potentiALS - Quality of Life Among Patients With Amyotrophic Lateral Sclerosis

NCT06441448 | Recruiting

• 1 other identifier: 01KG2321
• Study Type: observational
• Target: 54
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Amyotrophic Lateral Sclerosis

Keywords

participatory aproach; quality of life; psychotherapeutic program

Outcome Measures

Primary Outcomes (1)

• 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.

  through study completion, an average of 1 year

Secondary Outcomes (1)

• Level of Quality of Life

  through study completion, an average of 1 year

Interventions

case focus groups BEHAVIORAL

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.

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

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.

You may qualify if:

• 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.

You may not qualify if:

• under 18 years old
• had a clinical need for gastrostomy feeding or non-invasive ventilation
• had a diagnosis of dementia
• inability to consent

Sponsors & Collaborators

• University of Leipzig: lead
• Leipzig University Medical Center: collaborator

Study Sites (1)

University Medical Center Leipzig

Leipzig, Saxony, 04103, Germany

RECRUITING

Related Publications (1)

• 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.

  PMID: 41057832 DERIVED

MeSH Terms

Conditions

Amyotrophic Lateral Sclerosis

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

Study Officials

• Moritz Metelmann, PhD

  Universitätsklinikum Leipzig

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Moritz Metelmann, PhD

CONTACT

+49 341 97 24209; moritz.metelmann@medizin.uni-leipzig.de

Svenja Heyne, MSc. Psych

CONTACT

+49 341 97 15438; svenja.heyne@medizin.uni-leipzig.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 5, 2024
• First Posted: June 4, 2024
• Study Start: January 1, 2024
• Primary Completion: August 31, 2024
• Study Completion: December 31, 2024
• Last Updated: June 4, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)