Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:34 PM
Ignite Modification Date:
2025-12-24 @ 4:34 PM
NCT ID:
NCT03823066
Eligibility Criteria:
Inclusion Criteria:
Persons with dementia:
* adults
* living at home
* all types of dementia
* light and moderate dementia (MMSE 10 and above)
* light dementia: living alone or with a relative at home (if alone: the relative should live in the neighborhood and be in daily contact with the person with dementia.)
* moderate dementia: living with a relative at home
* receive professional and/or non professional care or no care
* speak and understand German
* have no physical, auditory or visual restrictions, as this would make the application of the interventions impossible
* do not take any dementia-specific medication or have been taking dementia-specific medication for at least 3 months; condition stable and no change expected during the study period
* do not take antipsychotic and antidepressant medication or have been taking them for at least 14 days before study start
* children and pets in the household after previous individual discussion
Relatives:
* relatives of the participating persons with dementia (adults)
* relatives means family members, like spouse, daughter, aunt, ... or significant others like friends and neighbors
* living or not living with the person with dementia in the same household (in the case of moderate dementia, relatives must live in the same household)
* person with dementia receives or receives no professional care
* the relative provides or does not provide care
* If the person with dementia receives paid 24-hour care (regardless of whether they have mild or moderate dementia), a relative still has to be recruited as a participant (This relative must live in the same house or household and be in daily contact with the person with dementia).
* speak and understand German
Professional caregivers
* adults
* nurses
* speak and understand German
Dementia trainers
* adults
* trained as M.A.S. (Morbus Alzheimer Syndrome) trainer
* train the participants with dementia at home
* speak and understand German
ExclusioncCriteria:
Persons with dementia:
* known aggressive behavior
* frontotemporal Dementia
Healthy Volunteers:
False
Study:
NCT03823066
Study Brief:
Protocol Section:
NCT03823066