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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00030799

Enrollment

Registered

2023-02-07

Start date

2023-03-13

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

F00.1 F00.2

Interventions

Group 1: Patients fulfilling the inclusion criteria who consent to research participation get two appointments at different places (clinic vs. home place). At both places the capacity to consent to an

Eligibility

Sex/Gender

All

Age

65 Years to No maximum

Inclusion criteria

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: Exclusion criteria are a severe dementia (confirmed clinical diagnosis or a MMSE-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.

Design outcomes

Primary

Measure	Time frame
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).	—

Measure

Time frame

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

Measure	Time frame
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.	—

Countries

Germany

Contacts

Public ContactJanina Florack

Universität Siegen

janina.florack@uni-siegen.de02717405008

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 9, 2026