ALS (Amyotrophic Lateral Sclerosis) Clinical Trial
Official title:
A Programme for Amyotrophic Lateral Sclerosis Care in Europe
Amyotrophic Lateral Sclerosis (ALS) or else known as Motor Neurone Disease (MND) is a rapidly progressive fatal neurological disease that strikes in the prime of life, and for which there is no treatment. The principal aim of management is to maintain quality of life and reduce the symptoms of the disease. This requires a multidisciplinary approach using best practice for symptom alleviation, including innovation approaches towards maximising quality of life. The purpose of this study is to use existing information drawn from partner countries into a system of care that is available to people with amyotrophic lateral sclerosis at the correct time, in the correct format and in a cost effective manner. This will be achieved by collecting details of patient and carer experiences across all stages of from diagnosis to end of life, including decision making in the terminal stages of the disease. A health economic analysis will help to identify the overall costs of disease management, provide models of increased efficiency that preserve and maximize quality of life, and begin to develop novel health economic measurement tools for terminal neurological illness. The completed project will provide a user-friendly best practice programme for amyotrophic lateral sclerosis that can be modified for management of other related degenerative diseases of the nervous system.
This is a prospective multi-centre observational research project that will be carried out by
8 European partners in 9 sites: 1 in Ireland (Dublin), 1 in the Netherlands (Utrecht), 2 in
the United Kingdom (UK) (Sheffield and London), 2 in Italy (Turin and Milan), 2 in Germany
(Berlin and Munich), and 1 in Belgium (Leuven). In terms of data collection, the study
consists of 3 substudies and will be organised in 6 interlinked work packages spanning
clinical, epidemiological and health services research.
All partners will contribute in participant recruitment and collect comparable data, which
will be used for fulfilling the deliverables of each work package. Central co-ordination of
research activities in the 2 UK sites will be undertaken in Sheffield. This protocol concerns
research activities in relation to the ALS-CarE project involving the 2 UK-based
participating sites.
Following ethical and research governance approvals, ALS-CarE officially started on 1st April
2014 and will run for 3 years. Participant recruitment will commence following ethical and
research governance approval and will occur for the first 4 months at the Sheffield and
King's College MND Care Centres. The follow-up period of each participant will take 12 months
depending on the rate of progression of the illness. Finally, a period of 11 months at the
end of the project will enable analysis of data, dissemination of findings and report
writing.
SCIENTIFIC SUMMARY
Background:
Amyotrophic Lateral Sclerosis (ALS) or else known as Motor Neurone Disease (MND) is a
progressive neurodegenerative disease that strikes in the prime of life. There are currently
no effective disease modifying therapies for ALS and death usually occurs within 3 years of
symptom onset. Management is palliative and is aimed at maximising quality of life and
minimising the burden of disease. The complexity and rapidly progressive nature of ALS
requires a responsive multidisciplinary care system that that is built on reliable disease
staging and evidence based symptom management.
Aim:
To incorporate detailed clinical information drawn from population based sources into a
responsive care programme.
Plan of investigation:
A standardised staging system will be validated, and quality of life and patient experiences
will be measured and management optimised across disease stages from diagnosis to end of
life. Health economic analysis will identify key differences in resource utilisation and will
be useful for pharmaco-economic analyses of new therapeutics.
Potential impact:
The completed project will provide a user-friendly best practice framework for ALS that can
be modified for management of other neurodegenerative diseases.
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