Amyotrophic Lateral SclerosisNCT06418646
Patients' and Caregivers' Views of Multidimensional Care in Amyotropic Lateral Sclerosis in Germany
An observational study of Amyotrophic Lateral Sclerosis, run by Technische Universität Dresden at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Amyotrophic Lateral Sclerosis
- How many people
- 500 participants
- Where
- 1 siteGermany
- Study dates
- 1 Aug 2022to 30 Jun 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with Amyotrophic Lateral Sclerosis and their caregivers
Who may be able to join
- 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)
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
University Hospital Carl Gustav Carus at Technische Universität Dresden
Dresden, Saxony, 01307
Katharina Linse, Dr., 004935145819792, katharina.linse@ukdd.de
René Günther, PD Dr., 03514582532, rene.guenther@ukdd.de
About this study
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
- Medical subject headings
- Amyotrophic Lateral Sclerosis, Caregiver Burden
What is being measured
The primary outcome is the main question the study is designed to answer.
patients' satisfaction with professional care
patients' satisfaction with professional care for potential symptoms in the six domains physical, psychological, social, spiritual, practical and informational
Measured: baseline
Secondary outcomes (4)
subjective quality of life
McGill QoL
Measured: baseline
mental wellbeing
HADS
Measured: baseline
caregiver burden
CBI
Measured: baseline
attitudes towards life-sustaining measures and assisted suicide
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2024
- Study start1 Aug 2022
- Primary completion31 Dec 2024 (estimated)
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Amyotrophic Lateral SclerosisStudies of the same condition, open and under way.
- More trials run by Technische Universität DresdenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Technische Universität Dresden
- Sponsor type
- University, hospital or other
- Collaborators
- ALS Association, German Society of Muscle Diseases
- Responsible party
- Sponsor
- Investigators
- René Günther, PD Dr., Principal investigator, University Hospital Carl Gustav Carus at Technische Universität Dresden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06418646
- Sponsor's protocol ID
- ALSpsychosoz
- Status last verified
- May 2024
- First submitted
- 8 May 2024
- Last updated
- 17 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Upon reasonable request including a methodologically sound proposal for the usage of data approved by the responsible review committee, data may be shared.
Publications
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.
PubMed 38961496
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patients' and Caregivers' Views of Multidimensional Care in Amyotropic Lateral Sclerosis in Germany
- ClinicalTrials.gov ID
- NCT06418646
- Acronym / sponsor ID
- ALSpsychosoz
- Conditions
- Amyotrophic Lateral Sclerosis
- Keywords
- palliative care, caregiver burden, multidimensional care
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Technische Universität DresdenUniversity, hospital or other
- Collaborators
- ALS Association, German Society of Muscle Diseases
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 17 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with Amyotrophic Lateral Sclerosis and their caregivers
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (1 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
patients' satisfaction with professional care
Time frame: baseline
patients' satisfaction with professional care for potential symptoms in the six domains physical, psychological, social, spiritual, practical and informational
4 secondary outcomes
subjective quality of life
Time frame: baseline
mental wellbeing
Time frame: baseline
caregiver burden
Time frame: baseline
attitudes towards life-sustaining measures and assisted suicide
Time frame: baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2024.
- Derived from this study: PubMed 38961496Linse 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.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. Upon reasonable request including a methodologically sound proposal for the usage of data approved by the responsible review committee, data may be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
René Günther, PD Dr. principal investigator
University Hospital Carl Gustav Carus at Technische Universität Dresden
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Amyotrophic Lateral Sclerosis, run by Technische Universität Dresden at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Katharina Linse, Dr. (004935145819792, katharina.linse@ukdd.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
patients' satisfaction with professional care (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06418646, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2024.