Viewing Study NCT04733898



Ignite Creation Date: 2024-05-06 @ 3:43 PM
Last Modification Date: 2024-10-26 @ 1:55 PM
Study NCT ID: NCT04733898
Status: TERMINATED
Last Update Posted: 2023-03-31
First Post: 2021-01-28

Brief Title: Social Health Games The Use of Online Games to Decrease Loneliness in Older Adults
Sponsor: Radboud University Medical Center
Organization: Radboud University Medical Center

Study Overview

Official Title: Social Health Games a Gamified Intervention to Decrease Loneliness in Older Adults - a Randomized Controlled Trial
Status: TERMINATED
Status Verified Date: 2021-01
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Aimed sample size could not be reached within the time that was taken for recruitment
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief 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
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 III and III will show whether playing games has an effect on lonelinesssocial network

Comparison between groups I and II will show whether the social aspect of games has additional benefits over solo-games on lonelinesssocial network

Main study parametersendpoints 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 15 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 Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None
Secondary IDs
Secondary ID Type Domain Link
645003002 OTHER_GRANT NWO None