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

Recruiting

• Conditions: Amyotrophic Lateral Sclerosis

• Registration Number: NCT06418646
• Lead Sponsor: Technische Universität Dresden

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-08-01
• Status Verified: 2024-05
• Study First Submitted: 2024-05-08
• Study First Submitted QC: 2024-05-13
• Last Update Submitted: 2024-05-13
• Study First Posted: 2024-05-17
• Last Update Posted: 2024-05-17
• Primary Completion: 2024-12-31
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 500

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
patients' satisfaction with professional care	baseline	patients' satisfaction with professional care for potential symptoms in the six domains physical, psychological, social, spiritual, practical and informational

Secondary Outcome Measures

Name	Time	Method
caregiver burden	baseline	CBI
attitudes towards life-sustaining measures and assisted suicide	baseline
subjective quality of life	baseline	McGill QoL
mental wellbeing	baseline	HADS

Trial Locations

Locations (1)

University Hospital Carl Gustav Carus at Technische Universität Dresden; 🇩🇪 Dresden, Saxony, Germany