Decision-making places for people with dementia in Alzheimer's disease - part 2: Supporting advance decision-making by improving person-environment fit

Not Applicable

Recruiting

• Conditions: F00.2; F00.1; Dementia in Alzheimer disease with late onset; Dementia in Alzheimer disease, atypical or mixed type

• Registration Number: DRKS00030799
• Lead Sponsor: niversität Siegen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-02-07
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

Patients of the memory clinics with a suspected or confirmed diagnoses of Alzheimer’s dementia (F00.1) or a mixed type of Alzheimer’s dementia (F00.2). The inclusion process will be based on the decision tree for the inclusion of non-consenting individuals in medical research (Scholten et al., in preparation). This allows us to include participants with questionable capacity to consent.

Exclusion Criteria

Exclusion criteria are a severe dementia (confirmed clinical diagnosis or a MMSE-score < 10), delirium, intellectual disability, severe mental illness (e.g., clinical diagnosis of severe depression or a GDS-score > 10), lack of capacity to consent to medical research with simultaneous incapacity for supported decision making by a relative or proxy, no assent by the patient, uncompensated pronounced sensory deficits, or insufficient knowledge of the German language, which makes the understanding of the study documents and/or the interview impossible.

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary endpoint is the capacity to consent to create an advance directive. This endpoint will be assessed at both decision-making places (twice per person) using the Competence Assessment Tool - Advance Directive (CAT-AD) at the beginning of each session. This instrument was adapted within the DECIDE-project for advance directives in people with dementia in Alzheimer's Disease, based on well-known instruments for standardized assessment of the capacity to consent (MacCAT-T, Grisso & Applebaum, 1998; DCAT-PAD, Elbogen, 2007).

Secondary Outcome Measures

Name	Time	Method
Secondary endpoints respectively covariates are subjective task complexity, decisional conflicts, anxiety in the decision-making situation, severity of dementia and depression, perceived sense of belonging to the home place, the need for autonomy in medical decision-making, health literacy, sociodemographic variables.