Online Brain Training Intervention for Over 50s

NCT ID: NCT02559700

Last Updated: 2019-11-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 4387 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-11-30
• Study Completion Date: 2019-03-31

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.

Conditions

Dementia; Mild Cognitive Impairment

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Brain training programme

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.

Group Type: EXPERIMENTAL

Brain training programme

Intervention Type: BEHAVIORAL

An online package of brain training programmes

Interventions

Brain training programme

An online package of brain training programmes

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 110 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Alzheimer's Society

OTHER

Sponsor Role: collaborator

Imperial College London

OTHER

Sponsor Role: collaborator

King's College London

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Anne Corbett, PhD

Role: PRINCIPAL_INVESTIGATOR

King's College London

Other Identifiers

188008

Identifier Type: -

Identifier Source: org_study_id