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Online Brain Training Intervention for Over 50s

5. november 2019 oppdatert av: King's College London

Optimising Engagement in an Online Brain Training Intervention for Adults Over 50

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.

Studieoversikt

Status

Fullført

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Faktiske)

4387

Fase

  • Ikke aktuelt

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

50 år til 110 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Ja

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Forebygging
  • Tildeling: N/A
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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

Hva måler studien?

Primære resultatmål

Resultatmål
Tidsramme
Change in reasoning ability as measured by the Baddeley Grammatical Reasoning
Tidsramme: 12 months
12 months

Sekundære resultatmål

Resultatmål
Tidsramme
Change in visual memory and learning as measured by the Paired Associate Learning Test
Tidsramme: 12 months
12 months
Change in reaction time as measured by the Simple and Choice Reaction Test
Tidsramme: 12 months
12 months
Change in spatial working memory as measured by the Spatial Working Memory Test
Tidsramme: 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)
Tidsramme: 12 months
12 months

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Etterforskere

  • Hovedetterforsker: Anne Corbett, PhD, King's College London

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

1. november 2015

Primær fullføring (Faktiske)

31. mars 2018

Studiet fullført (Faktiske)

31. mars 2019

Datoer for studieregistrering

Først innsendt

23. september 2015

Først innsendt som oppfylte QC-kriteriene

23. september 2015

Først lagt ut (Anslag)

24. september 2015

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

7. november 2019

Siste oppdatering sendt inn som oppfylte QC-kriteriene

5. november 2019

Sist bekreftet

1. oktober 2019

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Andre studie-ID-numre

  • 188008

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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