NCT04733898

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
76

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2021

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 28, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 2, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

April 1, 2021

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 28, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 28, 2022

Completed
Last Updated

March 31, 2023

Status Verified

January 1, 2021

Enrollment Period

12 months

First QC Date

January 28, 2021

Last Update Submit

March 29, 2023

Conditions

Keywords

Social networkDigital technologySocial games

Outcome Measures

Primary Outcomes (2)

  • 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

    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

    Three months

Secondary Outcomes (3)

  • Loneliness time series

    Twelve months

  • Wellbeing

    Twelve months

  • Social network composition

    Twelve months

Other Outcomes (1)

  • Gaming behaviour and social interactions

    Twelve months

Study Arms (3)

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.

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.

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.

Interventions

An app designed to play simple, social games in a chat environment. These games are designed to elicit personal interaction.

Social games

An app designed to play simple, social games in a chat environment. These games are designed to not elicit personal interaction.

Non-personal games

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • Being 65 years or older
  • Have access to a smartphone with an internet connection

You may not qualify if:

  • Visual or cognitive impairments that limit independent use of a mobile phone
  • Not being fluent in the Dutch language

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Radboudumc

Nijmegen, Gelderland, Netherlands

Location

Related Links

Study Officials

  • Marcel Olde Rikkert, MD PhD

    Radboud University Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Masking Details
The investigator analyzing data will be blind to the group coding and the personal information. Only anonymized data will be available to them.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Three different groups will start simultaneously, with each participant in one and only one condition.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 28, 2021

First Posted

February 2, 2021

Study Start

April 1, 2021

Primary Completion

March 28, 2022

Study Completion

March 28, 2022

Last Updated

March 31, 2023

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP, ANALYTIC CODE
Time Frame
After the end of the project (Mid 2024).
Access Criteria
Open Access

Locations