F00 F01 F02 F03 F06.7
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Confirmed diagnosis of mild to moderate dementia (F00-F03) or mild cognitive disorder (F06.7), diagnosed by a physician specialised in neurology or psychiatry and based on ICD-10 criteria.
Exclusion criteria
Exclusion criteria: Severe dementia (MMSE score < 11) lack of capacity to consent to medical research (and incapacity for supported decision-making with relative or proxy participation in sub-study 2
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint 1 is the prevalence and validity of advance healthcare planning documents. The primary endpoint 2 is the caregiver burden. Closed questions are used that were designed and used during the first project period. In addition to the existence of various advance care documents (yes/no), the validity of an advance directive, if present, is also collected, with valid in the sense that it was both voluntarily given and based on informed consent. The primary endpoints will be collected for participants in both study arms at the first and last visit. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints are patient autonomy and patient-caregiver congruence in preference. They will be collected using corresponding questionnaires. Initially, decisional conflict was included as one autonomy-related outcome, but was excluded during the pilot study due to poor understanding of the questions. | — |
Countries
Germany
Contacts
Universität Siegen, Fakultät II, Department Psychologie