ROADMAP WP2 patients and carers survey
Research type
Research Study
Full title
Real world Outcomes across the AD spectrum for better care: Multi-modal data Access Platform (ROADMAP) - Work package 2 - Outcomes survey
IRAS ID
238491
Contact name
Cathie Sudlow
Contact email
Sponsor organisation
The University of Edinburgh
Clinicaltrials.gov Identifier
16/SS/0156, DART Register Rowling CARE (Edinburgh) ethics number; 12/SS/0196, DART Register E Cog DART (Edinburgh) ethics number
Duration of Study in the UK
0 years, 9 months, 31 days
Research summary
Real world evidence (RWE) - data collected from multiple sources beyond clinical research settings – can potentially help better inform regulators, healthcare providers and scientists in decision making regarding the re-purposing and development of treatments. However, as yet there is no general mapping of the many potential sources of RWE for Alzheimer’s disease or guidance for its interpretation and use.\n\nThis project - ROADMAP - has brought together 22 partners from across Europe as a research consortium to develop a set of key outcome measures and data integration tools related to Alzheimer’s disease, and guidelines on the handling and interpretation of RWE data in this area. The work being undertaken has been divided into eight work packages. This application is for work package 2 (WP2).\nWP2 is a two year project that aims to identify a priority set of real world Alzheimer’s disease focussed outcomes across the disease spectrum from the pre‐clinical to severe stages. WP2 also aims to identify what constitutes a meaningful delay in disease progression from clinical, humanistic and economic perspectives.\n\nThere are four specific activities being undertaken to achieve these aims:\n- Pragmatic literature review to generate initial list of outcomes\n- Systematic literature review to evaluate what is already known about outcome priorities and criteria for meaningful delay in disease progression\n- Stakeholder surveys to determine a priority set of outcomes and criteria for meaningful delay in disease progression.\n- Gap analysis: identify priority outcomes not adequately captured using currently available real world data.\n\nThe stakeholders (participants) in the survey will be 1) people living with mild cognitive impairment, dementia or Alzheimer’s disease; 2) lay carers of people living with these conditions. Recruitment will be via two NHS memory clinics and their associated registers of individuals willing to participate in dementia related research.\n
REC name
North of Scotland Research Ethics Committee 2
REC reference
18/NS/0002
Date of REC Opinion
15 Jan 2018
REC opinion
Favourable Opinion