Online Grammatical Reasoning Training for Older Adults (START)

April 16, 2019 updated by: University of Exeter

Impact of Short-term Intensive Online Grammatical Reasoning Training on Cognition and Function in Adults Over 50: An Online Randomised Controlled Trial

The START study will investigate the impact of playing a Grammatical Reasoning brain training task on overall brain function (cognition) and day-to-day function in people over 50.

The study builds on existing work that has shown very promising results with brain training approaches in older adults. There is good evidence that playing brain training games leads to improvements in brain functions including memory and reasoning. There is also a suggestion that regular involvement in brain training games might help reduce the risk of cognitive decline and dementia later in life. It appears that reasoning, or problem-solving, is particularly important as it is one of the first abilities to decline with age. This study will use this evidence to target reasoning in a specific brain training task. It will also explore the potential role of genetic factors in how people perform in the task.

The study will compare the impact of a Grammatical Reasoning Task (START) with a control task consisting of simple picture-matching. Over 7000 participants will be randomly allocated to either START or the control and will be asked to play the task as often as they wish for a period of six weeks. Both tasks will be delivered entirely online so people will access the study from home on their computers. This will be achieved through our dedicated online research platform, PROTECT, which hosts a cohort of over 20,000 older adults who have provided DNA samples as part of a longitudinal study.

This study will measure the impact of the training on cognition and Instrumental Activities of Daily Living. Assessments will be completed online at baseline, two/six weeks and six months. Overall, this study aims to generate exciting new data about how brain training could be included in guidance on healthy ageing.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

7240

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Exeter, United Kingdom, EX1 2LU
        • University of Exeter Medical School

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Adults over 50
  • Access to a computer with a keyboard and the internet
  • Participant registered on the PROTECT study

Exclusion Criteria:

  • Diagnosis of dementia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Grammatical Reasoning
This group will complete a short-term Intensive Grammatical Reasoning cognitive task delivered online by Wesnes Cognition Ltd (START). Participants will be encouraged to complete the START training once a day for six-weeks.
Other: Grammatical Reasoning
START measures the ability to determine the relationships among different shape combinations which are assigned to grammatical statements about them which can be either correct or incorrect. It is a measure of attention, working memory and executive control.
Other Names:
  • START
Other: Control - Card Pairs
The control group will complete a basic picture-matching task that will provide the same level of engagement, but without the learning effects.
Other: Card Pairs
A basic picture-matching task.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
A composite measure of cognitive function
Time Frame: Participants will be directed to complete these measures at baseline, two/ six weeks and six months
The primary outcome measure will be a composite measure of cognitive function, created through a combined score of each of the measures described below. The individual measures will be included as discrete secondary outcome measures. All outcome measures will be completed online. They are sensitive to change in cognition, and validated for use in older adults to detect early changes in cognition.
Participants will be directed to complete these measures at baseline, two/ six weeks and six months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Executive function
Time Frame: Baseline, two weeks, six weeks and 6 months
Measured by a test of visual attention, the Trail making B, which is a validated measure for use in this population.
Baseline, two weeks, six weeks and 6 months
Executive function
Time Frame: Baseline, two weeks, six weeks and 6 months
Measured by a test of task-switching, the Switching Stroop Test, which is a validated measure for use in this population.
Baseline, two weeks, six weeks and 6 months
Cognitive function
Time Frame: Baseline, two weeks, six weeks and 6 months
Measured through the Baddeley Logical Reasoning Task (letter sequence)11 - part of the Wesnes Cognition Ltd CogTrackTM system.
Baseline, two weeks, six weeks and 6 months
Cognitive function
Time Frame: Baseline, two weeks, six weeks and 6 months
Measured through a Digit Vigilance test as part of the Wesnes Cognition Ltd CogTrackTM system.
Baseline, two weeks, six weeks and 6 months
Cognitive function
Time Frame: Baseline, two weeks, six weeks and 6 months
Measured through a Simple and Choice Reaction time test as part of the Wesnes Cognition Ltd CogTrackTM system.
Baseline, two weeks, six weeks and 6 months
Cognitive function
Time Frame: Baseline, two weeks, six weeks and 6 months
Measured through a Spatial Working Memory test as part of the Wesnes Cognition Ltd CogTrackTM system.
Baseline, two weeks, six weeks and 6 months
Cognitive function
Time Frame: Baseline, two weeks, six weeks and 6 months
Measured through a Numeric Working Memory test as part of the Wesnes Cognition Ltd CogTrackTM system.
Baseline, two weeks, six weeks and 6 months
Cognitive function
Time Frame: Baseline, two weeks, six weeks and 6 months
Measured through a Pattern Separation test as part of the Wesnes Cognition Ltd CogTrackTM system.
Baseline, two weeks, six weeks and 6 months
Cognitive function
Time Frame: Baseline, two weeks, six weeks and 6 months
Measured through a Word Recall (delayed and immediate) test as part of the Wesnes Cognition Ltd CogTrackTM system.
Baseline, two weeks, six weeks and 6 months
Cognitive function
Time Frame: Baseline, two weeks, six weeks and 6 months
Measured through a Word Recognition test as part of the Wesnes Cognition Ltd CogTrackTM system.
Baseline, two weeks, six weeks and 6 months
Verbal Learning
Time Frame: Baseline, two weeks, six weeks and 6 months
Measured through the validated Paired Associate Learning measure, which is highly sensitive to change in cognition and has been used to predict conversion to Alzheimer's Disease in people with cognitive impairment.
Baseline, two weeks, six weeks and 6 months
Instrumental Activities of Daily Living (IADL)
Time Frame: Baseline, two weeks, six weeks and 6 months
Measured by the modified Instrumental Activities of Daily Living measure which is validated for use in this population, and has been successfully used to show change in IADL in previous online brain training studies.
Baseline, two weeks, six weeks and 6 months
Use of cognitive training
Time Frame: 6 months
Participants will complete a brief question regarding their use of cognitive training (computer games, crosswords, Sudoku etc) and the regularity of use
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Exeter

Collaborators

King's College London
South London and Maudsley NHS Foundation Trust
Wesnes Cognition Ltd

Investigators

  • Principal Investigator: Anne Corbett, BSc MRes PhD, University of Exeter Medical School

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 31, 2017

Primary Completion (Actual)

May 31, 2018

Study Completion (Actual)

November 30, 2018

Study Registration Dates

First Submitted

July 30, 2018

First Submitted That Met QC Criteria

September 3, 2018

First Posted (Actual)

September 7, 2018

Study Record Updates

Last Update Posted (Actual)

April 17, 2019

Last Update Submitted That Met QC Criteria

April 16, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • 216941

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified individual participant data (IPD) that underlie results in a publication or for secondary data analysis purposes.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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