- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT02559700
Online Brain Training Intervention for Over 50s
Optimising Engagement in an Online Brain Training Intervention for Adults Over 50
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Förebyggande
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Experimentell: 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.
|
An online package of brain training programmes
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
---|---|
Change in reasoning ability as measured by the Baddeley Grammatical Reasoning
Tidsram: 12 months
|
12 months
|
Sekundära resultatmått
Resultatmått |
Tidsram |
---|---|
Change in visual memory and learning as measured by the Paired Associate Learning Test
Tidsram: 12 months
|
12 months
|
Change in reaction time as measured by the Simple and Choice Reaction Test
Tidsram: 12 months
|
12 months
|
Change in spatial working memory as measured by the Spatial Working Memory Test
Tidsram: 12 months
|
12 months
|
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)
Tidsram: 12 months
|
12 months
|
Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Anne Corbett, PhD, King's College London
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 188008
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