The purpose of ALS-CarE is to make a population based inventory of the ALS patient and caregiver health care programme over the different stages of the disease. The obtained information can be used in the future to adjust and fine tune the current…
ID
Source
Brief title
Condition
- Neuromuscular disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Effectiveness of the ALS-healthcare programme for patients and caregivers will
be evaluated using QoL, distress and cost effectiveness measures.
McGill quality of life questionnaire, the Schedule for the Evaluation of
Individual Quality of Life (SeiQoL) and 5Q-5D-5L, and anxiety and depression
(Hospital Anxiety and Depression scale).
Additionally, for a subset of patients and caregivers an exploratory nested
study (N=25) will be conducted which includes detailed quality of life
assessments including existential domains, attitudes to end of life, advance
directives and decision-making and meaning of life developed by the Munich
ALS-CarE partners will be applied.
Secondary outcome
Correlates of QoL, anxiety, depression and caregiver burden with ALS severity
which will be measured with ALS-FRS-R, Mitos and Kings staging, Edinburgh
Cognitive ALS screen (ECAS), Vital Capacity and Sniff Nasal Inspiratory
Pressure (SNIP) (part 3 of the data collection for patients).
Background summary
Amyotrophic Lateral Sclerosis (ALS) 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.
Study objective
The purpose of ALS-CarE is to make a population based inventory of the ALS
patient and caregiver health care programme over the different stages of the
disease. The obtained information can be used in the future to adjust and fine
tune the current care programmes. To get insight into the management of the
disease, information about Quality of life, costs, personal attitudes and
experiences of both patient and caregiver will be assessed across different
stages of the disease. The completed project will provide a user-friendly best
practice framework for the care and management of ALS patients and their care
givers. Possibly, these insights can also be used for management of other
closely related neurodegenerative diseases.
Study design
Longitudinal exploratory observational study in six European countries with
four measurement points at a four months interval. A mix of incident and
prevalent ALS cases will be included in order to capture patients at different
stages of the disease trajectory.
Study burden and risks
The burden for the ALS patients and their caregivers consists of answering
questions from the questionnaire as assessed by the two research nurses during
the home visit In addition, the patient is asked to carry out some behavioral
tests and a vital capacity measurement to assess the severity of the ALS. The
patient and caregiver will be assessed during 90 minutes at the same time. Four
home visits will be scheduled over a period of 12 months and a close out visit
at 18 months.
The risks of this study are negligible. We try to minimize the time investment
and effort of the patient and caregiver by home visits and assessment at the
same time by a research nurse and assistant. Participation in the study will
not result in a direct benefit for patient and/or carers. The added value of
this research lies in its international approach in which the (effectiveness of
these) care programs for ALS patients and caregivers in six different countries
is evaluated. In this way, best practices can be identified and exchanged which
will be of benefit for future patients and caregivers.
Heidelberglaan 100
Utrecht 3584 CX
NL
Heidelberglaan 100
Utrecht 3584 CX
NL
Listed location countries
Age
Inclusion criteria
In order to be eligible to participate in this study, a patient (age > 18 years) must meet all of the following criteria: Possible, Probable, Laboratory Supported Probably and Definite ALS according to the El Escorial Criteria.Caregivers have to be older than 18 years.
Exclusion criteria
Patients who are impaired to the extent that they cannot complete an informed consent process are excluded from participation in the study.
Patients who already participate in study 16-273 (NL56989.041.16)
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL56609.041.16 |