Amyotropic Lateral Sclerosis (ALS) muscle disease
Conditions
Interventions
None listed
Sponsors
divisie hersenen
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
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
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 outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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). | — |
Countries
Netherlands
Outcome results
None listed