations of well-known games or newly developed games, all designed to be played with just text messages and photos. A game is essentially a chat group with the people you invited to play that specific game with. Participants can play with their own network of family and friends, as well as other people in the same condition. Receives: Other: SamenSpelen.app |
| Non-personal games | Active comparator | Participants in the active control group will be given access to an app that offers 'non-personal games'. The portal will contain a subset of the social games, which have been adapted for non-personal play. This means that all aspects that make the games personal are removed and discouraged. The games that remain can still be played with others (family/friends and others in the same condition), but are designed not to elicit personal interaction. Participants are asked to play the games at least twice a week, but may play as often as they like. Receives: Other: FijnSpelen.app |
| Passive control | No intervention | The passive control group will be given access to an app that contains no games. Similar to the other groups, the portal is used to complete the questionnaires. Use of other games, (gaming) apps or social media platforms is allowed in this group, as in the other groups. The only restriction they will not have access to the games offered in the social games and active control groups. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Loneliness indirect
The change in indirectly measured loneliness (De Jong Gierveld loneliness scale (range 1-11, higher indicating more loneliness)) over three months between the three groups
Measured: Three months
Loneliness direct
The change in directly measured loneliness (Likert scale (range 1-5, higher indicating more loneliness) over three months between the three groups
Measured: Three months
Secondary outcomes (3)
Loneliness time series
The temporal variability in indirectly measured loneliness (De Jong Gierveld loneliness scale (range 1-11, higher indicating more loneliness)) over twelve months
Measured: Twelve months
Wellbeing
The change in wellbeing (SPF-IL) between the groups over twelve months
Measured: Twelve months
Social network composition
The change in social network composition (NESTOR-LSN) between the groups over twelve months
Measured: Twelve months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2021
- Study start1 Apr 2021
- Primary completion28 Mar 2022
- Study completion28 Mar 2022
Why it stopped: Aimed sample size could not be reached within the time that was taken for recruitment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LonelinessStudies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Three different groups will start simultaneously, with each participant in one and only one condition.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Netherlands Organisation for Scientific Research
- Responsible party
- Sponsor
- Investigators
- Marcel Olde Rikkert, MD PhD, Principal investigator, Radboud University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04733898
- Sponsor's protocol ID
- 2020-6884
- Other IDs
- 645.003.002
- Status last verified
- Jan 2021
- First submitted
- 28 Jan 2021
- Last updated
- 31 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymized questionnaire and backend game data will be stored in the repisitory of the Data Archiving and Networked Services (DANS-Easy) after finalizing the project and all data analyses. After that, it is available open access.
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Social Health Games: a Gamified Intervention to Decrease Loneliness in Older Adults - a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04733898
- Acronym / sponsor ID
- 2020-6884
- Conditions
- Loneliness
- Keywords
- Social network, Digital technology, Social games
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Aimed sample size could not be reached within the time that was taken for recruitment.
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Collaborators
- Netherlands Organisation for Scientific Research
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 28 Mar 2022 (actual)
- Study completion
- 28 Mar 2022 (actual)
- First posted
- 2 Feb 2021 (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.
This study examines whether social platform games are effective in expanding the social network and decreasing the experienced levels of loneliness in older adults. The newly developed social games will be compared to non-personal games and not playing games.
Detailed description
Rationale: loneliness and social isolation are an increasing problem in older adults with the aging of society. One option to foster social contact is through online games, which allow social interaction at a distance.
Objective: to investigate whether playing social online games has a beneficial effect on subjective loneliness and social network in older adults, compared with playing non-personal games and not playing games.
Study design: 3-arm randomized controlled trial.
Study population: A sample of 300 human volunteers aged 65 and over, who have access to a smartphone and an internet connection. The sample will be evenly distributed across the three groups.
Everybody else is allowed to use the gaming portal; they will form the pool of people that the participants can play with. This pool will be tracked within the gaming portal and posed some questions regarding their fellow players and their experiences loneliness. People aged under 16 can play but will not be tracked.
Intervention (if applicable): Three groups: (I) Intervention group, who will be given access to an app with the social games, and are encouraged to use this app as much as possible, (II) active control group, who will be given access to an app with non-personal games, and are encouraged to use this app as much as possible, (III) passive control group, who will be given access to an app with no games. The platform has a chatbot designed to take the questionnaires.
