Trial document




drksid header

  DRKS00012803

Trial Description

start of 1:1-Block title

Title

A mixed methods study to analyse the requirements for a technical assistance system for ALS-patients

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym

[---]*

end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial

[---]*

end of 1:1-Block url
start of 1:1-Block public summary

Brief Summary in Lay Language

The presented study is part of the joint project "ROBINA - robot-supported services for individual- and resource-focused intensive and palliative care for people with amyotrophic lateral sclerosis (ALS)" within the BMBF call "innovations for intensive and palliative care". This study aims to analyse the ALS treatment processes on the one hand, and the requirements to the robotic assistive system within the intensive and palliative setting on the other hand. For this purpose, ALS-patients as well as their formal and informal caregivers will be interviewed.
Aims of the study: - determination of the technical and non-technical requirements to technical assistive systems supporting the long-term care and preservation of autonomy of ALS-patients - definition of the application fields and target group(s) for technical assistive systems within the ALS patient group.
Main research question: What are the requirements of ALS-patients and their formal and informal caregivers to technical assistive systems for the autonomy preservation of affected people?

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

Brief Summary in Scientific Language

Aim of the study is to assess the usage and acceptance of assisitive technologies, as well as their perceived benefits and use by patients with amyotrophic lateral sclerosis (ALS) and their formal and informal caregivers. The study is part of the joint project "ROBINA - robot-supported services for individual- and resource-focused intensive and palliative care for people with ALS" within the BMBF call "innovations for intensive and palliative care".
Aim of the study:
- analysis of the technical and non-technical requirements to technical assistive systems for the autonomy preservation and homecare of ALS affected persons
- definition of the application fields and target group(s) for technical assistive systems within the ALS patient group.
Main research question:
What are the requirements of ALS-patients and their formal and informal caregivers to technical assistive systems for the autonomy preservation of affected people?
Secondary research questions:
1. Which physical functional failures due to ALS make the use of a robot-supported assistive systems possible and useful?
2. Which alterations of these determined functional failures are linked to new requirements to technical assistive systems for the support of ALS-patients?

end of 1:1-Block scientific synopsis
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00012803
  •   2017/08/14
  •   [---]*
  •   yes
  •   Approved
  •   EA1/121/17, Ethik-Kommission der Charité -Universitätsmedizin Berlin-
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  •   U1111-1199-7608 
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   G12.2 -  Motor neuron disease
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   Patients with ALS will receive an online questionnaire which consists of questions about their technology readiness level, technology use and physical functional ability (quantitative part). Additionally, 5 patients will be interviewed about the same areas plus will be asked to prioritize specific functionalities of the new robotic-supported assistive system (qualitative part).
    5 formal and 5 informal caregivers will be interviewed about their technology readiness level, technology use and caregiver stress.
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Non-interventional
  •   Observational study
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Other
  •   Single (group)
  •   N/A
  •   N/A
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

Questionnaire (ALS-patients): technology readiness level (Neyer, Felber, & Geb-hardt, 2012), functional ability of ALS-patients (ALSFRS-EX, Abdulla u. a., 2013), caregiver stress (Zarit Burden Interview, Zarit, Reever, & Bach-Peterson, 1980).

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

Secondary Outcome

Questionnaire (ALS-patients): self-developed questionnaire about the usage of technical equipment and about the prioritisation of specific functions of a newly developed robot-supported assistive system.

Interviews (ALS-patients, formal and informal caregivers): self-developed interview guidelines about the acceptance of and experience with technical assistive systems and the requirements to a newly developed robot-supported assistive system.

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   Germany
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

  • University Medical Center 
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   Actual
  •   2017/09/05
  •   100
  •   Monocenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional Inclusion Criteria

Patients:
aged 18 and above,
clinical diagnosis of ALS (according to El Escorial criteria).
Informal caregivers:
aged 18 and above;
persons closely related to the patient, who belong to his or her family or extended environment and substatially involved in the patient care.
Formal caregivers:
professionally trained caregiver or
caregiver assistant, experienced in ALS patient care.

end of 1:1-Block inclusion criteria add
start of 1:1-Block exclusion criteria

Exclusion Criteria

Patients:
lack of written consent,
lack of willingness to save and transfer pseudomynized health data,
incapacitated people due to cognitive deficits (at least a medium-level collateral dementia),
lack of written consent of the legal representative (if existent).
Informal caregivers:
lack of written consent,
presence of a heritable psychological stress disorder which makes an additional burden due to the interviews inacceptable.
Formal caregivers:
lack of written consent.

end of 1:1-Block exclusion criteria
start of 1:n-Block addresses

Addresses

  • start of 1:1-Block address primary-sponsor
    • Charité, Ambulanz für ALS und andere Motoneuronenerkrankungen
    • Mr.  Dr.  André  Maier 
    • Augustenburger Platz 1
    • 13353   Berlin
    • Germany
    end of 1:1-Block address primary-sponsor
    start of 1:1-Block address contact primary-sponsor
    end of 1:1-Block address contact primary-sponsor
  • start of 1:1-Block address scientific-contact
    • Charité, Ambulanz für ALS und andere Motoneuronenerkrankungen
    • Mr.  Dr.  André  Maier 
    • Augustenburger Platz 1
    • 13353  Berlin
    • Germany
    end of 1:1-Block address scientific-contact
    start of 1:1-Block address contact scientific-contact
    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address public-contact
    • Charité, Ambulanz für ALS und andere Motoneuronenerkrankungen
    • Mr.  Dr.  André  Maier 
    • Augustenburger Platz 1
    • 13353  Berlin
    • Germany
    end of 1:1-Block address public-contact
    start of 1:1-Block address contact public-contact
    end of 1:1-Block address contact public-contact
end of 1:n-Block addresses
start of 1:n-Block material support

Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Bundesministerium für Bildung und Forschung Dienstsitz Berlin
    • Hannoversche Straße 28-30
    • 10115  Berlin
    • Germany
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    end of 1:1-Block address contact materialSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting complete, follow-up complete
  •   2017/10/27
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

end of 1:n-Block publications
* This entry means the parameter is not applicable or has not been set.