The objective is to study the effect of vignette cases on awareness in people with Alzheimer*s disease, vascular dementia and mixed dementia. Secondly, it is examined if awareness is associated with anxiety, depression and coping style.
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
dementie
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoints are the differences between the pre- and
post-intervention discrepancy score on three measures of awareness.
Secondary outcome
Secondary parameters are differences between baseline and endpoints measures of
anxiety and depression, and the correlation between the severity of these
(baseline) parameters and different domains of awareness.
Background summary
Interventions for increasing awareness in people with dementia have not yet
been studied. It has been shown that the vignette method is a useful instrument
as part of a multidimensional approach towards understanding awareness. The
present study will investigate the effects of the vignette method, not as a
diagnostic, but as an intervention tool to increase awareness in people with
dementia.
Study objective
The objective is to study the effect of vignette cases on awareness in people
with Alzheimer*s disease, vascular dementia and mixed dementia. Secondly, it is
examined if awareness is associated with anxiety, depression and coping style.
Study design
An exploratory single-arm open-label study.
Intervention
Participants are given vignette cases where behavior of elderly people is
described in short stories. Participants are subsequently asked four questions
with regard to the feelings and thoughts of the elderly people, which will
supposedly increase awareness.
Study burden and risks
The study contains a group of people with mild to moderate Alzheimer dementia,
vascular dementia or mixed dementia. The burden and potential risk of the study
are minimal for participants, as participation takes approximately four hours
in total. When needed, participants can take a break while filling in the
questionnaires. It is not expected that participants will experience any
disturbance by the study, but it will be explained that they may discontinue
from the study at any moment without consequences.
We expect that this study will shed more light on measuring awareness in people
with dementia and may be the first step in developing a potential intervention
to increase this awareness. This could be of great help to improve dementia
health care. Increasing awareness in people with dementia could lead to
increased decision-making abilities and increased motivation for seeking and
participating in treatment.
Hereweg 80
Groningen 9725AG
NL
Hereweg 80
Groningen 9725AG
NL
Listed location countries
Age
Inclusion criteria
- The subject has a caregiver who lives with him/her and who is willing to participate
- The subject has been diagnosed with Alzheimer*s disease, vascular dementia or with mixed dementia
- The subject scores a 1 (mild dementia) or 2 (moderate dementia) on the Clinical Dementia Rating Scale
- The subject is able to communicate in Dutch without a translator
- Healthcare professional estimates impaired awareness with a score of >1 on a Likert scale of 1-5.
Exclusion criteria
- It is not possible to enter the study when the caregiver has cognitive disabilities or is too overburdened
- Subjects with psychiatric disorders will be excluded
- Subjects with a history of substance abuse, head trauma or brain illness other than dementia will be excluded
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL60590.042.17 |