## Protocol Section
### Identification Module
**NCT ID:** NCT06418646

**Brief Title:** 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

#### Organization Study ID Info
**ID:** ALSpsychosoz
#### Organization
**Class:** OTHER
**Full Name:** Technische Universität Dresden
### Status Module
#### Completion Date
**Date:** 2025-06-30

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-17

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-13

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2024-12-31

**Type:** ESTIMATED

#### Start Date
**Date:** 2022-08-01

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-17
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-08
**Study First Submit QC Date:** 2024-05-13
### Sponsor Collaborators Module

#### Collaborators

**Class:** OTHER

**Name:** ALS Association

**Class:** UNKNOWN

**Name:** German Society of Muscle Diseases

#### Lead Sponsor

**Class:** OTHER

**Name:** Technische Universität Dresden

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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 Module

**Conditions:**

- Amyotrophic Lateral Sclerosis

**Keywords:**

- palliative care

- caregiver burden

- multidimensional care

### Design Module

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 500

**Type:** ESTIMATED

**Study Type:** OBSERVATIONAL

### Outcomes Module

#### Primary Outcomes

**Description:** patients' satisfaction with professional care for potential symptoms in the six domains physical, psychological, social, spiritual, practical and informational

**Measure:** patients' satisfaction with professional care

**Time Frame:** baseline

#### Secondary Outcomes

**Description:** McGill QoL

**Measure:** subjective quality of life

**Time Frame:** baseline

**Description:** HADS

**Measure:** mental wellbeing

**Time Frame:** baseline

**Description:** CBI

**Measure:** caregiver burden

**Time Frame:** baseline

**Measure:** attitudes towards life-sustaining measures and assisted suicide

**Time Frame:** baseline

### Eligibility Module

**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)

**Minimum Age:** 18 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

**Study Population:** patients with Amyotrophic Lateral Sclerosis and their caregivers

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** katharina.linse@ukdd.de

**Name:** Katharina Linse, Dr.

**Phone:** 004935145819792

**Role:** CONTACT

**Contact 2:**

**Email:** rene.guenther@ukdd.de

**Name:** René Günther, PD Dr.

**Phone:** 00493514582532

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Dresden

**Contacts:**

***Contact 1:***

- **Email:** katharina.linse@ukdd.de

- **Name:** Katharina Linse, Dr.

- **Phone:** 004935145819792

- **Role:** CONTACT

***Contact 2:***

- **Email:** rene.guenther@ukdd.de

- **Name:** René Günther, PD Dr.

- **Phone:** 03514582532

- **Role:** CONTACT

**Country:** Germany

**Facility:** University Hospital Carl Gustav Carus at Technische Universität Dresden

**State:** Saxony

**Status:** RECRUITING

**Zip:** 01307

#### Overall Officials

**Official 1:**

**Affiliation:** University Hospital Carl Gustav Carus at Technische Universität Dresden

**Name:** René Günther, PD Dr.

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**Description:** Upon reasonable request including a methodologically sound proposal for the usage of data approved by the responsible review committee, data may be shared.

**IPD Sharing:** UNDECIDED

### References Module

#### See Also Links

**Label:** Related Info

**URL:** http://mnd-net.de

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000010335

- Term: Pathologic Processes

- ID: D000019636

- Term: Neurodegenerative Diseases

- ID: D000009422

- Term: Nervous System Diseases

- ID: D000009468

- Term: Neuromuscular Diseases

- ID: D000013118

- Term: Spinal Cord Diseases

- ID: D000002493

- Term: Central Nervous System Diseases

- ID: D000057177

- Term: TDP-43 Proteinopathies

- ID: D000057165

- Term: Proteostasis Deficiencies

- ID: D000008659

- Term: Metabolic Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BXM

- Name: Behaviors and Mental Disorders

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: BC10

- Name: Nervous System Diseases

- Abbrev: BC18

- Name: Nutritional and Metabolic Diseases

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M2480

- Name: Caregiver Burden

- Relevance: LOW

- As Found: Unknown

- ID: M15415

- Name: Sclerosis

- Relevance: HIGH

- As Found: Sclerosis

- ID: M18879

- Name: Motor Neuron Disease

- Relevance: HIGH

- As Found: Lateral Sclerosis

- ID: M4024

- Name: Amyotrophic Lateral Sclerosis

- Relevance: HIGH

- As Found: Amyotrophic Lateral Sclerosis

- ID: M21558

- Name: Neurodegenerative Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M12411

- Name: Neuromuscular Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M15915

- Name: Spinal Cord Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M5742

- Name: Central Nervous System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M28759

- Name: TDP-43 Proteinopathies

- Relevance: LOW

- As Found: Unknown

- ID: M28747

- Name: Proteostasis Deficiencies

- Relevance: LOW

- As Found: Unknown

- ID: M11639

- Name: Metabolic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: T349

- Name: Amyotrophic Lateral Sclerosis

- Relevance: HIGH

- As Found: Amyotrophic Lateral Sclerosis

- ID: T4699

- Name: Primary Lateral Sclerosis

- Relevance: HIGH

- As Found: Lateral Sclerosis

### Condition Browse Module - Meshes

- ID: D000016472

- Term: Motor Neuron Disease

- ID: D000000690

- Term: Amyotrophic Lateral Sclerosis

- ID: D000012598

- Term: Sclerosis

### Misc Info Module

- Version Holder: 2024-05-31
