NCT03262506

Brief Summary

There is evidence that computerized cognitive training can improve cognition in healthy older adults and in people at risk of developing dementia, although an effective model to implement the training in the daily life of people and to ensure engagement is missing. This project studies the adherence, engagement and progress on computerized cognitive training exercises that were offered by the Association of Retirees from the Telecommunications (ASASTEL) to its associates. One hundred subjects in three different cities (Rio de Janeiro, Belo Horizonte and Brasilia) received licenses to perform the exercises on line and were followed by a team of psychologists. We will evaluate adherence, engagement and progress on the computerized cognitive training exercises of those subjects.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

June 7, 2017

Completed
Same day until next milestone

Study Start

First participant enrolled

June 7, 2017

Completed
3 months until next milestone

First Posted

Study publicly available on registry

August 25, 2017

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2017

Completed
Last Updated

August 25, 2017

Status Verified

August 1, 2017

Enrollment Period

4 months

First QC Date

June 7, 2017

Last Update Submit

August 23, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • Training adherence

    Training adherence will be defined as a continuous variable (number of hours of training completed by the participant).

    1 year

Secondary Outcomes (3)

  • Individual gains on the computerized exercises

    1 year

  • Motivation with the computerized training exercise

    1 year

  • Training adherence (dichotomic variable)

    1 year

Study Arms (1)

Cognitive Training

EXPERIMENTAL
Other: Computerized cognitive training

Interventions

The cognitive training program consists of a set of computerized exercises designed to improve the speed and accuracy of auditory information processing while engaging neuromodulatory systems involved in attention and reward. These exercises continuously adjust the difficulty level to user performance to maintain an approximately 85% rate of correct responses. Trials with correct responses are rewarded with points and animations.

Cognitive Training

Eligibility Criteria

Age60 Years - 99 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • To be an associate of ASASTEL, or the spouse of an associate,
  • To have access to the internet at home and proficiency on accessing and navigating the internet,
  • Availability to be evaluated and followed by the professional team.

You may not qualify if:

  • Any medical condition that precludes performing the computerized training exercises,
  • Score below 27 points in the Mini Mental State Examination (MEEM),
  • Moderated or advanced dementia.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidade Federal do Rio de Janeiro

Rio de Janeiro, Rio de Janeiro, Brazil

RECRUITING

Study Design

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

Study Record Dates

First Submitted

June 7, 2017

First Posted

August 25, 2017

Study Start

June 7, 2017

Primary Completion

September 30, 2017

Study Completion

September 30, 2017

Last Updated

August 25, 2017

Record last verified: 2017-08

Data Sharing

IPD Sharing
Will not share

Locations