NCT02798081

Brief Summary

A minimum of 23 people aged 60 years and older, of both sexes, from an informatics course for beginners will participate in the study. The evaluation will consist mainly in answering two validated questionnaires on socialization, the short Social and Emotional Loneliness Scale for Adults (SELSA-S) and short-form UCLA Loneliness Scale (ULS-6). Reaction time and performance will also be measured by three virtual reality games, namely Reaction Time, Random and Moviletrando. All this evaluation will be repeated in three moments: T0 - at baseline; T1 - after 8 conventional informatics classes and; T2 - after 8 informatics classes which includes 15 minutes for practicing virtual reality games.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2016

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 31, 2016

Completed
14 days until next milestone

First Posted

Study publicly available on registry

June 14, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

August 1, 2016

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2017

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

February 8, 2018

Status Verified

February 1, 2018

Enrollment Period

11 months

First QC Date

May 31, 2016

Last Update Submit

February 6, 2018

Conditions

Aged

Keywords

augmentative and alternative communicationsocial inclusionserious gamesInformation and communication technologies

Outcome Measures

Primary Outcomes (1)

  • Socialization assessed by SELSA-S

    Improvement on self-perceived loneliness, representing the socialization level of the elderly, comparing baseline to the first 8 usual computer classes and after the 8 classes with virtual reality games. This will be verified through a decrease in the score of SELSA-S. SELSA-S has 15 items, scoring up to 7 in each, 105 in total.

    up to 10 weeks

Secondary Outcomes (1)

  • time of response during the practise of virtual reality games as assessed by TRT, Random and Moviletrando

    up to 10 weeks

Study Arms (1)

Single arm study

EXPERIMENTAL

A minimum of 46 elderly, students of a informatics course, will participate in the study. Initially, the students will have 8 usual informatics classes in the institution where they were enrolled spontaneously. Then, during the next 8 classes (from class 9 to class 16) they will practice 10 minutes of virtual reality games, as part of the class.

Behavioral: Single arm study

Interventions

Single arm studyBEHAVIORAL

In Step 1 the elderly will participate of eight conventional computer classes which they were spontaneously enrolled. In Step 2, 10 minutes of the next eight classes will be used to practice serious games using virtual reality, using physical interface (keyboard or mouse).

Also known as: practicing virtual reality games
Single arm study

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • people aged over 60 years;
  • both sexes
  • spontaneously enrolled in the informatics beginner class for seniors of the Center of Reference for Elderly (CRI) in Ribeirão Pires

You may not qualify if:

  • Less than 75% of frequency in the classes between the assessments;
  • do not completion of the three moments of assessment;
  • having motor impairment of the upper limbs or cognition impairment,which prevents them to practice the games.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculdade de Medicina do ABC

Santo André, São Paulo, 09060-650, Brazil

Location

Related Publications (1)

  • Antunes TPC, Oliveira ASB, Crocetta TB, Antao JYFL, Barbosa RTA, Guarnieri R, Massetti T, Monteiro CBM, Abreu LC. Computer classes and games in virtual reality environment to reduce loneliness among students of an elderly reference center: Study protocol for a randomised cross-over design. Medicine (Baltimore). 2017 Mar;96(10):e5954. doi: 10.1097/MD.0000000000005954.

    PMID: 28272198DERIVED

MeSH Terms

Conditions

Social Inclusion

Condition Hierarchy (Ancestors)

Social BehaviorBehavior

Study Officials

  • Thaiany Antunes, Master

    Faculdade de Medicina do ABC

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Master

Study Record Dates

First Submitted

May 31, 2016

First Posted

June 14, 2016

Study Start

August 1, 2016

Primary Completion

July 1, 2017

Study Completion

December 1, 2017

Last Updated

February 8, 2018

Record last verified: 2018-02

Data Sharing

IPD Sharing
Will not share

Locations

BR(1)