Clinical trial NCT06418646: Patients' and Caregivers' Views of Multidimensional Care in Amyotropic Lateral Sclerosis in Germany
Official title: Patients' and Caregivers' Views of Multidimensional Care in Amyotropic Lateral Sclerosis in Germany
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Amyotrophic Lateral Sclerosis
Keywords: palliative care
caregiver burden
multidimensional care
Lead sponsor: Technische Universität Dresden
Sponsor class: OTHER
Collaborators: name: ALS Association
name: German Society of Muscle Diseases
First posted: 2024-05-17
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with Amyotrophic Lateral Sclerosis and their caregivers

Brief summary: The progressive loss of physical functioning resulting from ALS leads also to high psychosocial burden for those affected, and organizational challenges related to medical care and aids. A multidimensional and -professional care is advised in order to meet the complex requirements of this disease. In Germany, medical care structures may not fulfil these high requirements, since non-medical services such as psychological support or social counselling are not regularly included in care procedures for ALS patients. Specialised palliative care is not a standard and still commonly restricted to the last weeks of life. Additionally, it is well known that caregivers of ALS patients are highly burdened, but there is a lack of support services for them.

By means of a cross-sectional, multicentre survey, we aim to investigate patients' and caregivers' perception of medical care for ALS, provided in Germany - with particular regard to psychosocial and palliative aspects. The extent to which physical, psychological, social, spiritual, practical and informational needs are subjectively met will be assessed and correlations with mental wellbeing, subjective quality of life, attitudes towards life-sustaining measures and physician-assisted suicide, as well as caregiver burden will be examined.

Currently, study planning (questionnaires and ethical approval) is already completed and recruitment was started. The study aims to recruit 500 participants from nationwide ALS-centres. Cooperating ALS-centres will be recruited via the German Network for Motoneuron Diseases (MND-Net), of which our centre is a member. It is intended to provide data-based starting points on how care of ALS patients and their caregivers can be improved in Germany, in line with their needs.


Eligibility criteria: Inclusion Criteria:

* patients with at least "possible ALS" according to El-Escorial-criteria
* at least 18 years old
* no impairments of behaviour or mental performance relevant to everyday life that limits the ability to make judgments or give consent (e.g. as part of a comorbid FTD)

Exclusion Criteria:

* impairments of behaviour or mental performance relevant to everyday life that limits the ability to make judgments or give consent (e.g. as part of a comorbid FTD)

Primary outcomes:
measure: patients' satisfaction with professional care
timeFrame: baseline
Secondary outcomes:
measure: subjective quality of life
timeFrame: baseline
measure: mental wellbeing
timeFrame: baseline
measure: caregiver burden
timeFrame: baseline
measure: attitudes towards life-sustaining measures and assisted suicide
timeFrame: baseline
Other outcomes:
Locations:
city: Dresden
country: Germany
facility: University Hospital Carl Gustav Carus at Technische Universität Dresden
state: Saxony
Study officials:
affiliation: University Hospital Carl Gustav Carus at Technische Universität Dresden
name: René Günther, PD Dr.
role: PRINCIPAL_INVESTIGATOR
References: