Amyotrophic Lateral SclerosispotentiALSNCT06441448
potentiALS - Quality of Life Among Patients With Amyotrophic Lateral Sclerosis
An observational study of Amyotrophic Lateral Sclerosis, run by University of Leipzig at 1 site in Germany.
Trial summary
Amyotrophic lateral sclerosis (ALS) is a rapidly progressing and disabling disease with the majority of patients dying 3-5 years after symptom onset. Given the high symptom burden, many patients and its caregivers are highly distressed. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Amyotrophic Lateral Sclerosis
- What is being tested?
- case focus groups
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 54 participants
- Where
- 1 siteGermany
- Study dates
- 1 Jan 2024to 31 Dec 2024
- 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: The study population includes 20 dyads of individuals affected by ALS and their caregivers, 4 expert patients, and 10 healthcare professionals. The recruitment is conducted through patient networks and personal contacts established by the patient representative and the project leader (e.g., within neuropalliative networks). The project leader will also invite medical personnel through his networks and in the course of his clinical work (e.g., within the "Clinic for Motor Neuron Diseases" at Leipzig University Hospital) to participate in the study. Affected individuals may also be invited to participate in the study by the project leader during their medical treatment.
Who may be able to join
- patients met criteria for definite/laboratory-supported probable/clinically probable/possible familial or sporadic ALS (diagnostically synonymous with MND) or MND variants (progressive muscular atrophy or primary lateral sclerosis according to the revised El Escorial criteria
- ≥ 18 years old
- fluent in German
- ability to communicate thoughts and feelings
- ability to provide written consent
- anticipated remaining lifespan of ≥ 9 months.
Who cannot join
- under 18 years old
- had a clinical need for gastrostomy feeding or non-invasive ventilation
- had a diagnosis of dementia
- inability to consent
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
University Medical Center Leipzig
Leipzig, Saxony, 04103
Moritz Metelmann, PhD, +49 341 - 97 24209, moritz.metelmann@medizin.uni-leipzig.de
Anja Mehnert, PhD
About this study
Official title: potentiALS - A Multi-method Participatory Aproach to Identify Potentials in Improving Quality of Life Among Patients With Amyotrophic Lateral Sclerosis
Amyotrophic lateral sclerosis (ALS) is a rapidly progressing and disabling disease with the majority of patients dying 3-5 years after symptom onset. Given the high symptom burden, many patients and its caregivers are highly distressed. However, few programs to improve mental health for this patient group exist, and the sparse research implies that programs effective in other medical conditions may not be feasible in ALS patients. Therefore, it is highly needed to involve ALS patients, caregivers and medical staff as contributors into the development of such programs to meet the needs they really have.
The envisaged project has two aims: First, the investigators want to examine whether and how it is possible to involve ALS patients in the whole research process despite rapid disease progress and severe functional impairments. Second, the investigators are interested in how contributors (i.e., patients, caregivers and medical staff) would compile a concrete psychotherapeutic program, i.e., how they set priorities in terms of format, content and treatment techniques of such a program.
Read more
The investigators will closely collaborate with contributors across the whole project in designing the research process, planning assessment as well as interpreting and disseminating the findings. At the end of the study, the investigators will gather contributor feedback on their experience with the participatory approach.
Results will provide important information on how ALS patients can be effectively involved in psychosocial intervention research. Identified priorites regarding psychotherapeutic programs will serve as concrete starting points to develop and test a disease-specific program within a subsequent study.
Read the detailed description
Amyotrophic lateral sclerosis (ALS) is a neurogenerative multi-systemic disease with various symptoms including weakness, cramps, pain, inappropriate affect or speech problems. ALS is inevitably fatal, with the majority of patients dying within 3-5 years after symptom onset as a result of ventilatory failure.
