A new concept of human-machine-interaction for the care of people with dementia in long-term care facilities
| ISRCTN | ISRCTN17968122 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN17968122 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | 100294374 |
| Sponsor | Hochschule für Technik und Wirtschaft Dresden – University of Applied Sciences |
| Funder | European Fund for Regional Developement (EFRD) |
- Submission date
- 13/12/2024
- Registration date
- 19/02/2025
- Last edited
- 19/02/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Background and study aims
This research is looking at whether a robot is beneficial in group therapy for people with dementia. Before examining the effect of the robot, this study will examine whether the robot is accepted by the therapists, therapy attendees and their relatives.
Who can participate?
As the study is limited to the place where the robot is, only residents of the Wohnpark Elsa Fenske in Dresden, their informal caregivers and professional caregivers working there can participate. Participants need to be 18 years or older.
What does the study involve?
The residents will attend group therapy multiple times a week. The therapy is called MAKS and is usually administered by two trained therapists. At different times during the study, a social robot will be part of the therapy as well providing different functions to the therapist and attendees.
What are the possible benefits and risks of participating?
Group therapy is proven to benefit its attendees regarding their autonomy and cognition. The feedback from all participants will influence how the robot is developed further. All methods are non-invasive. The robot is certified to be used in public spaces and does not pose a risk to the participants.
Where is the study run from?
The study is a project between the Universitätsklinikum Erlangen, the University of Applied Science Dresden and the Cultus gGmbH in Dresden. All parts of the study are carried out in Dresden, Germany.
When is the study starting and how long is it expected to run for?
July 2017 to September 2022
Who is funding the study?
The European Union via the European Fund for Regional Development.
Who is the main contact?
Elmar Graessel, elmar.graessel@fau.de
Contact information
Public, Scientific, Principal investigator
Schwabachanlage 6
Erlangen
91054
Germany
| Phone | +49 9131 8534 810 |
|---|---|
| elmar.graessel@fau.de |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Prospective single-centre longitudinal interventional study |
| Secondary study design | Non randomised study |
| Study type | Participant information sheet |
| Scientific title | Care4All - Initial - A new concept of human-machine-interaction for the care of people with dementia |
| Study acronym | Care4All |
| Study objectives | What changes due to the deployment of a social robot in a group therapy for people with dementia regarding the acceptance of the robot by professional caregivers, informal caregivers and therapy attendees? |
| Ethics approval(s) |
Approved 25/07/2018, Ethics Committee of the Friedrich-Alexander University Erlangen-Nuremberg (Ethik-Kommission der Friedrich-Alexander-Universität Erlangen-Nürnberg) (Krankenhausstr. 12, Erlangen, 91054, Germany; +49-9131-8522270; ethikkommission@fau.de), ref: 252_18 B |
| Health condition(s) or problem(s) studied | Group therapy for residents of long-term care facility with mild to moderate dementia |
| Intervention | This is a prospective single-centre longitudinal interventional study on the deployment of a social robot in group therapy for people with dementia without a control group. A social robot is deployed as a complement to the therapist in the psychosocial group therapy "MAKS" for a group of people with dementia in a long-term care facility. The functions of the robot are developed throughout the study and are designed to assist the therapist, e.g. taking attendance, reading news aloud, and singing karaoke with the attendees. The robot does not provide nursing care. The acceptance of the robot by professional and informal caregivers is assessed via questionnaires, and the acceptance by the therapy attendees is assessed using observational measures (Facial Action Coding System). |
| Intervention type | Other |
| Primary outcome measure(s) |
1. Therapy attendees: Observed emotions are measured using the Facial Action Coding System (FACS) at baseline, 5, 12, 16, and 31 months after baseline |
| Key secondary outcome measure(s) |
There are no secondary outcome measures |
| Completion date | 30/09/2022 |
Eligibility
| Participant type(s) | Health professional, Carer, Resident |
|---|---|
| Age group | Mixed |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 172 |
| Total final enrolment | 172 |
| Key inclusion criteria | Resident: 1. Mild to moderate dementia (Mini-Mental Status Examination score between 23 and 10) 2. Resident of long-term care facility 3. Consent to participate Health professional: 1. Working at a long-term care facility 2. consent to participate Carer: 1. Informal caregiver of the resident of the long-term care facility 2. Consent to participate |
| Key exclusion criteria | Resident: Unfit to participate in group setting Health professional: None Carer: None |
| Date of first enrolment | 09/11/2017 |
| Date of final enrolment | 15/08/2021 |
Locations
Countries of recruitment
- Germany
Study participating centre
Dresden
01067
Germany
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be availabe upon request from Elmar Graessel, elmar.graessel@fau.de. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 01/07/2022 | 17/12/2024 | Yes | No | |
| Other publications | 31/12/2020 | 17/12/2024 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
17/12/2024: Study's existence confirmed by the Ethics Committee of the Friedrich-Alexander University Erlangen-Nuremberg (Ethik-Kommission der Friedrich-Alexander-Universität Erlangen-Nürnberg).
