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

Organizational Data

DRKS-ID:
DRKS00030799
Recruitment Status:
Recruiting ongoing
Date of registration in DRKS:
2023-02-07
Last update in DRKS:
2024-05-02
Registration type:
Prospective

Acronym/abbreviation of the study

DECIDE

URL of the study

https://www.uni-siegen.de/lwf/departments/psychologie/professuren/haberstroh/forschung/projekt_decide.html?lang=de

Brief summary in lay language

No Entry

Brief summary in scientific language

The aim of the 'Spatial Intervention Study' of the DECIDE project is to examine an innovative, resource-oriented approach to supported decision-making (SDM) that focuses on the relational aspects and belonging processes of people with dementia in Alzheimer’s disease (PwAD). We hypothesize that talking to PwAD in their highly familiar home environment (as opposed to a clinical setting) will reduce the complexity of the decision-making process and thus significantly enhance their overall capacity to consent. We are recruiting people with a suspected or confirmed diagnosis of Alzheimer's dementia from two memory clinics, with a sample size of N = 88. We are using a randomized crossover design to investigate the intervention effect of the decision-making place on the capacity to consent. In addition to the capacity to consent as the primary outcome, different secondary outcomes (e.g., subjective task complexity, decisional conflict) and suspected moderating or mediating variables (e.g., meaning of home, demographic characteristics) will be assessed.

Health condition or problem studied

ICD10:
F00.1 - Dementia in Alzheimer disease with late onset
ICD10:
F00.2 - Dementia in Alzheimer disease, atypical or mixed type
Healthy volunteers:
No

Interventions, Observational Groups

Arm 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 advance directive will be assessed. Participants of the 1st study arm will have their first appointment at the clinic (control) and their second appointment at their home place (intervention).
Arm 2:
Participants of the 2nd study arm will have their first appointment at their home place (intervention) and their second appointment at the clinic (control) .

Endpoints

Primary outcome:
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:
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.

Study Design

Purpose:
Other
Allocation:
Randomized controlled study
Control:
  • Other
Phase:
N/A
Study type:
Interventional
Mechanism of allocation concealment:
No Entry
Blinding:
No
Assignment:
Crossover
Sequence generation:
No Entry
Who is blinded:
No Entry

Recruitment

Recruitment Status:
Recruiting ongoing
Reason if recruiting stopped or withdrawn:
No Entry

Recruitment Locations

Recruitment countries:
  • Germany
Number of study centers:
Multicenter study
Recruitment location(s):
  • University medical center Gedächtnisambulanz der Klinik für Psychiatrie, Psychosomatik & Psychotherapie Frankfurt a.M.
  • Medical center Gedächtnisambulanz des Klinikums Siegen Siegen

Recruitment period and number of participants

Planned study start date:
2023-03-01
Actual study start date:
2023-03-13
Planned study completion date:
2024-07-31
Actual Study Completion Date:
No Entry
Target Sample Size:
80
Final Sample Size:
No Entry

Inclusion Criteria

Sex:
All
Minimum Age:
65 Years
Maximum Age:
no maximum age
Additional 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.

Addresses

Primary Sponsor

Universität Siegen
Adolf-Reichwein-Straße 2a
57076 Siegen
Germany
Telephone:
No Entry
Fax:
No Entry
Contact per E-Mail
URL:
No Entry
Investigator Sponsored/Initiated Trial (IST/IIT):
Yes

Contact for Scientific Queries

Universität Siegen, Fakultät V, Department Psychologie
Prof. Dr. Julia Haberstroh
Adolf-Reichwein-Straße 2a
57076 Siegen
Germany
Telephone:
02717404053
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Contact for Public Queries

Universität Siegen
Janina Florack
Adolf-Reichwein-Straße 2a
57076 Siegen
Germany
Telephone:
02717405008
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Principal Investigator

Universität Siegen, Fakultät V, Department Psychologie
Prof. Dr. Julia Haberstroh
Adolf-Reichwein-Straße 2a
57076 Siegen
Germany
Telephone:
02717404053
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Sources of Monetary or Material Support

Public funding institutions financed by tax money/Government funding body (German Research Foundation (DFG), Federal Ministry of Education and Research (BMBF), etc.)

Bundesministerium für Bildung und Forschung, DLR Projektträger Bereich Gesundheit
Heinrich-Konen-Straße 1
53227 Bonn
Germany
Telephone:
No Entry
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Ethics Committee

Address Ethics Committee

Ethikkommission der Ärztekammer Westfalen-Lippe und der Westfälischen Wilhelms-Universität Münster
Gartenstraße 210-214
48147 Münster
Germany
Telephone:
+49-251-9292460
Fax:
+49-251-9292478
Contact per E-Mail
URL:
No Entry

Vote of leading Ethics Committee

Date of ethics committee application:
2022-02-03
Ethics committee number:
2022-088-f-S
Vote of the Ethics Committee:
Approved
Date of the vote:
2022-05-19

Further identification numbers

Other primary registry ID:
No Entry
EudraCT Number:
No Entry
UTN (Universal Trial Number):
No Entry
EUDAMED Number:
No Entry

IPD - Individual Participant Data

Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
Yes
IPD Sharing Plan:
The anonymous data building the basis for our published results will be accessible for other researchers via PsychData, a German data-sharing platform for psychological research (www.psychdata.de). Study protocols and codebooks are also going to be shared. After publication the data will be made available for other researchers between six months and ten years if they have specific and reasonable requests for data usage and sign the data usage agreement.

Study protocol and other study documents

Study protocols:
Florack, J., Abele, C., Baisch, S., Forstmeier, S., Garmann, D., Grond, M., ... & Haberstroh, J. (2023). Project DECIDE, part II: decision-making places for people with dementia in Alzheimer’s disease: supporting advance decision-making by improving person-environment fit. BMC Medical Ethics, 24(1), 1-11.
Study abstract:
No Entry
Other study documents:
No Entry
Background literature:
No Entry
Related DRKS studies:
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Publication of study results

Planned publication:
No Entry
Publikationen/Studienergebnisse:
No Entry
Date of first publication of study results:
No Entry
DRKS entry published for the first time with results:
No Entry

Basic reporting

Basic Reporting / Results tables:
No Entry
Brief summary of results:
No Entry