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天发娱乐棋牌_天发娱乐APP-官网|下载 Clinical Trials Unit

recon

Trial Name

RECON -?Reducing and preventing Cognitive impairment iN older age groups.

Description

Dementia in the over 65s occurs in 6.5% of the population, and the number will increase with a progressively ageing population. Reduced functioning (‘cognitive impairment’) is more common - including Mild Cognitive Impairment (MCI) and Age Associated Cognitive decline (AACD) - and approximately 5% progress to dementia annually. Intensive promotion of lifestyle (diet/physical activity) and cognitive exercises slow cognitive decline but use considerable staff resource.

RECON will investigate the use of a website called ‘Active Brains’ which aims to help older adults to look after their brain and body health by preventing problems with memory, concentration and reasoning which may assist in slowing cognitive decline.

Objectives

The RECON study aims to evaluate:

  • The effectiveness and cost-effectiveness in maintaining cognitive functioning of a complex internet supported behavioural intervention to promote healthy behaviours (diet and physical activity) and perform cognitive exercises.
  • The effectiveness and cost-effectiveness in maintaining cognitive functioning of a complex internet supported behavioural intervention to promote healthy behaviours and perform cognitive exercises when supported as necessary by a trained behavioural facilitator.

Design

A feasibility trial will be conducted initially to examine the study and intervention procedures, and ensure they are feasible for the future planned Randomised Controlled Trial (RCT).

The future planned, fully powered, definitive trial will test the effectiveness and cost-effectiveness of both Active Brains and Active Brains plus support from a central facilitator, to see if either of these interventions can maintain cognitive function and prevent cognitive decline.

The findings of the feasibility study may be used to make modifications to the study or intervention procedures to ensure the success of the later planned definitive trial.

In both the feasibility and fully powered trials, patients will be randomly allocated to one of three study groups:

  1. Usual care
  2. Access to the Active Brains website
  3. Access to the Active Brains website with flexible human support from a central support facilitator

Population

The total sample size across both groups will be a minimum of 360 participants for the feasibility trial from two patient populations:

  • 60 patients for each of the three study groups from participants who currently show signs of MCI or AACD (180 total).
  • 60 patients to each of the three study groups from a group of participants without cognitive decline (180 total).

Contacts

Sponsor: University of 天发娱乐棋牌_天发娱乐APP-官网|下载

Chief Investigators: Prof Paul Little & Prof Lucy Yardley

RECON Website

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