Comparison between groups (I+II) and (III) will show whether playing games has an effect on loneliness/social network.
Comparison between groups (I) and (II) will show whether the social aspect of games has additional benefits over solo-games on loneliness/social network.
Main study parameters/endpoints: Primary outcome: change in perceived loneliness over time; secondary outcomes: change in (I) social network composition and (II) health-related outcomes over time. All acquired via chatbot questionnaires.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: the participants will have to download and install the app. Participants in the social games group will be invited to play games with people from their own network and may plan as often as they want with whom they want, but are encouraged to play at least twice a week. Participants in the non-personal games group will be invited to play games as often as they want but are encouraged to play at least twice a week. All participants are asked to complete questionnaires. In-app questionnaires will be administered monthly: the complete set of questionnaires at baseline, after 6 months, and after 12 months (duration 1.5 hours), and the loneliness questionnaire monthly (duration 10 minutes) Since the questionnaires contain questions on loneliness and mental wellbeing, some might be perceived as sensitive.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
- Model description
- Three different groups will start simultaneously, with each participant in one and only one condition.
| Arm | Type | Receives |
|---|---|---|
| Social games | Experimental | Other: SamenSpelen.appParticipants in the social games group will be given access to an app with games that are either adaptations of well-known games or newly developed games, all designed to be played with just text messages and photos. A game is essentially a chat group with the people you invited to play that specific game with. Participants can play with their own network of family and friends, as well as other people in the same condition. |
| Non-personal games | Active comparator | Other: FijnSpelen.appParticipants in the active control group will be given access to an app that offers 'non-personal games'. The portal will contain a subset of the social games, which have been adapted for non-personal play. This means that all aspects that make the games personal are removed and discouraged. The games that remain can still be played with others (family/friends and others in the same condition), but are designed not to elicit personal interaction. Participants are asked to play the games at least twice a week, but may play as often as they like. |
| Passive control | No intervention | –The passive control group will be given access to an app that contains no games. Similar to the other groups, the portal is used to complete the questionnaires. Use of other games, (gaming) apps or social media platforms is allowed in this group, as in the other groups. The only restriction they will not have access to the games offered in the social games and active control groups. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- Being 65 years or older
- Have access to a smartphone with an internet connection
Key exclusion criteria (2 listed)
- Visual or cognitive impairments that limit independent use of a mobile phone
- Not being fluent in the Dutch language
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 |
|---|---|---|
| SamenSpelen.appAn app designed to play simple, social games in a chat environment. These games are designed to elicit personal interaction. | Other | Social games |
| FijnSpelen.appAn app designed to play simple, social games in a chat environment. These games are designed to not elicit personal interaction. | Other | Non-personal games |
Primary outcome
Loneliness indirect
Time frame: Three months
The change in indirectly measured loneliness (De Jong Gierveld loneliness scale (range 1-11, higher indicating more loneliness)) over three months between the three groups
Loneliness direct
Time frame: Three months
The change in directly measured loneliness (Likert scale (range 1-5, higher indicating more loneliness) over three months between the three groups
3 secondary outcomes
Loneliness time series
Time frame: Twelve months
Wellbeing
Time frame: Twelve months
Social network composition
Time frame: Twelve months
Results and safety
The study was stopped early (reason given: Aimed sample size could not be reached within the time that was taken for recruitment.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2023.
- The project website (in Dutch), including information on the studyLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Anonymized questionnaire and backend game data will be stored in the repisitory of the Data Archiving and Networked Services (DANS-Easy) after finalizing the project and all data analyses. After that, it is available open access.
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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.
Marcel Olde Rikkert, MD PhD principal investigator
Radboud University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SamenSpelen.app and FijnSpelen.app in people with Loneliness, run by Radboud University Medical Center at 1 site in Netherlands.
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 2 inclusion and 2 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: stopped early, as of the sponsor's last update on 31 Mar 2023. 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 Netherlands. 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 was stopped early (reason given: Aimed sample size could not be reached within the time that was taken for recruitment.). Results are not available in the source record.
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?
Loneliness indirect (time frame: Three months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 Mar 2023; AzTrials last refreshed its copy on 28 Oct 2026.