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

NCT06418646 | Recruiting

• 1 other identifier: ALSpsychosoz
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

Amyotrophic Lateral Sclerosis

Keywords

palliative care; caregiver burden; multidimensional care

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• subjective quality of life

  baseline

• mental wellbeing

  baseline

• caregiver burden

  baseline

• attitudes towards life-sustaining measures and assisted suicide

  baseline

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients with Amyotrophic Lateral Sclerosis and their caregivers

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Technische Universität Dresden: lead
• ALS Association: collaborator
• German Society of Muscle Diseases: collaborator

Study Sites (1)

University Hospital Carl Gustav Carus at Technische Universität Dresden

Dresden, Saxony, 01307, Germany

RECRUITING

Related Publications (1)

• Linse K, Weber C, Reilich P, Schoberl F, Boentert M, Petri S, Rodiger A, Posa A, Otto M, Wolf J, Zeller D, Brunkhorst R, Koch J, Hermann A, Grosskreutz J, Schroter C, Gross M, Lingor P, Machetanz G, Semmler L, Dorst J, Lule D, Ludolph A, Meyer T, Maier A, Metelmann M, Regensburger M, Winkler J, Schrank B, Kohl Z, Hagenacker T, Brakemeier S, Weyen U, Weiler M, Lorenzl S, Bublitz S, Weydt P, Grehl T, Kotterba S, Lapp HS, Freigang M, Vidovic M, Aust E, Gunther R. Patients' and caregivers' perception of multidimensional and palliative care in amyotrophic lateral sclerosis - protocol of a German multicentre study. Neurol Res Pract. 2024 Jul 4;6(1):34. doi: 10.1186/s42466-024-00328-1.

  PMID: 38961496 DERIVED

Related Links

• Related Info

MeSH Terms

Conditions

Amyotrophic Lateral Sclerosis; Caregiver Burden

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Motor Neuron Disease; Neurodegenerative Diseases; TDP-43 Proteinopathies; Neuromuscular Diseases; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases; Stress, Psychological; Behavioral Symptoms; Behavior

Study Officials

• René Günther, PD Dr.

  University Hospital Carl Gustav Carus at Technische Universität Dresden

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Katharina Linse, Dr.

CONTACT

004935145819792; katharina.linse@ukdd.de

René Günther, PD Dr.

CONTACT

00493514582532; rene.guenther@ukdd.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 8, 2024
• First Posted: May 17, 2024
• Study Start: August 1, 2022
• Primary Completion: December 31, 2024
• Study Completion: June 30, 2025
• Last Updated: May 17, 2024

Record last verified: 2024-05

Locations

DE (1)