Online Brain Training Intervention for Over 50s
Primary Purpose
Dementia, Mild Cognitive Impairment
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Brain training programme
Sponsored by
About this trial
This is an interventional prevention trial for Dementia focused on measuring Healthy Ageing
Eligibility Criteria
Inclusion Criteria:
- Over 50,
- Have access to a computer and the internet
- Registered as a participant on the PROTECT website
Exclusion Criteria:
- Established diagnosis of dementia
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Brain training programme
Arm Description
Participants will complete a package of online brain training games focusing on reasoning and problem solving. The intervention will be accessed via a computer. There is no minimum or maximum dosage but participants will be recommended to complete the intervention five times a week. The package takes approximately 10 minutes to complete, depending on individual performance.
Outcomes
Primary Outcome Measures
Change in reasoning ability as measured by the Baddeley Grammatical Reasoning
Secondary Outcome Measures
Change in visual memory and learning as measured by the Paired Associate Learning Test
Change in reaction time as measured by the Simple and Choice Reaction Test
Change in spatial working memory as measured by the Spatial Working Memory Test
Change in ability to complete day-to-day activities as measured by the Instrumental Activities of Daily Living scale (part of the Home Care Minimum Dataset)
Full Information
NCT ID
NCT02559700
First Posted
September 23, 2015
Last Updated
November 5, 2019
Sponsor
King's College London
Collaborators
Alzheimer's Society, Imperial College London
1. Study Identification
Unique Protocol Identification Number
NCT02559700
Brief Title
Online Brain Training Intervention for Over 50s
Official Title
Optimising Engagement in an Online Brain Training Intervention for Adults Over 50
Study Type
Interventional
2. Study Status
Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
November 2015 (Actual)
Primary Completion Date
March 31, 2018 (Actual)
Study Completion Date
March 31, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
King's College London
Collaborators
Alzheimer's Society, Imperial College London
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study is an open trial investigating the long-term use of an online brain training programme for adults over 50. It will determine whether there is sustained benefit to cognition, and whether this group can be engaged in this form of intervention over a period of 12 months.
Detailed Description
This study will evaluate an optimised brain training programme to determine whether it is engaging for older adults and whether it results in improvement or maintenance of cognition over a 12 month period.
The Brain Training intervention
The programme is an updated version of the original 'Brain Test Britain' intervention, which was successfully evaluated in a large previous trial. It consists of a series of games or tests, completed on a computer. Each test is designed to target the participants' reasoning and problem-solving ability, for example by asking them to balance weights on a see-saw or select the 'odd-one-out' from a series of shapes. As the participants progress over the course of the study they will receive increasingly more challenging versions of each test, depending on their performance. The intervention has been updated from the original to improve engagement through improved visuals, more intelligent difficulty setting and a more engaging delivery platform.
The research delivery platform: PROTECT
A novel infrastructure resource has been developed at King's College London within the Maudsley Biomedical Research Unit for Dementia (BRU-D), which provides the opportunity to deliver the intervention to large numbers of older adults. The Platform for Research Online to investigate Cognition and Genetics in Ageing (PROTECT) is an online research tool. PROTECT is currently recruiting a cohort of over 10,000 adults over 50 who are cognitively healthy or have early cognitive impairment. Participants provide demographic and lifestyle information and will complete a battery of validated cognitive assessments annually. The focus of all research conducted through PROTECT is on the prevention of dementia and risk reduction. The optimised brain training intervention will be delivered through this platform. PROTECT has ethical approval from the NHS Research Ethics Service Committee for London Bridge (Ref: 13/LO/1578).
Study Design
Design: 12-month open online clinical trial Participants: 5000 adults over 50 Setting: Intervention delivered at home, online through the PROTECT website
Recruitment
Recruitment will be achieved through the PROTECT site through a national advertisement strategy. This will be accomplished through partnerships with the media and third sector. All participants registered on PROTECT will be invited to take part and provided with the information sheet. Participants will consent through the secure online procedure on the PROTECT site.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dementia, Mild Cognitive Impairment
Keywords
Healthy Ageing
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
4387 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Brain training programme
Arm Type
Experimental
Arm Description
Participants will complete a package of online brain training games focusing on reasoning and problem solving. The intervention will be accessed via a computer. There is no minimum or maximum dosage but participants will be recommended to complete the intervention five times a week. The package takes approximately 10 minutes to complete, depending on individual performance.
Intervention Type
Behavioral
Intervention Name(s)
Brain training programme
Intervention Description
An online package of brain training programmes
Primary Outcome Measure Information:
Title
Change in reasoning ability as measured by the Baddeley Grammatical Reasoning
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Change in visual memory and learning as measured by the Paired Associate Learning Test
Time Frame
12 months
Title
Change in reaction time as measured by the Simple and Choice Reaction Test
Time Frame
12 months
Title
Change in spatial working memory as measured by the Spatial Working Memory Test
Time Frame
12 months
Title
Change in ability to complete day-to-day activities as measured by the Instrumental Activities of Daily Living scale (part of the Home Care Minimum Dataset)
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
110 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Over 50,
Have access to a computer and the internet
Registered as a participant on the PROTECT website
Exclusion Criteria:
Established diagnosis of dementia
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anne Corbett, PhD
Organizational Affiliation
King's College London
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Online Brain Training Intervention for Over 50s
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