Given the symptom burden and the fatal nature of the disease, many patients are highly distressed. ALS patients show elevated rates of depressive symptoms and impaired quality of life, and levels of anxiety increase with progressing disease. About one third of patients suffer from moderate or severe hopelessness which in turn is associated with desire for hastened death.
The mental burden warrants effective psychological treatments to improve quality of life (QoL) among this patient group. However, few psychosocial interventions studies exist whose results do not allow for strong recommendations due to issues regarding methodology and acceptability. Recently, our own working group failed to apply a psychotherapy effective in palliative cancer patients to ALS patients (publication in preparation, see https://clinicaltrials.gov/ct2/show/NCT03975608).
Therefore, concepts feasible in other populations may not meet the specific needs of ALS patients. Indeed, various disease-specific facilitators have been identified such as flexible format, diseasespecific content tailoring, fostering of patient autonomy, but also barriers such as high effort in reaching and undergoing the intervention and functional decline. Based on such findings, psychotherapeutic programs for ALS patients should be co-designed within a participatory approach to overcome problems with feasibility and acceptability. However, the investigators identified only one study applying a similar approach; however, it was placed in a complete different health care context.
The investigators herein envisage a conceptual phase closely collaborating with various contributors, i.e., patients, caregivers and medical staff. The first objective is to assess the ability and benefit in collaborating with ALS patients in psychosocial intervention research. As second objective, contributors will prioritize their needs in psychological interventions regarding format, content and techniques. Results will be used in an exploratory trial to co-design a psychotherapeutic program ensuring good feasibility and acceptability.
The research questions of the first objective are the following:
- How high is the response rate of contributors to be involved in this participatory project?
- Which participative methods are applicable among ALS patients or need to be adapted?
- How do contributors evaluate the possbility to collaborate in psychosocial intervention research?
- What are the lessons learned and how can they be transferred to participatory psychosocial intervention research among severe (neurodegenerative) diseases? The main research questions related to the second objective are the following:
- How do contributors prioritize treatment-related factors in format, content and techniques?
- Which factor-specific barriers for feasibility and acceptability are anticipated by contributors?
- What are the main findings to serve as starting point for co-designing a disease-specific treatment program within an exploratory future trial?
- Conditions
- Amyotrophic Lateral Sclerosis
- Being tested
- case focus groups
- Keywords
- participatory aproach, quality of life, psychotherapeutic program
- Medical subject headings
- Amyotrophic Lateral Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
case focus groupsBehavioural
The study is in a monocentric, exploratory, participatory study conceptualization phase. Within the study, a mixed-methods assessment involves various interview and group exercise formats among scientists, medical personnel, affected individuals, and their caregivers to develop components for a future psychotherapeutic program for ALS patients and their caregivers. Therapists provide an overview of therapy forms by presenting components based on format, content, and applied techniques. Case studies and focus groups are used for practical experience for the participants. Participants qualitatively assess the significance of therapeutic approaches and make a quantitative prioritization to establish a ranking of therapy components.
What is being measured
The primary outcome is the main question the study is designed to answer.
Response rate
The investigators will assess the amount of eligible patients which are willing to participate in the study relative to the amount of patients who were invited to participate.
Measured: through study completion, an average of 1 year
Secondary outcomes (1)
Level of Quality of Life
Assessed by a questionnaire, the Amyotrophic Lateral Sclerosis Assessment Questionnaires - short form (ALSAQ-5). The total score across the 5 items, rated on a 4-point Likert scale, will be presented (range: 0 - 20). Higher values indicate higher quality of life.enable ranking of preferences as well as qualitative focus groups/interviews for in-depth analyses.
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2024
- Study start1 Jan 2024
- Primary completion31 Aug 2024 (estimated)
- Study completion31 Dec 2024 (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.
