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

• Conditions: G12.2; Motor neuron disease

• Registration Number: DRKS00012803
• Lead Sponsor: Charité, Ambulanz für ALS und andere Motoneuronenerkrankungen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-08-14
• Study Completion: 2017-10-27
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 100

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.

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.

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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).

Secondary Outcome Measures

Name	Time	Method
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.<br><br>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.