A program for ALS Care in Europe

Completed

Conditions: Amyotropic Lateral Sclerosis (ALS) muscle disease
10029317

Registration Number: NL-OMON46176

Lead Sponsor: divisie hersenen

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 120

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)

Study & Design

Study Type: Observational non invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Effectiveness of the ALS-healthcare programme for patients and caregivers will<br /><br>be evaluated using QoL, distress and cost effectiveness measures.<br /><br>McGill quality of life questionnaire, the Schedule for the Evaluation of<br /><br>Individual Quality of Life (SeiQoL) and 5Q-5D-5L, and anxiety and depression<br /><br>(Hospital Anxiety and Depression scale).<br /><br><br /><br>Additionally, for a subset of patients and caregivers an exploratory nested<br /><br>study (N=25) will be conducted which includes detailed quality of life<br /><br>assessments including existential domains, attitudes to end of life, advance<br /><br>directives and decision-making and meaning of life developed by the Munich<br /><br>ALS-CarE partners will be applied. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Correlates of QoL, anxiety, depression and caregiver burden with ALS severity<br /><br>which will be measured with ALS-FRS-R, Mitos and Kings staging, Edinburgh<br /><br>Cognitive ALS screen (ECAS), Vital Capacity and Sniff Nasal Inspiratory<br /><br>Pressure (SNIP) (part 3 of the data collection for patients).</p><br>