- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT02559700
Online Brain Training Intervention for Over 50s
Optimising Engagement in an Online Brain Training Intervention for Adults Over 50
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
|---|---|
|
Change in reasoning ability as measured by the Baddeley Grammatical Reasoning
Délai: 12 months
|
12 months
|
Mesures de résultats secondaires
Mesure des résultats |
Délai |
|---|---|
|
Change in visual memory and learning as measured by the Paired Associate Learning Test
Délai: 12 months
|
12 months
|
|
Change in reaction time as measured by the Simple and Choice Reaction Test
Délai: 12 months
|
12 months
|
|
Change in spatial working memory as measured by the Spatial Working Memory Test
Délai: 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)
Délai: 12 months
|
12 months
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Anne Corbett, PhD, King's College London
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 188008
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