To help community dwelling people with progressive chronic disabilities, such as Alzheimer*s Disease and Parkinson*s Disease, to retain their autonomy and quality of life as much as possible and to support their informal caregivers by developing and…
ID
Source
Brief title
Condition
- Cognitive and attention disorders and disturbances
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome measure of the one group pretest-posttest study are user
friendliness and usefulness of the ROSETTA system. For the assessment of user
friendliness and usefulness of the system a semi-structured questionnaire (for
persons with dementia and carers) will be developed, based on experiences with
such a questionnaire in the COGKNOW project. This questionnaire will be
shortened and further adapted based on the functionalities that will be
available on the final prototype.
The primary outcome measure of the RCT concerns the impact of the system on the
autonomy, quality of life of the elderly people with chronic disabilities and
the burden, feelings of competence and quality of life of their informal carers.
The experienced autonomy will be assessed with a questionnaire developed by
Meiland and Dröes (2006), based on the Mastery scale of Pearlin and Schooler
(1978) and an adaptation of selected questions from the WHOQOL-100 (WHO, 1998).
To assess the quality of life of persons with dementia, the QoL-AD (Logsdon et
al., 1999, 2002) will be administered. This instrument consists of 13 questions
(e.g. on physical health, mood, memory, family, friends, life as a whole) and
it can be used by people with dementia with MMSE scores as low as three.
To assess the burden and feelings of competence of informal carers, two
questions on experienced burden will be administered and the Short Sense of
Competence Questionnaire (SSCQ; Vernooij-Dassen et. al. 1999) will be used. The
quality of life of informal carers will be assessed with two items on the
overall judgement of their quality of life (from the MDS-NPO).
Secondary outcome
Delay of nursing home admission of the elderly persons with a chronic disease
is the secondary outcome measure. Nursing home admission of participants will
be recorded. The user-friendliness, usefulness and impact of the system on the
domains of daily life that are mentioned before, will also be evaluated by
qualitative open face-to-face interviews with persons with dementia and their
carers, and diaries of the participants (with positive and negative experiences
in using the system) will be studied.
Various patient, carer and context characteristics will be inventoried among
informal caregivers. Among these are demographic characteristics, insight in
the illness, style of caregiving, care needs and use of services.
Background summary
Titel: The ROSETTA Project; Guidance and Awareness Services for Independent
Living
The European society is aging. Not only are there more elderly people, their
mean age also will be higher. As a result, we will have more elderly people who
will have more years to develop chronic diseases. It is expected that the
capacity of care and support services will not rise accordingly, thus
alternative solutions will have to be developed to meet the care and support
needs of the elderly. Assistive technologies may provide such alternatives. In
the ROSETTA project a technological assistive device will be developed together
with potential end-users and domain experts. In this development we will focus
mainly on the prevention, early detection and efficient management of treatable
psychosocial and physical consequences of chronic diseases that are accompanied
by progressive cognitive decline and an increased risk of straying and falling
during the advanced stages of the disease. Examples of such diseases are
Alzheimer*s disease, other dementias and Parkinson*s disease.
Study objective
To help community dwelling people with progressive chronic disabilities, such
as Alzheimer*s Disease and Parkinson*s Disease, to retain their autonomy and
quality of life as much as possible and to support their informal caregivers by
developing and providing an ICT system that offers activity guidance and
awareness services for independent living. The aim of this evaluation study is
to assess the user-friendliness, usefulness and impact of the ROSETTA system on
autonomy and quality of life of persons with dementia and on burden, feelings
of competence and quality of life of their informal caregivers.
Study design
A one-group pretest-post test design will be performed to investigate the
user-friendliness and usefulness of the ROSETTA system.
A randomized controlled trial will be performed to study the impact of the
system on the autonomy, quality of life and delay of nursing home admission of
the elderly people with chronic disabilities and the burden, feelings of
competence and quality of life of their informal caregivers. Randomization will
occur with pre-stratification, consisting of four strata: persons with mild
dementia and Parkinson*s Disease, persons with mild dementia without
Parkinson*s Disease, persons with moderate to severe dementia with Parkinson*s
Disease, and persons with moderate to severe dementia with Parkinson*s Disease.
