Health TrialsbyHealthPanel

Needs of ALS Patients With C9orf72 Mutation and Their Caregivers

ConditionAmyotrophic Lateral Sclerosis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorIstituto Auxologico Italiano

About this trial

Individuals with Amyotrophic Lateral Sclerosis (ALS) carrying the C9orf72 HRE mutation (C9Pos) often exhibit different phenotypic traits compared to other patients (C9Neg), presenting a more aggressive form of the disease, with also a higher frequency of comorbidity with frontotemporal dementia (ALS-FTD) and a greater prevalence of family history of ALS and/or other neurodegenerative diseases.

Considering these characteristics (comorbidity with FTD and family history of ALS and/or other neurodegenerative pathologies) as factors that have their importance from an assistance point of view, both C9orf72 patients and their caregivers may have particular needs in several respects, and in this sense this investigation is configured.

This survey aims to describe the various aspects related to the care and quality of life of C9orf72 ALS patients and their respective caregivers, with the goal of identifying actionable steps to improve the quality of life for both.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Diagnosis of ALS with mutation C9orf72 (C9Pos)

Age 18 years or older

Fluency in Italian language

Ability to understand the nature of the study and to reply to the questions in the online survey

Disqualifiers

Clinically relevant cognitive dysfunction

Incapacity to reply to at least half of the questions of the online survey

Hospital Anxiety and Depression Scale (HADS) ≥ 11

Caregiver of patient with diagnosis of ALS with mutation C9orf72 (C9Pos), who participates in this study

Trial population

ALS patients with mutation C9orf72 (C9Pos) and their caregivers

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Survey for ALS patients

    Other intervention

    Survey to describe the various aspects related to the care, needs and quality of life of C9orf72 ALS patients

  • Survey for Caregivers

    Other intervention

    Survey to describe the various aspects related to the care and time commitment for the assistance given by caregivers to C9orf72 ALS patients

Treatment groups

208 Participants
are divided into 2 treatment groups
Group A: ALS Patients with C9orf72 Mutation1 intervention
Group B: Caregivers1 intervention

Trial outcomes

Primary outcomes

1

Multidisciplinary care

ALS Patients with C9orf72 Mutation: Percentage with Multidisciplinary care

Time frame
At enrolment
2

Home care

ALS Patients with C9orf72 Mutation: Percentage with Home care

Time frame
At enrolment
3

Satisfaction of primary needs

ALS Patients with C9orf72 Mutation: Percentage with Satisfaction of primary needs

Time frame
At enrolment
4

Satisfaction of economic support

ALS Patients with C9orf72 Mutation: Percentage with Satisfaction of economic support

Time frame
At enrolment

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Istituto Auxologico Italiano

Lead sponsor

Source ClinicalTrials.gov
Apply now