- 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
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Leipzig
- Sponsor type
- University, hospital or other
- Collaborators
- Leipzig University Medical Center
- Responsible party
- Principal investigator, Anja Mehnert, University of Leipzig
- Investigators
- Moritz Metelmann, PhD, Principal investigator, Universitätsklinikum Leipzig
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06441448
- Sponsor's protocol ID
- 01KG2321
- Acronym
- potentiALS
- Status last verified
- May 2024
- First submitted
- 5 Jan 2024
- Last updated
- 4 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Heyne S, Kuzmanova A, Esser P, Linse K, Gunther R, Mehnert-Theuerkauf A, Metelmann M. How can we reduce psychological burden for patients of amyotrophic lateral sclerosis and their family caregivers? - Insights from the participatory multi-method study "potentiALS". BMC Neurol. 2025 Oct 7;25(1):414. doi: 10.1186/s12883-025-04440-w.
PubMed 41057832
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- potentiALS - A Multi-method Participatory Aproach to Identify Potentials in Improving Quality of Life Among Patients With Amyotrophic Lateral Sclerosis
- ClinicalTrials.gov ID
- NCT06441448
- Acronym / sponsor ID
- potentiALS / 01KG2321
- Conditions
- Amyotrophic Lateral Sclerosis
- Keywords
- participatory aproach, quality of life, psychotherapeutic program
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- University of LeipzigUniversity, hospital or other
- Collaborators
- Leipzig University Medical Center
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 31 Aug 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 4 Jun 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.
Amyotrophic lateral sclerosis (ALS) is a rapidly progressing and disabling disease with the majority of patients dying 3-5 years after symptom onset. Given the high symptom burden, many patients and its caregivers are highly distressed. However, few programs to improve mental health for this patient group exist, and the sparse research implies that programs effective in other medical conditions may not be feasible in ALS patients. Therefore, it is highly needed to involve ALS patients, caregivers and medical staff as contributors into the development of such programs to meet the needs they really have.
The envisaged project has two aims: First, the investigators want to examine whether and how it is possible to involve ALS patients in the whole research process despite rapid disease progress and severe functional impairments. Second, the investigators are interested in how contributors (i.e., patients, caregivers and medical staff) would compile a concrete psychotherapeutic program, i.e., how they set priorities in terms of format, content and treatment techniques of such a program.
The investigators will closely collaborate with contributors across the whole project in designing the research process, planning assessment as well as interpreting and disseminating the findings. At the end of the study, the investigators will gather contributor feedback on their experience with the participatory approach.
Results will provide important information on how ALS patients can be effectively involved in psychosocial intervention research. Identified priorites regarding psychotherapeutic programs will serve as concrete starting points to develop and test a disease-specific program within a subsequent study.
Detailed description
Amyotrophic lateral sclerosis (ALS) is a neurogenerative multi-systemic disease with various symptoms including weakness, cramps, pain, inappropriate affect or speech problems. ALS is inevitably fatal, with the majority of patients dying within 3-5 years after symptom onset as a result of ventilatory failure.
Given the symptom burden and the fatal nature of the disease, many patients are highly distressed. ALS patients show elevated rates of depressive symptoms and impaired quality of life, and levels of anxiety increase with progressing disease. About one third of patients suffer from moderate or severe hopelessness which in turn is associated with desire for hastened death.
The mental burden warrants effective psychological treatments to improve quality of life (QoL) among this patient group. However, few psychosocial interventions studies exist whose results do not allow for strong recommendations due to issues regarding methodology and acceptability. Recently, our own working group failed to apply a psychotherapy effective in palliative cancer patients to ALS patients (publication in preparation, see https://clinicaltrials.gov/ct2/show/NCT03975608).
Therefore, concepts feasible in other populations may not meet the specific needs of ALS patients. Indeed, various disease-specific facilitators have been identified such as flexible format, diseasespecific content tailoring, fostering of patient autonomy, but also barriers such as high effort in reaching and undergoing the intervention and functional decline. Based on such findings, psychotherapeutic programs for ALS patients should be co-designed within a participatory approach to overcome problems with feasibility and acceptability. However, the investigators identified only one study applying a similar approach; however, it was placed in a complete different health care context.