If possible, also living together or not with an informal caregiver will be
taken into account After this stratification, in each stratum a block
randomisation will be performed to assign persons to the experimental or
control group.
Intervention
The intervention consists of installation and use during eight to nine months
of the ROSETTA system in people*s own homes. The ROSETTA assistive technology
consists of a video home terminal with touch screen, a mobile device, sensors,
actuators and cameras, all integrated into a single system where messages and
alarms are processed in a centralized, redundant hosted environment outside the
home.
This ROSETTA system consists of three subsystems (that are integrated):
1) The UAS-AAPS (Unattended Autonomous Surveillance * Advanced Awareness and
Prevention Service). AAPS will be able to detect emergency situations and
generate alarms to informal carers or care organisations. By using movement
sensors and cameras in the house, potential emergency situations will be
detected. In emergency cases, a reminder will be pushed forward on the video
home terminal and the person with dementia will be asked to confirm whether he
is safe or not. When he is unsafe or when there is no response from the person
with dementia, a connection between the health care centre and the speak-listen
unit in the home of the person with dementia are automatically set up, enabling
a health care professional to assess the situation and provide help if needed.
2) The EDS (Early Detection System) software will record the daily pattern of
living of chronically ill elderly and any other residents (if a partner is
present) for several weeks by analysing signals from the sensors in the house.
After this period the software can:
* Generate graphs/indexes that offer a summary of the day-to-day pattern of
living and reveal predominantly the slowly occurring changes in it.
* Automatically indicate whether there are significant changes in the
day-to-day pattern of living.
The EDS will focus on sleep-wake rhythms, mobility inside and outside the
house, meal preparations, personal hygiene and number of reminders and
emergency alarms.
3) the EDN (the Elderly Day Navigator. the EDN will support the persons with
mild to moderate severe dementia in their daily functioning in the areas of
memory, social contact, daily activities and safety. This support will be
provided on a video home terminal and/or a mobile device. To support with
memory, the touch screen can provide reminders (for instance *you have an
appointment with the doctor at 10.00 a.m.), it shows a calendar with
activities, and a digital clock is displayed. To support in social contact
there is a picture dialling function on the screen with a photo address book.
To support in activities, digital photos can be shown on the screen. And
finally, to support in feelings of safety, there is a Help button, which
enables easy telephone contact with a relative. If this relative does not
answer the phone, the call may automatically be directed to another relative or
to a health care organisation. Also, to support with safety, persons with
dementia can de directed finding the way to their home with an outdoor
navigation tool on the mobile device. The persons with dementia and/or informal
carers may choose which functions of the EDN they want to be configured in the
system in their homes. During the research project, functions may me activated
and/or de-activated.
Study burden and risks
The data collection consists of semi-structured interviews and standardised
questionnaires that will be administered by trained interviewers among persons
with dementia and their carers (at pretest and posttest, short interviews
during the field test period). People from the experimental group will have the
ROSETTA system installed in their homes and will be enabled to use it for 9
months. In this period users are asked to keep a diary with their experiences
in using the system. The usage of several functions will be logged.
The ROSETTA system is intended to compensate for disabilities of persons with
dementia and to timely detect potential emergency situations or deterioration
in cognitive functioning. If this is the case, (informal) carers will be
notified, which will allow for a more efficient casemanagement. We expect that
the electronic device will enhance the objective and subjective safety.
However, the researchers will stay alert for any additional burden or risks for
the participants and avoid any disadvantuous situations.We expect that the
risks for the participants are negligible.
Valeriusplein 9
1075 BG Amsterdam
NL
Valeriusplein 9
1075 BG Amsterdam
NL
Listed location countries
Age
Inclusion criteria
Persons with mild to severe dementia with or without Parkinson's Disease and their informal carers (
Exclusion criteria
Living in an institutional setting
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 |
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CCMO | NL32872.029.10 |