Cognitive Training to Promote Brain Health: Implementation and Engagement
Primary Purpose
Aging, Mild Cognitive Impairment
Status
Unknown status
Phase
Phase 2
Locations
Ireland
Study Type
Interventional
Intervention
Computerized cognitive training
Sponsored by
About this trial
This is an interventional prevention trial for Aging
Eligibility 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.
Sites / Locations
- St James HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Cognitive training
Arm Description
Outcomes
Primary Outcome Measures
Engagement
will be defined as a continuous variable (number of hours of training completed by the participant).
Secondary Outcome Measures
Individual gains on the computerized exercises
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.
Quantitative measure of motivation with the computerized training exercise
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.
Qualitative motivation with the computerized training exercise
Qualitative motivation will be assessed using semi-structured interview.
Training adherence (dichotomic variable)
Training adherence will be defined as training more than 10 hours
Full Information
NCT ID
NCT03408509
First Posted
January 12, 2018
Last Updated
January 24, 2018
Sponsor
Universidade Federal do Rio de Janeiro
Collaborators
University of Dublin, Trinity College, Global Brain health Institute
1. Study Identification
Unique Protocol Identification Number
NCT03408509
Brief Title
Cognitive Training to Promote Brain Health: Implementation and Engagement
Official Title
Cognitive Training to Promote Brain Health: Implementation and Engagement
Study Type
Interventional
2. Study Status
Record Verification Date
January 2018
Overall Recruitment Status
Unknown status
Study Start Date
January 12, 2018 (Actual)
Primary Completion Date
December 31, 2019 (Anticipated)
Study Completion Date
December 31, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade Federal do Rio de Janeiro
Collaborators
University of Dublin, Trinity College, Global Brain health Institute
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aging, Mild Cognitive Impairment
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Cognitive training
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Computerized cognitive training
Intervention Description
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.
Primary Outcome Measure Information:
Title
Engagement
Description
will be defined as a continuous variable (number of hours of training completed by the participant).
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Individual gains on the computerized exercises
Description
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.
Time Frame
3 months
Title
Quantitative measure of motivation with the computerized training exercise
Description
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.
Time Frame
3 months
Title
Qualitative motivation with the computerized training exercise
Description
Qualitative motivation will be assessed using semi-structured interview.
Time Frame
3 months
Title
Training adherence (dichotomic variable)
Description
Training adherence will be defined as training more than 10 hours
Time Frame
3 months
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rogerio A Panizzutti, M.D., Ph.D.
Phone
+552139386390
Email
rogerio@icb.ufrj.br
First Name & Middle Initial & Last Name or Official Title & Degree
Andrea Fantinatti, B.Sc.
Phone
+552139386390
Email
afantinatti@yahoo.com.br
Facility Information:
Facility Name
St James Hospital
City
Dublin
ZIP/Postal Code
D8
Country
Ireland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Brian Lawlor, M.D.
Email
BLAWLOR@STJAMES.IE
12. IPD Sharing Statement
Learn more about this trial
Cognitive Training to Promote Brain Health: Implementation and Engagement
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