The investigators herein envisage a conceptual phase closely collaborating with various contributors, i.e., patients, caregivers and medical staff. The first objective is to assess the ability and benefit in collaborating with ALS patients in psychosocial intervention research. As second objective, contributors will prioritize their needs in psychological interventions regarding format, content and techniques. Results will be used in an exploratory trial to co-design a psychotherapeutic program ensuring good feasibility and acceptability.
The research questions of the first objective are the following:
- How high is the response rate of contributors to be involved in this participatory project?
- Which participative methods are applicable among ALS patients or need to be adapted?
- How do contributors evaluate the possbility to collaborate in psychosocial intervention research?
- What are the lessons learned and how can they be transferred to participatory psychosocial intervention research among severe (neurodegenerative) diseases? The main research questions related to the second objective are the following:
- How do contributors prioritize treatment-related factors in format, content and techniques?
- Which factor-specific barriers for feasibility and acceptability are anticipated by contributors?
- What are the main findings to serve as starting point for co-designing a disease-specific treatment program within an exploratory future trial?
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
- The study population includes 20 dyads of individuals affected by ALS and their caregivers, 4 expert patients, and 10 healthcare professionals. The recruitment is conducted through patient networks and personal contacts established by the patient representative and the project leader (e.g., within neuropalliative networks). The project leader will also invite medical personnel through his networks and in the course of his clinical work (e.g., within the "Clinic for Motor Neuron Diseases" at Leipzig University Hospital) to participate in the study. Affected individuals may also be invited to participate in the study by the project leader during their medical treatment.
Key inclusion criteria (6 listed)
- patients met criteria for definite/laboratory-supported probable/clinically probable/possible familial or sporadic ALS (diagnostically synonymous with MND) or MND variants (progressive muscular atrophy or primary lateral sclerosis according to the revised El Escorial criteria
- ≥ 18 years old
- fluent in German
- ability to communicate thoughts and feelings
- ability to provide written consent
Key exclusion criteria (4 listed)
- under 18 years old
- had a clinical need for gastrostomy feeding or non-invasive ventilation
- had a diagnosis of dementia
- inability to consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| case focus groupsThe study is in a monocentric, exploratory, participatory study conceptualization phase. Within the study, a mixed-methods assessment involves various interview and group exercise formats among scientists, medical personnel, affected individuals, and their caregivers to develop components for a future psychotherapeutic program for ALS patients and their caregivers. Therapists provide an overview of therapy forms by presenting components based on format, content, and applied techniques. Case studies and focus groups are used for practical experience for the participants. Participants qualitatively assess the significance of therapeutic approaches and make a quantitative prioritization to establish a ranking of therapy components. | Behavioural | – |
Primary outcome
Response rate
Time frame: through study completion, an average of 1 year
The investigators will assess the amount of eligible patients which are willing to participate in the study relative to the amount of patients who were invited to participate.
1 secondary outcome
Level of Quality of Life
Time frame: through study completion, an average of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2024.
- Derived from this study: PubMed 41057832Heyne S, Kuzmanova A, Esser P, Linse K, Gunther R, Mehnert-Theuerkauf A, Metelmann M. How can we reduce psychological burden for patients of amyotrophic lateral sclerosis and their family caregivers? - Insights from the participatory multi-method study "potentiALS". BMC Neurol. 2025 Oct 7;25(1):414. doi: 10.1186/s12883-025-04440-w.
- Individual participant dataSharing planned: No
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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.
Moritz Metelmann, PhD principal investigator
Universitätsklinikum Leipzig
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 University of Leipzig 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 6 inclusion and 4 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 4 Jun 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 Moritz Metelmann, PhD (+49 341 97 24209, moritz.metelmann@medizin.uni-leipzig.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Response rate (time frame: through study completion, an average of 1 year). 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 NCT06441448, 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 4 Jun 2024.