- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT02559700
Online Brain Training Intervention for Over 50s
Optimising Engagement in an Online Brain Training Intervention for Adults Over 50
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Prevenzione
- Assegnazione: N / A
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: 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
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
|---|---|
|
Change in reasoning ability as measured by the Baddeley Grammatical Reasoning
Lasso di tempo: 12 months
|
12 months
|
Misure di risultato secondarie
Misura del risultato |
Lasso di tempo |
|---|---|
|
Change in visual memory and learning as measured by the Paired Associate Learning Test
Lasso di tempo: 12 months
|
12 months
|
|
Change in reaction time as measured by the Simple and Choice Reaction Test
Lasso di tempo: 12 months
|
12 months
|
|
Change in spatial working memory as measured by the Spatial Working Memory Test
Lasso di tempo: 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)
Lasso di tempo: 12 months
|
12 months
|
Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Anne Corbett, PhD, King's College London
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 188008
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
Prove cliniche su Brain training programme
-
Stanford UniversityCompletatoSindrome da deficit di attenzione e iperattivitàStati Uniti
-
Indiana UniversityCompletatoScompenso cardiaco Classe NYHA II | Insufficienza cardiaca Classe NYHA III | Scompenso cardiaco Classe NYHA IStati Uniti
-
University of Electronic Science and Technology...CompletatoAttività dell'insula anteriore durante la regolazione | Risposte empatiche dopo la regolazione dell'insula anteriore
-
University of AarhusCompletato
-
Hopeful AgingReclutamento
-
Mental Health Services in the Capital Region, DenmarkCopenhagen Trial Unit, Center for Clinical Intervention Research; Center for...CompletatoPazienti ad altissimo rischio di psicosiDanimarca
-
Rousselot BVBAKGK Science Inc.Non ancora reclutamento
-
University of ManitobaCancerCare ManitobaAttivo, non reclutanteCancro | Deterioramento cognitivo | Disfunzione cognitiva | Adolescenti | Giovani adultiCanada
-
Akron Children's HospitalCompletato
-
University of British ColumbiaCompletatoStimolazione cerebrale profonda | Disfonia spasmodica | Distonia laringeaCanada