Patients' and Caregivers' Views of Multidimensional Care in Amyotropic Lateral Sclerosis in Germany

Amyotrophic Lateral Sclerosis Clinical Trial

Official title:

Patients' and Caregivers' Views of Multidimensional Care in Amyotropic Lateral Sclerosis in Germany

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06418646
• Other study ID #: ALSpsychosoz
• Status: Recruiting
• Start date: August 1, 2022
• Est. completion date: June 30, 2025

Study information

• Verified date: May 2024
• Source: Technische Universität Dresden
• Contact: Katharina Linse, Dr.
• Phone: 004935145819792
• Email: katharina.linse[@]ukdd.de
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: June 30, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Amyotrophic Lateral Sclerosis
• Motor Neuron Disease
• Sclerosis

Locations

Country	Name	City	State
Germany	University Hospital Carl Gustav Carus at Technische Universität Dresden	Dresden	Saxony

Sponsors (3)

Lead Sponsor	Collaborator
Technische Universität Dresden	ALS Association, German Society of Muscle Diseases

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	patients' satisfaction with professional care	patients' satisfaction with professional care for potential symptoms in the six domains physical, psychological, social, spiritual, practical and informational	baseline
Secondary	subjective quality of life	McGill QoL	baseline
Secondary	mental wellbeing	HADS	baseline
Secondary	caregiver burden	CBI	baseline
Secondary	attitudes towards life-sustaining measures and assisted suicide		baseline

External Links

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