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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
King's College London
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Dementia focused on measuring Healthy Ageing

Eligibility Criteria

50 Years - 110 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

    First Posted
    September 23, 2015
    Last Updated
    November 5, 2019
    Sponsor
    King's College London
    Collaborators
    Alzheimer's Society, Imperial College London
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    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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