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DECIDE-2 Substudy I: Supported Advance Care Decision-Making in Dementia - An Integrated Approach for Practical Implementation

DECIDE-2 Substudy I: Supported Advance Care Decision-Making in Dementia - An Integrated Approach for Practical Implementation - DECIDE-2

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00036478
Enrollment
150
Registered
2025-04-17
Start date
2025-05-20
Completion date
Unknown
Last updated
2026-02-02

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

Conditions

F00 F01 F02 F03 F06.7

Interventions

Group 1: ACD intervention within DeCM: Participants (people with dementia) receive Dementia Care Management (DeCM), an established technique in which trained professionals (dementia care manager) ass

Sponsors

Universität Siegen
Lead Sponsor

Eligibility

Sex/Gender
All

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

MeasureTime 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

MeasureTime 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

Public ContactJanina Florack

Universität Siegen, Fakultät II, Department Psychologie

janina.florack@uni-siegen.de+49 2717405008

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 7, 2026