- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04733898
Social Health Games: The Use of Online Games to Decrease Loneliness in Older Adults
Social Health Games: a Gamified Intervention to Decrease Loneliness in Older Adults - a Randomized Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Gelderland
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Nijmegen, Gelderland, Netherlands
- Radboudumc
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Being 65 years or older
- Have access to a smartphone with an internet connection
Exclusion Criteria:
- Visual or cognitive impairments that limit independent use of a mobile phone
- Not being fluent in the Dutch language
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Social games
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.
|
An app designed to play simple, social games in a chat environment.
These games are designed to elicit personal interaction.
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Active Comparator: Non-personal games
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.
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An app designed to play simple, social games in a chat environment.
These games are designed to not elicit personal interaction.
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No Intervention: Passive control
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
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Three months
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Loneliness direct
Time Frame: Three months
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The change in directly measured loneliness (Likert scale (range 1-5, higher indicating more loneliness) over three months between the three groups
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Three months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Loneliness time series
Time Frame: Twelve months
|
The temporal variability in indirectly measured loneliness (De Jong Gierveld loneliness scale (range 1-11, higher indicating more loneliness)) over twelve months
|
Twelve months
|
Wellbeing
Time Frame: Twelve months
|
The change in wellbeing (SPF-IL) between the groups over twelve months
|
Twelve months
|
Social network composition
Time Frame: Twelve months
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The change in social network composition (NESTOR-LSN) between the groups over twelve months
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Twelve months
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Gaming behaviour and social interactions
Time Frame: Twelve months
|
Data on the games participants play (retrieved from the backend game data), when and with whom they play them (retrieved from questionnaires assessed after games have been played.
Questions on relationship type and intensity have been adapted from the NESTOR-LSN questionnaire.)
|
Twelve months
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Marcel Olde Rikkert, MD PhD, Radboud University Medical Center
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 2020-6884
- 645.003.002 (Other Grant/Funding Number: NWO)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ANALYTIC_CODE
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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