Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 74 of 677 for:    amyotrophic lateral sclerosis

A Programme for Amyotrophic Lateral Sclerosis Care in Europe (ALS-CarE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03081338
Recruitment Status : Unknown
Verified August 2017 by Sheffield Teaching Hospitals NHS Foundation Trust.
Recruitment status was:  Active, not recruiting
First Posted : March 16, 2017
Last Update Posted : August 8, 2017
Sponsor:
Information provided by (Responsible Party):
Sheffield Teaching Hospitals NHS Foundation Trust

Brief Summary:
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.

Condition or disease
ALS (Amyotrophic Lateral Sclerosis) MND (Motor Neurone DIsease)

Detailed Description:

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.


Layout table for study information
Study Type : Observational
Estimated Enrollment : 115 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Programme for Amyotrophic Lateral Sclerosis Care in Europe
Study Start Date : May 2015
Estimated Primary Completion Date : March 31, 2018
Estimated Study Completion Date : March 31, 2018


Group/Cohort
Study cohort
A mix of incident and prevalent patient cases will be included in order to capture patients at different stages of the disease trajectory.



Primary Outcome Measures :
  1. Calculation of quality-adjusted life years (QALYs) that are used to inform economic evaluations of health care interventions using the EuroQoL validated EQ-5D-5L questionnaire. [ Time Frame: 4 years ]
    Two potential service changes will be identified through examination of the patient journey and through the review of discordance with existing best practice guidelines. Key areas of interest are likely to be focussed around the organisation and delivery of services for gastrostomy, non-invasive ventilation, management of cognitive and behavioural impairment, and the involvement of specialised palliative care teams. The precise methods used will be determined on consideration of the types of intervention and types of data available, but are likely to include case-matching and/or more sophisticated statistical methods such as logistic regression or propensity scoring.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
A mix of incident and prevalent cases will be included in order to capture patients at different stages of the disease trajectory. The total study population will contain 600 patients (300 newly diagnosed and 300 prevalent).
Criteria

Inclusion Criteria:

  • A diagnosis of definite, probable, laboratory supported or possible ALS according to the El Escorial criteria.

Exclusion Criteria:

  • Patient cognitive impairment to the extent that they cannot complete an informed consent process

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03081338


Locations
Layout table for location information
United Kingdom
Sheffield Institute for Translational Neuroscience
Sheffield, South Yorkshire, United Kingdom, S10 2HQ
Sponsors and Collaborators
Sheffield Teaching Hospitals NHS Foundation Trust

Layout table for additonal information
Responsible Party: Sheffield Teaching Hospitals NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT03081338     History of Changes
Other Study ID Numbers: STH18567
First Posted: March 16, 2017    Key Record Dates
Last Update Posted: August 8, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sheffield Teaching Hospitals NHS Foundation Trust:
ALS, MND, Care, Patient journey
Additional relevant MeSH terms:
Layout table for MeSH terms
Motor Neuron Disease
Amyotrophic Lateral Sclerosis
Sclerosis
Pathologic Processes
Neurodegenerative Diseases
Nervous System Diseases
Neuromuscular Diseases
Spinal Cord Diseases
Central Nervous System Diseases
TDP-43 Proteinopathies
Proteostasis Deficiencies
Metabolic Diseases