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

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.

Study Overview

• Status: Recruiting
• Conditions: Amyotrophic Lateral Sclerosis

• Study Type: Observational
• Enrollment (Estimated): 500

Contacts and Locations

• Study Contact: Name: Katharina Linse, Dr.; Phone Number: 004935145819792; Email: katharina.linse@ukdd.de
• Study Contact Backup: Name: René Günther, PD Dr.; Phone Number: 00493514582532; Email: rene.guenther@ukdd.de

Study Locations

• Germany
  • Saxony
    • Dresden, Saxony, Germany, 01307
      • Recruiting
      • University Hospital Carl Gustav Carus at Technische Universität Dresden
      • Contact: Katharina Linse, Dr.; Phone Number: 004935145819792; Email: katharina.linse@ukdd.de
      • Contact: René Günther, PD Dr.; Phone Number: 03514582532; Email: rene.guenther@ukdd.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

patients with Amyotrophic Lateral Sclerosis and their caregivers

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
subjective quality of life	McGill QoL	baseline
mental wellbeing	HADS	baseline
caregiver burden	CBI	baseline
attitudes towards life-sustaining measures and assisted suicide		baseline

Collaborators and Investigators

• Sponsor: Technische Universität Dresden
• Collaborators: ALS Association; German Society of Muscle Diseases
• Investigators: Principal Investigator: René Günther, PD Dr., University Hospital Carl Gustav Carus at Technische Universität Dresden

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2022
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): June 30, 2025

Study Registration Dates

• First Submitted: May 8, 2024
• First Submitted That Met QC Criteria: May 13, 2024
• First Posted (Actual): May 17, 2024

Study Record Updates

• Last Update Posted (Actual): May 17, 2024
• Last Update Submitted That Met QC Criteria: May 13, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: palliative care; caregiver burden; multidimensional care
• Additional Relevant MeSH Terms: Pathologic Processes; Metabolic Diseases; Central Nervous System Diseases; Nervous System Diseases; Neuromuscular Diseases; Neurodegenerative Diseases; Spinal Cord Diseases; TDP-43 Proteinopathies; Proteostasis Deficiencies; Sclerosis; Motor Neuron Disease; Amyotrophic Lateral Sclerosis
• Other Study ID Numbers: ALSpsychosoz

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Upon reasonable request including a methodologically sound proposal for the usage of data approved by the responsible review committee, data may be shared.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No