Clinical Trial Details
— Status: Terminated
Administrative data
| NCT number |
NCT04733898 |
| Other study ID # |
2020-6884 |
| Secondary ID |
645.003.002 |
| Status |
Terminated |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
April 1, 2021 |
| Est. completion date |
March 28, 2022 |
Study information
| Verified date |
January 2021 |
| Source |
Radboud University Medical Center |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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.
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.
