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Cognitive Training to Promote Brain Health: Implementation and Engagement

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ClinicalTrials.gov Identifier: NCT03408509
Recruitment Status : Unknown
Verified January 2018 by Rogerio Panizzutti, Universidade Federal do Rio de Janeiro.
Recruitment status was:  Recruiting
First Posted : January 24, 2018
Last Update Posted : January 26, 2018
Sponsor:
Collaborators:
University of Dublin, Trinity College
Global Brain health Institute
Information provided by (Responsible Party):
Rogerio Panizzutti, Universidade Federal do Rio de Janeiro

Study Description
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Brief Summary:
Cognition encompasses memory, attention, language and other brain capacities that are necessary for good quality of life and independence. Age-related cognitive decline starts at the third decade of life and in some cases can start to impact daily functioning in the late forties. Dementia is the most devastating consequence associated with age-related cognitive decline. Recent studies indicate that improving cognition by means of intensive computerized brain training can mitigate some aspects of agerelated cognitive decline, and may even have a role in preventing or delaying dementia onset. Critically, the capacity of a given individual to improve their cognitive performance after training is fundamentally related to engagement with the exercises. Currently, little is known about how to apply intensive computerized cognitive training effectively in the health system, ensuring engagement and best progress. This project aims to tackle this challenge by developing, applying and testing personalized approaches to implement cognitive training in daily life of older adults that were recently evaluated at Memory Clinics and their care partners. The community readiness approach will be implemented using semi-structured interviews, conducted with subjects that may be interested in cognitive training, key informant, and key stakeholders. Using this information, the investigators will design an individualized training program and follow up its application in a feasibility trial. Twenty participants, recently evaluated at different Memory Clinics in Ireland, will be recruited, interviewed and invited to engage, over the ensuing 2 to 3 months, in computerized cognitive training. Subjects will be assessed after completion of the intervention for training adherence and individual gains on the computerized exercises. In order to gain insight about regional specificities of the approach the investigators will perform a parallel project using the same methodology in Brazil. This project is expected to inform the future implementation of cognitive training in public health policies for older adults.

Condition or disease Intervention/treatment Phase
Aging Mild Cognitive Impairment Behavioral: Computerized cognitive training Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Cognitive Training to Promote Brain Health: Implementation and Engagement
Actual Study Start Date : January 12, 2018
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2019
Arms and Interventions
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Arm Intervention/treatment
Experimental: Cognitive training Behavioral: Computerized cognitive training
Posit Science Inc. will supply the software for the computerized cognitive training through the platform BrainHQ, which is available on line. The training program consists of a set of computerized exercises designed to improve the speed and accuracy of sensory information processing while engaging neuromodulatory systems involved in attention and reward. The rationale is that, in order to understand and remember information, the brain must first generate precise and reliable neurological responses that represent the sensory stimuli. 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. The goal is to increase the effectiveness with which these stimuli engage and drive plastic changes in brain systems. Engagement is monitored by electronic data upload following each training session.


Outcome Measures
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Primary Outcome Measures :
  1. Engagement [ Time Frame: 3 months ]
    will be defined as a continuous variable (number of hours of training completed by the participant).


Secondary Outcome Measures :
  1. Individual gains on the computerized exercises [ Time Frame: 3 months ]
    The computerized cognitive training platform, called BrainHQ, provided by Posit Science Inc, provides one measure of the individual gains on the computerized exercises with training.

  2. Quantitative measure of motivation with the computerized training exercise [ Time Frame: 3 months ]
    Motivation will be assessed by the quantitative score provided by the Adapted Ultrech Engagement Scale - UWES. The Utrecht Engagement Scale has 17 items that are scored on a 7-point Likert scale indicating the frequency with which engagement at a given activity happens in the situations described in each item (0 indicates "never" and 6 "always"). The factors Vigor and Concentration have six items each and the factor Dedication has 5 items. The final score of the Engagement corresponds to the sum of the scores on the three factors.

  3. Qualitative motivation with the computerized training exercise [ Time Frame: 3 months ]
    Qualitative motivation will be assessed using semi-structured interview.

  4. Training adherence (dichotomic variable) [ Time Frame: 3 months ]
    Training adherence will be defined as training more than 10 hours


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Being evaluated at a memory clinic in the last year, or be the care partner of a person evaluated at a memory clinic
  • Adequate visual and auditory acuity to allow practice on the computerized training exercises
  • Physical ability sufficient to allow performance of the computerized training exercises
  • Provide signed and dated informed consent form.
  • Willing to comply with all study procedures and be available for the duration of the study.

Exclusion Criteria:

  • Any medical condition that precludes performing the computerized training exercises
  • Advanced dementia.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03408509


Contacts
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Contact: Rogerio A Panizzutti, M.D., Ph.D. +552139386390 rogerio@icb.ufrj.br
Contact: Andrea Fantinatti, B.Sc. +552139386390 afantinatti@yahoo.com.br

Locations
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Ireland
St James Hospital Recruiting
Dublin, Ireland, D8
Contact: Brian Lawlor, M.D.       BLAWLOR@STJAMES.IE   
Sponsors and Collaborators
Universidade Federal do Rio de Janeiro
University of Dublin, Trinity College
Global Brain health Institute
More Information
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Responsible Party: Rogerio Panizzutti, Associate Professor, Universidade Federal do Rio de Janeiro
ClinicalTrials.gov Identifier: NCT03408509    
Other Study ID Numbers: GBHI_ALZ-18-544160
First Posted: January 24, 2018    Key Record Dates
Last Update Posted: January 26, 2018
Last Verified: January 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Cognitive Dysfunction
Cognition Disorders
Neurocognitive Disorders
Mental Disorders