- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03262506
Evaluation of Adherence and Engagement in a Cognitive Training Program for Older Adults
August 23, 2017 updated by: Rogerio Panizzutti, Universidade Federal do Rio de Janeiro
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.
Study Overview
Study Type
Interventional
Enrollment (Anticipated)
100
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
RJ
-
Rio de Janeiro, RJ, Brazil
- Recruiting
- Universidade Federal do Rio de Janeiro
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
60 years to 99 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Cognitive Training
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Training adherence
Time Frame: 1 year
|
Training adherence will be defined as a continuous variable (number of hours of training completed by the participant).
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Individual gains on the computerized exercises
Time Frame: 1 year
|
The computerized cognitive training platform, called BrainHQ, provided by Posit Science Inc, provides the individual gains on the computerized exercises with training.
|
1 year
|
Motivation with the computerized training exercise
Time Frame: 1 year
|
Motivation will be assessed by quantitative (measured as a percentage of all stimulus sets available in the exercises of the BrainHq computerized cognitive training platform) and qualitative questionnaires (Adapted Ultrech Engagement Scale - UWES).
|
1 year
|
Training adherence (dichotomic variable)
Time Frame: 1 year
|
Additionally training adherence will be defined as a dichotomic variable (below or above 10 hours of training).
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 7, 2017
Primary Completion (Anticipated)
September 30, 2017
Study Completion (Anticipated)
September 30, 2017
Study Registration Dates
First Submitted
June 7, 2017
First Submitted That Met QC Criteria
August 23, 2017
First Posted (Actual)
August 25, 2017
Study Record Updates
Last Update Posted (Actual)
August 25, 2017
Last Update Submitted That Met QC Criteria
August 23, 2017
Last Verified
August 1, 2017
More Information
Terms related to this study
Other Study ID Numbers
- ASASTEL study
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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